Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02522299
Previous Study | Return to List | Next Study

A Study to Evaluate the Safety, Efficacy and Changes in Induced Sputum and Blood Biomarkers Following Daily Repeat Doses of Inhaled GSK2269557 in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Acute Exacerbation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02522299
Recruitment Status : Completed
First Posted : August 13, 2015
Results First Posted : November 25, 2019
Last Update Posted : September 5, 2021
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Pulmonary Disease, Chronic Obstructive
Interventions Drug: GSK2269557
Drug: Placebo
Device: DISKUS
Device: ELLIPTA
Enrollment 44
Recruitment Details A total 44 participants with Chronic obstructive pulmonary disease (COPD) were enrolled in this study. The study had a protocol amendment to reflect changes in manufacturing device from DISKUS to ELLIPTA.but the 2 treatment arms remained the same i.e. Placebo and GSK2269557 (Nemiralisib [NEMI]).There was no intent to compare two devices.
Pre-assignment Details As the switch to the ELLIPTA device was intended to be a comparable treatment, the treatment groups Placebo DISKUS and Placebo ELLIPTA were combined as All Placebo treatment group. Similarly, the treatment groups NEMI DISKUS and NEMI ELLIPTA were combined as All NEMI treatment group.
Arm/Group Title All Placebo All NEMI
Hide Arm/Group Description Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS or ELLIPTA dry powder inhaler (DPI). Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
Period Title: Overall Study
Started 22 22
Completed 18 21
Not Completed 4 1
Reason Not Completed
Adverse Event             2             0
Physician Decision             0             1
Withdrawal by Subject             2             0
Arm/Group Title All Placebo All NEMI Total
Hide Arm/Group Description Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS or ELLIPTA dry powder inhaler (DPI). Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days Total of all reporting groups
Overall Number of Baseline Participants 22 22 44
Hide Baseline Analysis Population Description
The study had a protocol amendment to reflect changes in manufacturing device from DISKUS to ELLIPTA after study had been initiated, but the 2 treatment arms remained the same i.e. Placebo and NEMI. There was no intent to compare two devices.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 22 participants 44 participants
64.0  (8.20) 66.1  (7.32) 65.1  (7.75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
Female
10
  45.5%
11
  50.0%
21
  47.7%
Male
12
  54.5%
11
  50.0%
23
  52.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
White - White/Caucasian/European Heritage
22
 100.0%
22
 100.0%
44
 100.0%
1.Primary Outcome
Title Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group
Hide Description Saline-induced sputum samples were collected at the indicated time-points to determine the alterations in previously identified immune cell mechanisms specifically related to neutrophil function by identifying the changes in mRNA transcriptome in induced sputum. Baseline was defined as screening visit. The log2 transformed mRNA intensities for each probe set were analyzed in a separate repeated measures model. Back transformed baseline-adjusted ratios and two-sided unadjusted p-values were calculated for each visit as the specified time-point value/baseline value. These ratios were converted to fold change values; if ratio >= 1 then fold change=ratio or if ratio < 1 then fold change = -1/ratio. Data for pre-specified probe sets that meet the criteria fold change >1.5 or <-1.5 and p<0.05 for All NEMI, All Placebo and All NEMI/All Placebo group is presented in outcome measure 1, 2 and 3 respectively. In the categories column we have included time-point, Probe ID and Gene label.
Time Frame Baseline (Screening) and Days 12, 28 and 84
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population comprised of all randomized participants who received at least one dose of the study treatment.
Arm/Group Title All NEMI
Hide Arm/Group Description:
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: Fold change
Day 12,222834_s_at, GNG12 1.78
Day 12,210390_s_at, CCL15 1.72
Day 12,212294_at, GNG12 1.67
Day 12,226497_s_at, FLT1 1.57
Day 12, 204356_at, LIMK1 1.54
Day 12, 203923_s_at, CYBB 1.51
Day 12, 219748_at, TREML2 -1.51
Day 12, 1555086_at, STAT5B -1.51
Day 12, 211883_x_at, CEACAM1 -1.51
Day 12, 224909_s_at, PREX1 -1.51
Day 12, 239170_at, ACTR3 -1.51
Day 12, 212550_at, STAT5B -1.52
Day 12, 202178_at, PRKCZ -1.52
Day 12, 219633_at, TTPAL -1.53
Day 12, 204285_s_at, PMAIP1 -1.56
Day 12, 1555088_x_at, STAT5B -1.56
Day 12, 227817_at, PRKCB -1.57
Day 12, 205632_s_at, PIP5K1B -1.58
Day 12, 202018_s_at, LTF -1.59
Day 12, 232763_at, TLN1 -1.59
Day 12, 202948_at, IL1R1 -1.60
Day 12, 1569830_at, PTPRC -1.63
Day 12, 215561_s_at, IL1R1 -1.69
Day 12, 228031_at, TTPAL -1.71
Day 12, 209498_at, CEACAM1 -1.75
Day 12, 204563_at, SELL -1.87
Day 12, 205118_at, FPR1 -1.93
Day 12, 236172_at, LTB4R -1.96
Day 12, 212372_at, MYH10 -2.12
Day 28, 244313_at, CR1 1.99
Day 28, 213093_at, PRKCA 1.53
Day 28, 205778_at, KLK7 -1.54
Day 84, 233694_at, HSPA1L 1.88
Day 84, 208304_at, CCR3 1.83
Day 84, 215101_s_at, CXCL5 1.82
Day 84,214974_x_at ,CXCL5 1.80
Day 84, 207852_at, CXCL5 1.63
Day 84, 1555759_a_at, CCL5 -1.51
Day 84, 207535_s_at, NFKB2 -1.53
Day 84, 234212_at, ACTR2 -1.57
Day 84, 207794_at, CCR2 -1.58
Day 84, 206978_at, CCR2 -1.64
Day 84, 211889_x_at, CEACAM1 -1.69
Day 84, 206219_s_at, VAV1 -1.71
Day 84, 209498_at, CEACAM1 -1.72
Day 84, 206576_s_at, CEACAM1 -1.75
Day 84, 211883_x_at, CEACAM1 -1.76
2.Primary Outcome
Title Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group
Hide Description Saline-induced sputum samples were collected at the indicated time-points to determine the alterations in previously identified immune cell mechanisms specifically related to neutrophil function by identifying the changes in mRNA transcriptome in induced sputum. Baseline was defined as screening visit. The log2 transformed mRNA intensities for each probe set were analysed in a separate repeated measures model. Back transformed baseline-adjusted ratios and two-sided unadjusted p-values were calculated for each visit as the specified time-point value/baseline value. These ratios were converted to fold change values; if ratio >= 1 then fold change=ratio or if ratio < 1 then fold change = -1/ratio. Data for pre-specified probe sets that meet the criteria fold change >1.5 or <-1.5 and p<0.05 for All NEMI, All Placebo and All NEMI/All Placebo group is presented in outcome measure 1, 2 and 3 respectively. In the categories column we have included time-point, Probe ID and Gene label.
Time Frame Baseline (Screening) and Days 12, 28 and 84
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population.
Arm/Group Title All Placebo
Hide Arm/Group Description:
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS or ELLIPTA dry powder inhaler (DPI).
Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: Fold Change
Day 12, 222834_s_at, GNG12 2.29
Day 12, 207852_at, CXCL5 1.81
Day 12, 212294_at, GNG12 1.79
Day 12, 209576_at, GNAI1 1.61
Day 12, 213281_at, JUN 1.51
Day 12, 222880_at, AKT3 1.51
Day 12, 205026_at, STAT5B -1.50
Day 12, 201783_s_at, RELA -1.50
Day 12, 227404_s_at, EGR1 -1.51
Day 12, 1552552_s_at,CLEC4C -1.54
Day 12, 211823_s_at,PXN -1.55
Day 12,206978_at,CCR2 -1.55
Day 12,206219_s_at,VAV1 -1.56
Day 12,219748_at,TREML2 -1.56
Day 12,207794_at,CCR2 -1.58
Day 12,211561_x_at,MAPK14 -1.59
Day 12,226507_at,PAK1 -1.59
Day 12,232068_s_at,TLR4 -1.60
Day 12,209282_at,PRKD2 -1.60
Day 12,226080_at,SSH2 -1.61
Day 12,212550_at,STAT5B -1.64
Day 12,212372_at,MYH10 -1.64
Day 12,214022_s_at,IFITM1 -1.66
Day 12,217484_at,CR1 -1.67
Day 12,206244_at,CR1 -1.68
Day 12,1552480_s_at,PTPRC -1.68
Day 12,1554114_s_at,SSH2 -1.69
Day 12,201601_x_at,IFITM1 -1.75
Day 12,205842_s_at,JAK2 -1.75
Day 12,228603_at, ACTR3 -1.75
Day 12,230100_x_at,PAK1 -1.77
Day 12,239307_at,MYH11 -1.88
Day 12,223750_s_at,TLR10 -1.88
Day 12,208488_s_at,CR1 -1.92
Day 12,204563_at,SELL -2.70
Day 28, 222834_s_at,GNG12 1.91
Day 84,226498_at,FLT1 4.10
Day 84,216598_s_at,CCL2 1.75
Day 84,1562439_at,NCOA3 1.52
Day 84,201087_at,PXN -1.52
Day 84,224909_s_at,PREX1 -1.52
Day 84,211823_s_at,PXN -1.53
Day 84,209615_s_at,PAK1 -1.54
Day 84,211561_x_at,MAPK14 -1.59
Day 84,203749_s_at,RARA -1.60
Day 84,219748_at,TREML2 -1.61
Day 84,207008_at,CXCR2 -1.66
Day 84,244313_at,CR1 -1.67
Day 84,202530_at,MAPK14 -1.69
Day 84,228648_at,LRG1 -1.71
Day 84,208488_s_at,CR1 -1.71
Day 84,228795_at,PRKCB -1.73
Day 84,1552480_s_at,PTPRC -1.76
Day 84,232068_s_at,TLR4 -1.77
Day 84,221060_s_at,TLR4 -1.78
Day 84,201601_x_at,IFITM1 -1.79
Day 84,202018_s_at,LTF -1.82
Day 84,217209_at,CEACAM3 -1.85
Day 84,214022_s_at,IFITM1 -1.89
Day 84,217552_x_at,CR1 -1.89
Day 84,203591_s_at,CSF3R -1.91
Day 84,205118_at,FPR1 -1.92
Day 84,1553297_a_at,CSF3R -1.96
Day 84,204563_at,SELL -2.23
Day 84,219669_at,CD177 -2.47
3.Primary Outcome
Title Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group
Hide Description Saline-induced sputum samples were collected at the indicated time-points to determine the alterations in previously identified immune cell mechanisms specifically related to neutrophil function by identifying the changes in mRNA transcriptome in induced sputum. For each probe set, the log2 transformed mRNA intensities were analyzed in separate repeated measures models. The models included a Treatment, Visit and Treatment*Visit term. The Visit consisted of 4 levels: Screening (Baseline), Day 12, Day 28 and Day 84, and the Treatment consisted of three levels: Null (when Visit = Screening), All Placebo and All NEMI. The fold changes were derived from the back transformed ratio from Baselines as fold change = ratio if ratio is >=1, else if ratio <1 then fold change = -1/ratio. Data for pre-specified probe sets that meet the criteria fold change >1.5 and p<0.05 for All NEMI, All Placebo and All NEMI/All Placebo group is presented in outcome measure 1, 2 and 3 respectively.
Time Frame Baseline (Screening) and Days 12, 28 and 84
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population.
Arm/Group Title All NEMI/All Placebo
Hide Arm/Group Description:
This arm is a comparison of All NEMI and All Placebo Arm
Overall Number of Participants Analyzed 44
Measure Type: Number
Unit of Measure: Fold Change
Day 12,200671_s_at,SPTBN1 -1.74
Day 12,226342_at,SPTBN1 -1.89
Day 12,200672_x_at,SPTBN1 -1.60
Day 12,209576_at,GNAI1 -1.62
Day 12,202178_at,PRKCZ -1.55
Day 28,244313_at,CR1 2.75
Day 28,223750_s_at,TLR10 2.66
Day 28,217552_x_at,CR1 2.25
Day 28,206244_at,CR1 2.01
Day 28,208488_s_at,CR1 1.95
Day 28,232068_s_at,TLR4 1.71
Day 28,1553297_a_at,CSF3R 1.71
Day 28,1552798_a_at,TLR4 1.68
Day 28,223943_s_at,GNG2 1.63
Day 28,221060_s_at,TLR4 1.58
Day 28,239695_at,JAK1 1.52
Day 28,234290_x_at,MYH14 -1.52
Day 28,1568377_x_at,DEFB124 -1.52
Day 28,1555765_a_at,GNG4 -1.53
Day 28,201464_x_at,JUN -1.57
Day 28,201465_s_at,JUN -1.68
Day 28,239381_at,KLK7 -1.69
Day 28,205778_at,KLK7 -1.71
Day 28,213281_at,JUN -1.72
Day 84,208304_at,CCR3 2.52
Day 84,1553297_a_at,CSF3R 2.25
Day 84,203591_s_at,CSF3R 1.98
Day 84,221060_s_at,TLR4 1.83
Day 84,202530_at,MAPK14 1.77
Day 84,244313_at,CR1 1.60
Day 84,203872_at,ACTA1 1.53
Day 84,216944_s_at,ITPR1 -1.51
Day 84,215195_at,PRKCA -1.66
Day 84,226498_at,FLT1 -5.18
4.Secondary Outcome
Title Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes
Hide Description siVaw was measured at FRC and TLC. Data was collected at longitudinal time points (Untrimmed data): Baseline (Screening), Day 12 & Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For Untrimmed data and SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (n=X1, X2 in the category title). This table presents the untrimmed data (in rows with categories containing untrimmed), SCRD12 scan trim pair data (in rows with categories containing Scan Trimmed and Day 12) and SCRD28 scan trim pair data (in rows with categories containing Scan Trimmed and Day 28) only.
Time Frame Baseline (Screening), Days 12 and 28
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
Arm/Group Title All Placebo All NEMI
Hide Arm/Group Description:
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS or ELLIPTA dry powder inhaler (DPI).
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
Overall Number of Participants Analyzed 22 22
Geometric Mean (95% Confidence Interval)
Unit of Measure: Milliliters per Liter
FRC,Scan Trimmed,Right Upper,Day 12,n=17,16 Number Analyzed 17 participants 16 participants
1.020
(0.854 to 1.217)
1.038
(0.880 to 1.225)
FRC,Scan Trimmed,Right Upper,Day 28,n=16,18 Number Analyzed 16 participants 18 participants
1.027
(0.838 to 1.258)
1.030
(0.924 to 1.147)
FRC,Scan Trimmed,Left Upper,Day 12,n=18,17 Number Analyzed 18 participants 17 participants
0.970
(0.798 to 1.180)
0.993
(0.857 to 1.151)
FRC,Scan Trimmed,Left Upper,Day 28,n=16,19 Number Analyzed 16 participants 19 participants
1.008
(0.779 to 1.304)
1.053
(0.937 to 1.184)
FRC,Scan Trimmed,Right Middle,Day 12,n=17,16 Number Analyzed 17 participants 16 participants
1.294
(0.904 to 1.852)
1.008
(0.856 to 1.188)
FRC,Scan Trimmed,Right Middle,Day 28,n=16,18 Number Analyzed 16 participants 18 participants
1.071
(0.773 to 1.484)
0.973
(0.865 to 1.093)
FRC,Scan Trimmed,Right Lower,Day 12,n=17,17 Number Analyzed 17 participants 17 participants
1.025
(0.873 to 1.204)
1.029
(0.858 to 1.236)
FRC,Scan Trimmed,Right Lower,Day 28,n=16,19 Number Analyzed 16 participants 19 participants
1.032
(0.872 to 1.222)
1.042
(0.924 to 1.174)
FRC,Scan Trimmed,Left Lower,Day 12,n=17,17 Number Analyzed 17 participants 17 participants
1.012
(0.894 to 1.145)
1.032
(0.886 to 1.201)
FRC,Scan Trimmed,Left Lower,Day 28,n=16,19 Number Analyzed 16 participants 19 participants
0.973
(0.862 to 1.097)
1.062
(0.974 to 1.157)
TLC,Scan Trimmed,Right Upper,Day 12,n=19,17 Number Analyzed 19 participants 17 participants
0.991
(0.908 to 1.080)
0.999
(0.876 to 1.141)
TLC,Scan Trimmed,Right Upper,Day 28,n=18,19 Number Analyzed 18 participants 19 participants
0.951
(0.870 to 1.040)
0.964
(0.860 to 1.081)
TLC,Scan Trimmed,Left Upper,Day 12,n=20,18 Number Analyzed 20 participants 18 participants
0.954
(0.897 to 1.014)
0.968
(0.852 to 1.101)
TLC,Scan Trimmed,Left Upper,Day 28,n=18,20 Number Analyzed 18 participants 20 participants
0.935
(0.860 to 1.017)
0.950
(0.872 to 1.035)
TLC,Scan Trimmed,Right Middle,Day 12,n=18,17 Number Analyzed 18 participants 17 participants
0.958
(0.835 to 1.099)
1.008
(0.891 to 1.140)
TLC,Scan Trimmed,Right Middle,Day 28,n=18,19 Number Analyzed 18 participants 19 participants
0.969
(0.837 to 1.122)
0.900
(0.815 to 0.994)
TLC,Scan Trimmed,Right Lower,Day 12,n=20,18 Number Analyzed 20 participants 18 participants
1.054
(0.936 to 1.187)
0.963
(0.853 to 1.087)
TLC,Scan Trimmed,Right Lower,Day 28,n=18,20 Number Analyzed 18 participants 20 participants
0.952
(0.848 to 1.068)
0.899
(0.814 to 0.993)
TLC,Scan Trimmed,Left Lower,Day 12,n=20,18 Number Analyzed 20 participants 18 participants
0.967
(0.911 to 1.026)
1.004
(0.887 to 1.136)
TLC,Scan Trimmed,Left Lower,Day 28,n=18,20 Number Analyzed 18 participants 20 participants
0.953
(0.852 to 1.066)
0.950
(0.868 to 1.040)
FRC,Untrimmed,Right Upper,Day 12,n= 17,16 Number Analyzed 17 participants 16 participants
0.900
(0.670 to 1.209)
1.071
(0.851 to 1.349)
FRC,Untrimmed,Right Upper, Day 28,n=16,18 Number Analyzed 16 participants 18 participants
1.001
(0.720 to 1.390)
1.073
(0.917 to 1.255)
FRC,Untrimmed,Left Upper, Day 12,n=18,17 Number Analyzed 18 participants 17 participants
1.001
(0.683 to 1.468)
0.956
(0.731 to 1.251)
Untrimmed,Left Upper, Day 28,n=16,19 Number Analyzed 16 participants 19 participants
1.082
(0.669 to 1.750)
1.065
(0.814 to 1.393)
FRC,Untrimmed,Right Middle, Day 12,n=17,16 Number Analyzed 17 participants 16 participants
1.347
(0.709 to 2.559)
1.058
(0.825 to 1.356)
FRC,Untrimmed,Right Middle, Day 28,n=16,18 Number Analyzed 16 participants 18 participants
1.118
(0.696 to 1.797)
1.007
(0.815 to 1.244)
FRC,Untrimmed,Right Lower, Day 12,n=17,17 Number Analyzed 17 participants 17 participants
1.237
(0.796 to 1.923)
1.014
(0.736 to 1.397)
FRC,Untrimmed,Right Lower, Day 28,n=16,19 Number Analyzed 16 participants 19 participants
1.241
(0.841 to 1.831)
1.031
(0.816 to 1.302)
FRC,Untrimmed,Left Lower, Day 12,n=17,17 Number Analyzed 17 participants 17 participants
0.967
(0.754 to 1.239)
1.002
(0.702 to 1.429)
FRC,Untrimmed,Left Lower, Day 28,n=16,19 Number Analyzed 16 participants 19 participants
0.815
(0.590 to 1.125)
1.142
(0.945 to 1.381)
TLC,Untrimmed,Right Upper,Day 12,n=19,17 Number Analyzed 19 participants 17 participants
0.982
(0.862 to 1.118)
1.002
(0.831 to 1.209)
TLC,Untrimmed,Right Upper, Day 28,n=18,19 Number Analyzed 18 participants 19 participants
0.884
(0.776 to 1.006)
0.941
(0.804 to 1.100)
TLC,Untrimmed,Left Upper, Day 12,n=20,18 Number Analyzed 20 participants 18 participants
0.955
(0.861 to 1.059)
0.942
(0.789 to 1.125)
TLC,Untrimmed,Left Upper, Day 28,n=18,20 Number Analyzed 18 participants 20 participants
0.949
(0.860 to 1.046)
0.926
(0.813 to 1.055)
TLC,Untrimmed,Right Middle, Day 12,n=18,17 Number Analyzed 18 participants 17 participants
0.942
(0.777 to 1.142)
0.970
(0.811 to 1.161)
TLC,Untrimmed,Right Middle, Day 28,n=18,19 Number Analyzed 18 participants 19 participants
0.691
(0.475 to 1.005)
0.892
(0.784 to 1.014)
TLC,Untrimmed,Right Lower, Day 12,n=20,18 Number Analyzed 20 participants 18 participants
1.131
(0.898 to 1.424)
0.895
(0.745 to 1.075)
TLC,Untrimmed,Right Lower, Day 28,n=18,20 Number Analyzed 18 participants 20 participants
0.948
(0.791 to 1.135)
0.865
(0.753 to 0.993)
TLC,Untrimmed,Left Lower, Day 12,n=20,18 Number Analyzed 20 participants 18 participants
0.982
(0.885 to 1.089)
0.989
(0.831 to 1.178)
TLC,Untrimmed,Left Lower, Day 28,n=18,20 Number Analyzed 18 participants 20 participants
0.894
(0.693 to 1.152)
0.967
(0.858 to 1.090)
5.Secondary Outcome
Title Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Lobes at Day 28
Hide Description siVaw is a measure of the volume in an individual's airway corrected for their lobar volume derived from the high resolution computed tomography (HRCT). It was measured at FRC and TLC. Data was collected at longitudinal time points (Untrimmed data): Baseline (Screening), Day 12 & Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For Untrimmed data and SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (represented by n=X1, X2 in the category title). This table presents the D12D28 scan trim pair data only.
Time Frame Baseline (Day 12) and Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
Arm/Group Title All Placebo All NEMI
Hide Arm/Group Description:
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS or ELLIPTA dry powder inhaler (DPI).
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
Overall Number of Participants Analyzed 22 22
Geometric Mean (95% Confidence Interval)
Unit of Measure: Milliliters per Liter
FRC,Scan Trimmed,Right Upper,Day 28,n=16,17 Number Analyzed 16 participants 17 participants
0.998
(0.917 to 1.086)
0.988
(0.909 to 1.074)
FRC,Scan Trimmed,Left Upper,Day 28,n=16,18 Number Analyzed 16 participants 18 participants
0.987
(0.905 to 1.077)
1.014
(0.904 to 1.137)
FRC,Scan Trimmed,Right Middle,Day 28,n=16,17 Number Analyzed 16 participants 17 participants
1.003
(0.876 to 1.149)
0.930
(0.828 to 1.043)
FRC,Scan Trimmed,Right Lower,Day 28,n=16,18 Number Analyzed 16 participants 18 participants
0.938
(0.845 to 1.041)
1.020
(0.884 to 1.176)
FRC,Scan Trimmed,Left Lower,Day 28,n=16,18 Number Analyzed 16 participants 18 participants
0.947
(0.849 to 1.057)
1.042
(0.905 to 1.200)
TLC, Scan Trimmed,Right Upper,Day 28,n=17,18 Number Analyzed 17 participants 18 participants
0.963
(0.875 to 1.061)
0.965
(0.928 to 1.004)
TLC, Scan Trimmed,Left Upper,Day 28,n=17,19 Number Analyzed 17 participants 19 participants
0.984
(0.896 to 1.079)
0.999
(0.940 to 1.061)
TLC, Scan Trimmed,Right Middle,Day 28,n=17,18 Number Analyzed 17 participants 18 participants
0.807
(0.601 to 1.084)
0.897
(0.829 to 0.971)
TLC, Scan Trimmed,Right Lower,Day 28,n=17,19 Number Analyzed 17 participants 19 participants
0.945
(0.848 to 1.052)
0.943
(0.892 to 0.997)
TLC, Scan Trimmed,Left Lower,Day 28,n=17,19 Number Analyzed 17 participants 19 participants
0.950
(0.863 to 1.046)
0.963
(0.868 to 1.069)
6.Secondary Outcome
Title Change From Baseline in siVaw at FRC and TLC for Individual Regions
Hide Description siVaw was measured at FRC and TLC. Data was collected at longitudinal time points (Untrimmed data): Baseline (Screening), Day 12 & Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For Untrimmed data and SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (n=X1, X2 in the category title).This table presents the untrimmed data (in rows with categories containing untrimmed), SCRD12 scan trim pair data (in rows with categories containing Scan Trimmed and Day 12) and SCRD28 scan trim pair data (in rows with categories containing Scan Trimmed and Day 28) only.
Time Frame Baseline (Screening), Days 12 and 28
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
Arm/Group Title All Placebo All NEMI
Hide Arm/Group Description:
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS or ELLIPTA dry powder inhaler (DPI).
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
Overall Number of Participants Analyzed 22 22
Geometric Mean (95% Confidence Interval)
Unit of Measure: Milliliters per Liter
FRC,Scan Trimmed,Upper,Day 12,n=18,17 Number Analyzed 18 participants 17 participants
0.996
(0.840 to 1.180)
1.024
(0.888 to 1.181)
FRC,Scan Trimmed,Upper,Day 28,n=16,19 Number Analyzed 16 participants 19 participants
1.011
(0.814 to 1.257)
1.029
(0.934 to 1.133)
FRC,Scan Trimmed,Lower,Day 12,n=17,17 Number Analyzed 17 participants 17 participants
1.003
(0.881 to 1.143)
1.039
(0.901 to 1.199)
FRC,Scan Trimmed,Lower,Day 28,n=16,19 Number Analyzed 16 participants 19 participants
0.991
(0.873 to 1.125)
1.041
(0.942 to 1.150)
FRC,Scan Trimmed,Central,Day 12,n=18,17 Number Analyzed 18 participants 17 participants
1.027
(0.917 to 1.151)
1.052
(0.998 to 1.108)
FRC,Scan Trimmed,Central,Day 28,n=16,19 Number Analyzed 16 participants 19 participants
1.048
(0.928 to 1.183)
1.045
(0.996 to 1.096)
FRC,Scan Trimmed,Distal,Day 12,n=18,17 Number Analyzed 18 participants 17 participants
0.970
(0.859 to 1.096)
1.029
(0.891 to 1.187)
FRC,Scan Trimmed,Distal,Day 28,n=16,19 Number Analyzed 16 participants 19 participants
0.980
(0.844 to 1.138)
1.037
(0.945 to 1.138)
FRC,Scan Trimmed,Total,Day 12,n=18,17 Number Analyzed 18 participants 17 participants
1.023
(0.914 to 1.144)
1.046
(0.989 to 1.106)
FRC,Scan Trimmed,Total,Day 28,n=16,19 Number Analyzed 16 participants 19 participants
1.041
(0.923 to 1.175)
1.042
(0.994 to 1.091)
TLC, Scan Trimmed,Upper,Day 12,n=20,18 Number Analyzed 20 participants 18 participants
0.963
(0.904 to 1.026)
0.982
(0.870 to 1.109)
TLC, Scan Trimmed,Upper,Day 28,n=18,20 Number Analyzed 18 participants 20 participants
0.939
(0.863 to 1.022)
0.945
(0.865 to 1.033)
TLC, Scan Trimmed,Lower,Day 12,n=20,18 Number Analyzed 20 participants 18 participants
0.996
(0.924 to 1.074)
0.982
(0.880 to 1.096)
TLC, Scan Trimmed,Lower,Day 28,n=18,20 Number Analyzed 18 participants 20 participants
0.958
(0.852 to 1.078)
0.925
(0.848 to 1.009)
TLC, Scan Trimmed,Central,Day 12,n=20,18 Number Analyzed 20 participants 18 participants
1.011
(0.981 to 1.042)
1.029
(1.000 to 1.058)
TLC, Scan Trimmed,Central,Day 28,n=18,20 Number Analyzed 18 participants 20 participants
1.013
(0.979 to 1.048)
1.006
(0.984 to 1.028)
TLC, Scan Trimmed,Distal,Day 12,n=20,18 Number Analyzed 20 participants 18 participants
0.979
(0.917 to 1.045)
0.981
(0.876 to 1.098)
TLC, Scan Trimmed,Distal,Day 28,n=18,20 Number Analyzed 18 participants 20 participants
0.948
(0.864 to 1.040)
0.934
(0.860 to 1.015)
TLC, Scan Trimmed,Total,Day 12,n=20,18 Number Analyzed 20 participants 18 participants
1.004
(0.971 to 1.037)
1.020
(0.982 to 1.060)
TLC, Scan Trimmed,Total,Day 28,n=18,20 Number Analyzed 18 participants 20 participants
1.001
(0.968 to 1.035)
0.990
(0.967 to 1.014)
FRC,Untrimmed,Upper,Day 12,n= 18,17 Number Analyzed 18 participants 17 participants
0.967
(0.722 to 1.296)
1.050
(0.842 to 1.309)
FRC,Untrimmed,Upper, Day 28,n=16,19 Number Analyzed 16 participants 19 participants
1.027
(0.699 to 1.507)
1.066
(0.888 to 1.279)
FRC,Untrimmed,Lower, Day 12,n=17,17 Number Analyzed 17 participants 17 participants
1.055
(0.786 to 1.415)
1.026
(0.781 to 1.346)
FRC,Untrimmed, Lower, Day 28,n=16,19 Number Analyzed 16 participants 19 participants
0.991
(0.779 to 1.261)
1.077
(0.886 to 1.308)
FRC,Untrimmed,Central, Day 12,n=18,17 Number Analyzed 18 participants 17 participants
1.035
(0.928 to 1.153)
1.059
(1.008 to 1.113)
FRC,Untrimmed,Central, Day 28,n=16,19 Number Analyzed 16 participants 19 participants
1.054
(0.935 to 1.188)
1.048
(0.994 to 1.10)
FRC,Untrimmed,Distal, Day 12,n=18,17 Number Analyzed 18 participants 17 participants
0.926
(0.729 to 1.177)
1.037
(0.820 to 1.313)
FRC,Untrimmed,Distal, Day 28,n=16,19 Number Analyzed 16 participants 19 participants
0.981
(0.752 to 1.279)
1.071
(0.892 to 1.285)
FRC,Untrimmed,Total, Day 12,n=18,17 Number Analyzed 18 participants 17 participants
1.025
(0.913 to 1.151)
1.050
(0.983 to 1.122)
FRC,Untrimmed,Total, Day 28,n=16,19 Number Analyzed 16 participants 19 participants
1.045
(0.913 to 1.195)
1.046
(0.988 to 1.107)
TLC,Untrimmed,Upper,Day 12,n= 20,18 Number Analyzed 20 participants 18 participants
0.961
(0.853 to 1.082)
0.959
(0.807 to 1.139)
TLC,Untrimmed,Upper, Day 28,n=18,20 Number Analyzed 18 participants 20 participants
0.906
(0.818 to 1.003)
0.923
(0.815 to 1.045)
TLC,Untrimmed,Lower, Day 12,n=20,18 Number Analyzed 20 participants 18 participants
1.035
(0.907 to 1.182)
0.938
(0.804 to 1.095)
TLC,Untrimmed, Lower, Day 28,n=18,20 Number Analyzed 18 participants 20 participants
0.933
(0.766 to 1.138)
0.916
(0.820 to 1.022)
TLC,Untrimmed,Central, Day 12,n=20,18 Number Analyzed 20 participants 18 participants
1.012
(0.985 to 1.040)
1.027
(0.998 to 1.057)
TLC,Untrimmed,Central, Day 28,n=18,20 Number Analyzed 18 participants 20 participants
1.010
(0.974 to 1.047)
1.002
(0.979 to 1.026)
TLC,Untrimmed,Distal, Day 12,n=20,18 Number Analyzed 20 participants 18 participants
0.996
(0.882 to 1.124)
0.946
(0.807 to 1.110)
TLC,Untrimmed,Distal, Day 28,n=18,20 Number Analyzed 18 participants 20 participants
0.922
(0.803 to 1.057)
0.918
(0.824 to 1.022)
TLC,Untrimmed,Total, Day 12,n=20,18 Number Analyzed 20 participants 18 participants
1.000
(0.970 to 1.031)
1.009
(0.962 to 1.059)
TLC,Untrimmed,Total, Day 28,n=18,20 Number Analyzed 18 participants 20 participants
0.993
(0.950 to 1.038)
0.982
(0.957 to 1.008)
7.Secondary Outcome
Title Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Regions at Day 28
Hide Description siVaw is a measure of the volume in an individual's airway corrected for their lobar volume derived from the high resolution computed tomography (HRCT). It was measured at FRC and TLC. Data was collected at longitudinal time points (Untrimmed data): Baseline (Screening), Day 12 & Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For Untrimmed data and SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (represented by n=X1, X2 in the category title). This table presents the D12D28 scan trim pair data only.
Time Frame Baseline (Day 12) and Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
Arm/Group Title All Placebo All NEMI
Hide Arm/Group Description:
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS or ELLIPTA dry powder inhaler (DPI).
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
Overall Number of Participants Analyzed 22 22
Geometric Mean (95% Confidence Interval)
Unit of Measure: Milliliters per Liter
FRC,Scan Trimmed,Upper,Day 28,n=16,18 Number Analyzed 16 participants 18 participants
0.996
(0.917 to 1.082)
0.986
(0.907 to 1.072)
FRC,Scan Trimmed,Lower,Day 28,n=16,18 Number Analyzed 16 participants 18 participants
0.948
(0.862 to 1.042)
1.025
(0.909 to 1.155)
FRC,Scan Trimmed,Central,Day 28,n=16,18 Number Analyzed 16 participants 18 participants
0.997
(0.955 to 1.042)
1.014
(0.955 to 1.076)
FRC,Scan Trimmed,Distal,Day 28,n=16,18 Number Analyzed 16 participants 18 participants
0.977
(0.898 to 1.063)
0.996
(0.914 to 1.085)
FRC,Scan Trimmed,Total,Day 28,n=16, 18 Number Analyzed 16 participants 18 participants
0.997
(0.952 to 1.043)
1.012
(0.953 to 1.075)
TLC,Scan Trimmed,Upper,Day 28,n=17,19 Number Analyzed 17 participants 19 participants
0.973
(0.884 to 1.070)
0.970
(0.930 to 1.012)
TLC,Scan Trimmed,Lower,Day 28,n=17, 19 Number Analyzed 17 participants 19 participants
0.954
(0.865 to 1.051)
0.952
(0.893 to 1.014)
TLC,Scan Trimmed,Central,Day 28,n=17,19 Number Analyzed 17 participants 19 participants
1.009
(0.979 to 1.040)
0.977
(0.943 to 1.012)
TLC,Scan Trimmed,Distal,Day 28,n=17,19 Number Analyzed 17 participants 19 participants
0.967
(0.880 to 1.063)
0.960
(0.917 to 1.004)
TLC,Scan Trimmed,Total,Day 28,n=17,19 Number Analyzed 17 participants 19 participants
1.003
(0.965 to 1.042)
0.972
(0.939 to 1.006)
8.Secondary Outcome
Title Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes
Hide Description iVaw was measured at FRC and TLC. Data was collected at longitudinal time points (Untrimmed data): Screening, Day 12 & Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For Untrimmed data and SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (n=X1, X2 in the category title). This table presents the untrimmed data (in rows with categories containing untrimmed), SCRD12 scan trim pair data (in rows with categories containing Scan Trimmed and Day 12) and SCRD28 scan trim pair data (in rows with categories containing Scan Trimmed and Day 28) only.
Time Frame Baseline (Screening) and Days 12 and 28
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
Arm/Group Title All Placebo All NEMI
Hide Arm/Group Description:
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS or ELLIPTA dry powder inhaler (DPI).
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
Overall Number of Participants Analyzed 22 22
Geometric Mean (95% Confidence Interval)
Unit of Measure: Milliliters
FRC,Scan Trimmed,Right Upper,Day 12,n=18,17 Number Analyzed 18 participants 17 participants
1.007
(0.847 to 1.197)
1.044
(0.879 to 1.240)
FRC,Scan Trimmed,Right Upper,Day 28,n=16,19 Number Analyzed 16 participants 19 participants
1.016
(0.826 to 1.249)
1.037
(0.931 to 1.155)
FRC,Scan Trimmed,Left Upper,Day 12,n=18,17 Number Analyzed 18 participants 17 participants
0.965
(0.783 to 1.190)
0.987
(0.830 to 1.173)
FRC,Scan Trimmed,Left Upper,Day 28,n=16,19 Number Analyzed 16 participants 19 participants
0.998
(0.767 to 1.299)
1.062
(0.919 to 1.227)
FRC,Right Middle,Day 12,n=18,17 Number Analyzed 18 participants 17 participants
1.129
(0.803 to 1.588)
1.014
(0.874 to 1.176)
FRC,Scan Trimmed,Right Middle,Day 28,n=16,19 Number Analyzed 16 participants 19 participants
0.950
(0.739 to 1.221)
1.018
(0.881 to 1.176)
FRC,Right Lower,Day 12,n=17,17 Number Analyzed 17 participants 17 participants
1.046
(0.884 to 1.237)
1.005
(0.824 to 1.225)
FRC,Scan Trimmed,Right Lower,Day 28,n=16,19 Number Analyzed 16 participants 19 participants
1.042
(0.879 to 1.235)
1.025
(0.889 to 1.181)
FRC,Left Lower,Day 12,n=17,17 Number Analyzed 17 participants 17 participants
1.003
(0.855 to 1.178)
1.010
(0.832 to 1.226)
FRC,Scan Trimmed,Left Lower,Day 28,n=16,19 Number Analyzed 16 participants 19 participants
0.971
(0.836 to 1.127)
1.029
(0.920 to 1.151)
TLC,Scan Trimmed,Right Upper,Day 12,n=20,18 Number Analyzed 20 participants 18 participants
0.976
(0.903 to 1.054)
0.982
(0.864 to 1.117)
TLC,Scan Trimmed,Right Upper,Day 28,n=18,20 Number Analyzed 18 participants 20 participants
0.941
(0.858 to 1.032)
0.946
(0.849 to 1.054)
TLC,Scan Trimmed,Left Upper,Day 12,n=20,18 Number Analyzed 20 participants 18 participants
0.957
(0.897 to 1.020)
0.958
(0.840 to 1.093)
TLC,Scan Trimmed,Left Upper,Day 28,n=18,20 Number Analyzed 18 participants 20 participants
0.928
(0.849 to 1.015)
0.938
(0.857 to 1.025)
TLC,Scan Trimmed,Right Middle,Day 12,n=19,18 Number Analyzed 19 participants 18 participants
0.882
(0.810 to 0.961)
0.988
(0.881 to 1.108)
TLC,Scan Trimmed,Right Middle,Day 28,n=18,20 Number Analyzed 18 participants 20 participants
0.873
(0.742 to 1.027)
0.895
(0.811 to 0.987)
TLC,Scan Trimmed,Right Lower,Day 12,n=20,18 Number Analyzed 20 participants 18 participants
1.083
(0.966 to 1.214)
0.937
(0.828 to 1.061)
TLC,Scan Trimmed,Right Lower,Day 28,n=18,20 Number Analyzed 18 participants 20 participants
0.967
(0.860 to 1.088)
0.877
(0.782 to 0.983)
TLC,Scan Trimmed,Left Lower,Day 12,n=20,18 Number Analyzed 20 participants 18 participants
0.981
(0.922 to 1.044)
0.981
(0.850 to 1.131)
TLC,Scan Trimmed,Left Lower,Day 28,n=18,20 Number Analyzed 18 participants 20 participants
0.939
(0.832 to 1.060)
0.923
(0.843 to 1.010)
FRC,Untrimmed,Right Upper,Day 12,n= 18,17 Number Analyzed 18 participants 17 participants
0.886
(0.652 to 1.203)
1.095
(0.858 to 1.396)
FRC,Untrimmed,Right Upper, Day 28,n=16,19 Number Analyzed 16 participants 19 participants
0.990
(0.703 to 1.393)
1.083
(0.923 to 1.272)
FRC,Untrimmed,Left Upper, Day 12,n=18,17 Number Analyzed 18 participants 17 participants
0.996
(0.668 to 1.485)
0.950
(0.696 to 1.297)
FRC,Untrimmed,Left Upper, Day 28,n=16,19 Number Analyzed 16 participants 19 participants
1.071
(0.656 to 1.749)
1.074
(0.798 to 1.444)
FRC,Untrimmed,Right Middle, Day 12,n=18,17 Number Analyzed 18 participants 17 participants
1.167
(0.633 to 2.149)
1.157
(0.840 to 1.595)
FRC,Untrimmed,Right Middle, Day 28,n=16,19 Number Analyzed 16 participants 19 participants
0.991
(0.629 to 1.562)
1.155
(0.819 to 1.631)
FRC,Untrimmed,Right Lower, Day 12,n=17,17 Number Analyzed 17 participants 17 participants
1.262
(0.791 to 2.015)
0.990
(0.703 to 1.392)
FRC,Untrimmed,Right Lower, Day 28,n=16,19 Number Analyzed 16 participants 19 participants
1.253
(0.832 to 1.885)
1.014
(0.784 to 1.311)
FRC,Untrimmed,Left Lower, Day 12,n=17,17 Number Analyzed 17 participants 17 participants
0.959
(0.714 to 1.287)
0.981
(0.655 to 1.469)
FRC,Untrimmed,Left Lower, Day 28,n=16,19 Number Analyzed 16 participants 19 participants
0.813
(0.571 to 1.157)
1.107
(0.882 to 1.389)
TLC,Untrimmed,Right Upper,Day 12,n=20,18 Number Analyzed 20 participants 18 participants
0.960
(0.839 to 1.098)
0.984
(0.822 to 1.178)
TLC,Untrimmed,Right Upper, Day 28,n=18,20 Number Analyzed 18 participants 20 participants
0.874
(0.754 to 1.012)
0.923
(0.797 to 1.069)
TLC,Untrimmed,Left Upper, Day 12,n=20,18 Number Analyzed 20 participants 18 participants
0.958
(0.853 to 1.075)
0.932
(0.779 to 1.116)
TLC,Untrimmed,Left Upper, Day 28,n=18,20 Number Analyzed 18 participants 20 participants
0.942
(0.850 to 1.043)
0.914
(0.800 to 1.045)
TLC,Untrimmed,Right Middle, Day 12,n=19,18 Number Analyzed 19 participants 18 participants
0.872
(0.724 to 1.050)
0.952
(0.806 to 1.124)
TLC,Untrimmed,Right Middle, Day 28,n=18,20 Number Analyzed 18 participants 20 participants
0.622
(0.367 to 1.053)
0.886
(0.780 to 1.007)
TLC,Untrimmed,Right Lower, Day 12,n=20,18 Number Analyzed 20 participants 18 participants
1.162
(0.914 to 1.476)
0.871
(0.721 to 1.053)
TLC,Untrimmed,Right Lower, Day 28,n=18,20 Number Analyzed 18 participants 20 participants
0.963
(0.795 to 1.166)
0.843
(0.725 to 0.981)
TLC,Untrimmed,Left Lower, Day 12,n=20,18 Number Analyzed 20 participants 18 participants
0.996
(0.888 to 1.117)
0.967
(0.797 to 1.172)
TLC,Untrimmed,Left Lower, Day 28,n=18,20 Number Analyzed 18 participants 20 participants
0.881
(0.675 to 1.149)
0.940
(0.828 to 1.066)
9.Secondary Outcome
Title Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Lobes at Day 28
Hide Description iVaw is a measure of the volume in an individual's airway derived from the HRCT. It was measured at FRC and TLC. Data was collected at longitudinal time points (Untrimmed data): Screening, Day 12 & Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For Untrimmed data and SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (represented by n=X1, X2 in the category title). This table presents the D12D28 scan trim pair data only.
Time Frame Baseline (Day 12) and Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
Arm/Group Title All Placebo All NEMI
Hide Arm/Group Description:
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS or ELLIPTA dry powder inhaler (DPI).
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
Overall Number of Participants Analyzed 22 22
Geometric Mean (95% Confidence Interval)
Unit of Measure: Milliliters
FRC,Scan Trimmed,Right Upper,Day 28,n=16,18 Number Analyzed 16 participants 18 participants
0.995
(0.918 to 1.078)
0.977
(0.880 to 1.084)
FRC,Scan Trimmed,Left Upper,Day 28,n=16,18 Number Analyzed 16 participants 18 participants
0.973
(0.891 to 1.063)
1.016
(0.898 to 1.151)
FRC,Scan Trimmed,Right Middle,Day 28,n=16,18 Number Analyzed 16 participants 18 participants
0.958
(0.842 to 1.090)
0.943
(0.838 to 1.061)
FRC,Scan Trimmed,Right Lower,Day 28,n=16,18 Number Analyzed 16 participants 18 participants
0.918
(0.821 to 1.025)
1.008
(0.855 to 1.188)
FRC,Scan Trimmed,Left Lower,Day 28,n=16,18 Number Analyzed 16 participants 18 participants
0.943
(0.852 to 1.045)
1.024
(0.877 to 1.196)
TLC,Scan Trimmed,Right Upper,Day 28,n=17,19 Number Analyzed 17 participants 19 participants
0.963
(0.875 to 1.060)
0.966
(0.936 to 0.997)
TLC,Scan Trimmed,Left Upper,Day 28,n=17,19 Number Analyzed 17 participants 19 participants
0.976
(0.885 to 1.076)
0.996
(0.942 to 1.052)
TLC,Right Middle,Day 28,n=17,19 Number Analyzed 17 participants 19 participants
0.784
(0.571 to 1.077)
0.904
(0.841 to 0.971)
TLC,Scan Trimmed,Right Lower,Day 28,n=17,19 Number Analyzed 17 participants 19 participants
0.926
(0.826 to 1.038)
0.935
(0.876 to 0.997)
TLC,Scan Trimmed,Left Lower,Day 28,n=17,19 Number Analyzed 17 participants 19 participants
0.928
(0.833 to 1.035)
0.951
(0.855 to 1.057)
10.Secondary Outcome
Title Change From Baseline in iVaw at FRC and TLC for Individual Regions
Hide Description iVaw was measured at FRC and TLC. Data was collected at longitudinal time points (Untrimmed data): Screening, Day 12 & Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For Untrimmed data and SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (n=X1, X2 in the category title). This table presents the untrimmed data (in rows with categories containing untrimmed), SCRD12 scan trim pair data (in rows with categories containing Scan Trimmed and Day 12) and SCRD28 scan trim pair data (in rows with categories containing Scan Trimmed and Day 28) only.
Time Frame Baseline (Screening) and Days 12 and 28
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
Arm/Group Title All Placebo All NEMI
Hide Arm/Group Description:
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS or ELLIPTA dry powder inhaler (DPI).
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
Overall Number of Participants Analyzed 22 22
Geometric Mean (95% Confidence Interval)
Unit of Measure: Milliliters
FRC,Scan Trimmed,Upper,Day 12,n=18,17 Number Analyzed 18 participants 17 participants
0.987
(0.827 to 1.178)
1.021
(0.869 to 1.200)
FRC,Scan Trimmed,Upper,Day 28,n=16,19 Number Analyzed 16 participants 19 participants
0.999
(0.800 to 1.246)
1.039
(0.927 to 1.166)
FRC,Scan Trimmed,Lower,Day 12,n=17,17 Number Analyzed 17 participants 17 participants
1.009
(0.864 to 1.178)
1.017
(0.863 to 1.199)
FRC,Scan Trimmed,Lower,Day 28,n=16,19 Number Analyzed 16 participants 19 participants
0.993
(0.862 to 1.142)
1.018
(0.899 to 1.152)
FRC,Scan Trimmed,Central,Day 12,n=18,17 Number Analyzed 18 participants 17 participants
1.025
(0.925 to 1.136)
1.040
(0.985 to 1.097)
FRC,Scan Trimmed,Central,Day 28,n=16,19 Number Analyzed 16 participants 19 participants
1.040
(0.936 to 1.155)
1.040
(0.974 to 1.110)
FRC,Scan Trimmed,Distal,Day 12,n=18,17 Number Analyzed 18 participants 17 participants
0.969
(0.847 to 1.107)
1.017
(0.866 to 1.194)
FRC,Scan Trimmed,Distal,Day 28,n=16,19 Number Analyzed 16 participants 19 participants
0.973
(0.834 to 1.135)
1.032
(0.921 to 1.157)
FRC,Scan Trimmed,Total,Day 12,n=18,17 Number Analyzed 18 participants 17 participants
1.021
(0.920 to 1.132)
1.034
(0.970 to 1.101)
FRC,Scan Trimmed,Total,Day 28,n=16,19 Number Analyzed 16 participants 19 participants
1.034
(0.927 to 1.153)
1.037
(0.970 to 1.108)
TLC,Scan Trimmed,Upper,Day 12,n=20,18 Number Analyzed 20 participants 18 participants
0.959
(0.899 to 1.023)
0.973
(0.860 to 1.101)
TLC,Scan Trimmed,Upper,Day 28,n=18,20 Number Analyzed 18 participants 20 participants
0.930
(0.851 to 1.015)
0.935
(0.853 to 1.024)
TLC,Scan Trimmed,Lower,Day 12,n=20,18 Number Analyzed 20 participants 18 participants
1.017
(0.945 to 1.094)
0.960
(0.858 to 1.074)
TLC,Scan Trimmed,Lower,Day 28,n=18,20 Number Analyzed 18 participants 20 participants
0.958
(0.846 to 1.084)
0.902
(0.823 to 0.989)
TLC,Scan Trimmed,Central,Day 12,n=20,18 Number Analyzed 20 participants 18 participants
1.019
(0.998 to 1.040)
1.013
(0.988 to 1.040)
TLC,Scan Trimmed,Central,Day 28,n=18,20 Number Analyzed 18 participants 20 participants
1.006
(0.984 to 1.028)
0.989
(0.965 to 1.013)
TLC,Scan Trimmed,Distal,Day 12,n=20,18 Number Analyzed 20 participants 18 participants
0.986
(0.924 to 1.053)
0.966
(0.862 to 1.083)
TLC,Scan Trimmed,Distal,Day 28,n=18,20 Number Analyzed 18 participants 20 participants
0.941
(0.854 to 1.038)
0.918
(0.842 to 1.002)
TLC,Scan Trimmed,Total,Day 12,n=20,18 Number Analyzed 20 participants 18 participants
1.011
(0.985 to 1.038)
1.005
(0.968 to 1.043)
TLC,Scan Trimmed,Total,Day 28,n=18,20 Number Analyzed 18 participants 20 participants
0.994
(0.967 to 1.022)
0.973
(0.947 to 1.000)
FRC,Untrimmed,Upper,Day 12,n= 18,17 Number Analyzed 18 participants 17 participants
0.959
(0.704 to 1.305)
1.047
(0.815 to 1.345)
FRC,Untrimmed,Upper, Day 28,n=16,19 Number Analyzed 16 participants 19 participants
1.014
(0.685 to 1.499)
1.076
(0.876 to 1.323)
FRC,Untrimmed,Lower, Day 12,n=17,17 Number Analyzed 17 participants 17 participants
1.060
(0.761 to 1.478)
1.004
(0.741 to 1.359)
FRC,Untrimmed, Lower, Day 28,n=16,19 Number Analyzed 16 participants 19 participants
0.993
(0.750 to 1.315)
1.052
(0.840 to 1.319)
FRC,Untrimmed,Central, Day 12,n=18,17 Number Analyzed 18 participants 17 participants
1.033
(0.920 to 1.160)
1.047
(0.967 to 1.134)
FRC,Untrimmed,Central, Day 28,n=16,19 Number Analyzed 16 participants 19 participants
1.046
(0.926 to 1.182)
1.043
(0.961 to 1.133)
FRC,Untrimmed,Distal, Day 12,n=18,17 Number Analyzed 18 participants 17 participants
0.924
(0.709 to 1.205)
1.025
(0.788 to 1.333)
FRC,Untrimmed,Distal, Day 28,n=16,19 Number Analyzed 16 participants 19 participants
0.974
(0.735 to 1.290)
1.066
(0.865 to 1.313)
FRC,Untrimmed,Total, Day 12,n=18,17 Number Analyzed 18 participants 17 participants
1.023
(0.900 to 1.163)
1.038
(0.941 to 1.145)
FRC,Untrimmed,Total, Day 28,n=16,19 Number Analyzed 16 participants 19 participants
1.037
(0.898 to 1.198)
1.041
(0.953 to 1.137)
TLC,Untrimmed,Upper,Day 12,n= 20,18 Number Analyzed 20 participants 18 participants
0.957
(0.841 to 1.089)
0.950
(0.800 to 1.129)
TLC,Untrimmed,Upper, Day 28,n=18,20 Number Analyzed 18 participants 20 participants
0.897
(0.805 to 0.998)
0.912
(0.804 to 1.035)
TLC,Untrimmed,Lower, Day 12,n=20,18 Number Analyzed 20 participants 18 participants
1.057
(0.915 to 1.220)
0.917
(0.783 to 1.074)
TLC,Untrimmed, Lower, Day 28,n=18,20 Number Analyzed 18 participants 20 participants
0.933
(0.759 to 1.147)
0.893
(0.795 to 1.002)
TLC,Untrimmed,Central, Day 12,n=20,18 Number Analyzed 20 participants 18 participants
1.020
(0.997 to 1.043)
1.012
(0.984 to 1.041)
TLC,Untrimmed,Central, Day 28,n=18,20 Number Analyzed 18 participants 20 participants
1.003
(0.976 to 1.032)
0.985
(0.959 to 1.012)
TLC,Untrimmed,Distal, Day 12,n=20,18 Number Analyzed 20 participants 18 participants
1.003
(0.881 to 1.143)
0.932
(0.795 to 1.093)
TLC,Untrimmed,Distal, Day 28,n=18,20 Number Analyzed 18 participants 20 participants
0.916
(0.793 to 1.056)
0.902
(0.808 to 1.008)
TLC,Untrimmed,Total, Day 12,n=20,18 Number Analyzed 20 participants 18 participants
1.008
(0.976 to 1.040)
0.994
(0.949 to 1.042)
TLC,Untrimmed,Total, Day 28,n=18,20 Number Analyzed 18 participants 20 participants
0.986
(0.945 to 1.030)
0.965
(0.936 to 0.995)
11.Secondary Outcome
Title Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Regions at Day 28
Hide Description iVaw is a measure of the volume in an individual's airway derived from the HRCT. It was measured at FRC and TLC. Data was collected at longitudinal time points (Untrimmed data): Screening, Day 12 & Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For Untrimmed data and SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (represented by n=X1, X2 in the category title). This table presents the D12D28 scan trim pair data only.
Time Frame Baseline (Day 12) and Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
Arm/Group Title All Placebo All NEMI
Hide Arm/Group Description:
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS or ELLIPTA dry powder inhaler (DPI).
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
Overall Number of Participants Analyzed 22 22
Geometric Mean (95% Confidence Interval)
Unit of Measure: Milliliters
FRC,Scan Trimmed,Upper,Day 28,n=16,18 Number Analyzed 16 participants 18 participants
0.988
(0.912 to 1.070)
0.985
(0.891 to 1.089)
FRC,Scan Trimmed,Lower,Day 28,n=16,18 Number Analyzed 16 participants 18 participants
0.934
(0.847 to 1.030)
1.010
(0.876 to 1.165)
FRC,Scan Trimmed,Central,Day 28,n=16,18 Number Analyzed 16 participants 18 participants
0.985
(0.953 to 1.019)
1.008
(0.942 to 1.078)
FRC,Scan Trimmed,Distal,Day 28,n=16,18 Number Analyzed 16 participants 18 participants
0.966
(0.891 to 1.047)
0.990
(0.890 to 1.102)
FRC,Scan Trimmed,Total,Day 28,n=16,18 Number Analyzed 16 participants 18 participants
0.985
(0.949 to 1.022)
1.006
(0.938 to 1.080)
TLC,Scan Trimmed,Upper,Day 28,n=17,19 Number Analyzed 17 participants 19 participants
0.968
(0.877 to 1.067)
0.968
(0.932 to 1.005)
TLC,Scan Trimmed,Lower,Day 28,n=17,19 Number Analyzed 17 participants 19 participants
0.933
(0.840 to 1.037)
0.942
(0.879 to 1.010)
TLC,Scan Trimmed,Central,Day 28,n=17,19 Number Analyzed 17 participants 19 participants
0.996
(0.968 to 1.024)
0.972
(0.940 to 1.004)
TLC,Scan Trimmed,Distal,Day 28,n=17,19 Number Analyzed 17 participants 19 participants
0.954
(0.865 to 1.052)
0.954
(0.912 to 0.998)
TLC,Scan Trimmed,Total,Day 28,n=17,19 Number Analyzed 17 participants 19 participants
0.989
(0.952 to 1.028)
0.966
(0.936 to 0.998)
12.Secondary Outcome
Title Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes
Hide Description iRaw is a measure of the resistance in an individual's airway derived from HRCT. It was measured at FRC and TLC. Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (represented by n=X1, X2 in the category title). • This table presents the SCRD12 scan trim pair data (in rows with categories containing Scan Trimmed and Day 12) and SCRD28 scan trim pair data (in rows with categories containing Scan Trimmed and Day 28) only.
Time Frame Baseline (Screening) and Days 12 and 28
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
Arm/Group Title All Placebo All NEMI
Hide Arm/Group Description:
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS or ELLIPTA dry powder inhaler (DPI).
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
Overall Number of Participants Analyzed 22 22
Geometric Mean (95% Confidence Interval)
Unit of Measure: Kilopascal* seconds per liter (kPa*s/L)
FRC,Scan Trimmed,Right Upper,Day 12,n=18,17 Number Analyzed 18 participants 17 participants
1.129
(0.641 to 1.991)
0.876
(0.477 to 1.606)
FRC,Scan Trimmed,Right Upper,Day 28,n=16,19 Number Analyzed 16 participants 19 participants
1.213
(0.569 to 2.586)
0.884
(0.582 to 1.343)
FRC,Scan Trimmed,Left Upper,Day 12,n=18,17 Number Analyzed 18 participants 17 participants
1.058
(0.631 to 1.774)
0.951
(0.592 to 1.530)
FRC,Scan Trimmed,Left Upper,Day 28,n=16,19 Number Analyzed 16 participants 19 participants
1.151
(0.582 to 2.273)
0.681
(0.438 to 1.060)
FRC,Scan Trimmed,Right Middle,Day 12,n=18,17 Number Analyzed 18 participants 17 participants
0.559
(0.198 to 1.576)
0.970
(0.578 to 1.627)
FRC,Scan Trimmed,Right Middle,Day 28,n=16,19 Number Analyzed 16 participants 19 participants
1.420
(0.573 to 3.518)
1.275
(0.732 to 2.219)
FRC,Scan Trimmed,Right Lower,Day 12,n=17,17 Number Analyzed 17 participants 17 participants
0.903
(0.352 to 2.314)
1.149
(0.714 to 1.849)
FRC,Scan Trimmed,Right Lower,Day 28,n=16,19 Number Analyzed 16 participants 19 participants
0.681
(0.251 to 1.850)
0.935
(0.512 to 1.706)
FRC,Scan Trimmed,Left Lower,Day 12,n=17,17 Number Analyzed 17 participants 17 participants
1.084
(0.642 to 1.832)
0.902
(0.378 to 2.157)
FRC,Scan Trimmed,Left Lower,Day 28,n=16,19 Number Analyzed 16 participants 19 participants
1.576
(0.656 to 3.785)
0.904
(0.642 to 1.274)
TLC,Scan Trimmed,Right Upper,Day 12,n=20,18 Number Analyzed 20 participants 18 participants
1.058
(0.820 to 1.366)
1.057
(0.739 to 1.511)
TLC,Scan Trimmed,Right Upper,Day 28,n=18,20 Number Analyzed 18 participants 20 participants
1.307
(0.994 to 1.718)
1.292
(0.951 to 1.755)
TLC,Scan Trimmed,Left Upper,Day 12,n=20,18 Number Analyzed 20 participants 18 participants
1.129
(0.938 to 1.360)
1.075
(0.662 to 1.747)
TLC,Scan Trimmed,Left Upper,Day 28,n=18,20 Number Analyzed 18 participants 20 participants
1.212
(0.957 to 1.534)
1.160
(0.851 to 1.580)
TLC,Scan Trimmed,Right Middle,Day 12,n=19,18 Number Analyzed 19 participants 18 participants
1.190
(0.823 to 1.720)
1.148
(0.747 to 1.763)
TLC,Scan Trimmed,Right Middle,Day 28,n=18,20 Number Analyzed 18 participants 20 participants
1.749
(0.981 to 3.117)
1.583
(1.002 to 2.502)
TLC,Scan Trimmed,Right Lower,Day 12,n=20,18 Number Analyzed 20 participants 18 participants
0.727
(0.484 to 1.092)
1.325
(0.860 to 2.041)
TLC,Scan Trimmed,Right Lower,Day 28,n=18,20 Number Analyzed 18 participants 20 participants
1.143
(0.797 to 1.639)
1.463
(1.077 to 1.988)
TLC,Scan Trimmed,Left Lower,Day 12,n=20,18 Number Analyzed 20 participants 18 participants
1.003
(0.798 to 1.260)
1.144
(0.714 to 1.833)
TLC,Scan Trimmed,Left Lower,Day 28,n=18,20 Number Analyzed 18 participants 20 participants
1.259
(0.741 to 2.140)
1.213
(0.907 to 1.623)
13.Secondary Outcome
Title Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Lobes at Day 28
Hide Description iRaw is a measure of the resistance in an individual's airway derived from HRCT. It was measured at FRC and TLC. Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (represented by n=X1, X2 in the category title). This table presents the D12D28 scan trim pair data only.
Time Frame Baseline (Day 12) and Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
Arm/Group Title All Placebo All NEMI
Hide Arm/Group Description:
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS or ELLIPTA dry powder inhaler (DPI).
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
Overall Number of Participants Analyzed 22 22
Geometric Mean (95% Confidence Interval)
Unit of Measure: kPa*s/L
FRC,Scan Trimmed,Right Upper,Day 28,n=16,18 Number Analyzed 16 participants 18 participants
1.082
(0.714 to 1.641)
1.152
(0.819 to 1.620)
FRC,Scan Trimmed,Left Upper,Day 28,n=16,18 Number Analyzed 16 participants 18 participants
1.266
(0.892 to 1.798)
1.008
(0.641 to 1.587)
FRC,Scan Trimmed,Right Middle,Day 28,n=16,18 Number Analyzed 16 participants 18 participants
1.149
(0.709 to 1.862)
1.477
(0.927 to 2.355)
FRC,Scan Trimmed,Right Lower,Day 28,n=16,18 Number Analyzed 16 participants 18 participants
1.269
(0.840 to 1.916)
1.276
(0.693 to 2.350)
FRC,Scan Trimmed,Left Lower,Day 28,n=16,18 Number Analyzed 16 participants 18 participants
1.768
(0.902 to 3.465)
1.185
(0.759 to 1.850)
TLC,Scan Trimmed,Right Upper,Day 28,n=17,19 Number Analyzed 17 participants 19 participants
1.133
(0.798 to 1.608)
1.143
(0.995 to 1.314)
TLC,Scan Trimmed,Left Upper,Day 28,n=17,19 Number Analyzed 17 participants 19 participants
1.000
(0.732 to 1.367)
1.093
(0.927 to 1.288)
TLC,Scan Trimmed,Right Middle,Day 28,n=17,19 Number Analyzed 17 participants 19 participants
1.971
(0.962 to 4.039)
1.537
(1.055 to 2.238)
TLC,Scan Trimmed,Right Lower,Day 28,n=17,19 Number Analyzed 17 participants 19 participants
1.408
(0.901 to 2.199)
1.073
(0.779 to 1.478)
TLC,Scan Trimmed,Left Lower,Day 28,n=17,19 Number Analyzed 17 participants 19 participants
1.486
(0.983 to 2.248)
1.056
(0.691 to 1.615)
14.Secondary Outcome
Title Change From Baseline in iRaw at FRC and TLC for Individual Regions
Hide Description iRaw is a measure of the resistance in an individual's airway derived from HRCT. It was measured at FRC and TLC. Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (n=X1, X2 in the category title). This table presents the SCRD12 scan trim pair data (in rows with categories containing Scan Trimmed and Day 12) and SCRD28 scan trim pair data (in rows with categories containing Scan Trimmed and Day 28) only.
Time Frame Baseline (Screening) and Days 12 and 28
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
Arm/Group Title All Placebo All NEMI
Hide Arm/Group Description:
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS or ELLIPTA dry powder inhaler (DPI).
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
Overall Number of Participants Analyzed 22 22
Geometric Mean (95% Confidence Interval)
Unit of Measure: kPa*s/L
FRC,Scan Trimmed,Upper,Day 12,n=18,17 Number Analyzed 18 participants 17 participants
0.827
(0.448 to 1.526)
0.831
(0.520 to 1.326)
FRC,Scan Trimmed,Upper,Day 28,n=16,19 Number Analyzed 16 participants 19 participants
1.395
(0.682 to 2.851)
0.776
(0.526 to 1.144)
FRC,Scan Trimmed,Lower,Day 12,n=17,17 Number Analyzed 17 participants 17 participants
1.112
(0.553 to 2.236)
1.066
(0.510 to 2.225)
FRC,Scan Trimmed,Lower,Day 28,n=16,19 Number Analyzed 16 participants 19 participants
1.071
(0.515 to 2.230)
0.912
(0.598 to 1.391)
FRC,Scan Trimmed,Central,Day 12,n=18,17 Number Analyzed 18 participants 17 participants
0.932
(0.637 to 1.364)
0.888
(0.729 to 1.082)
FRC,Scan Trimmed,Central,Day 28,n=16,19 Number Analyzed 16 participants 19 participants
0.876
(0.606 to 1.266)
0.871
(0.694 to 1.094)
FRC,Scan Trimmed,Distal,Day 12,n=18,17 Number Analyzed 18 participants 17 participants
1.001
(0.625 to 1.602)
1.098
(0.563 to 2.144)
FRC,Scan Trimmed,Distal,Day 28,n=16,19 Number Analyzed 16 participants 19 participants
1.169
(0.559 to 2.443)
0.857
(0.589 to 1.247)
FRC,Scan Trimmed,Total,Day 12,n=18,17 Number Analyzed 18 participants 17 participants
0.985
(0.673 to 1.441)
0.972
(0.711 to 1.329)
FRC,Scan Trimmed,Total,Day 28,n=16,19 Number Analyzed 16 participants 19 participants
1.045
(0.656 to 1.665)
0.913
(0.701 to 1.190)
TLC,Scan Trimmed,Upper,Day 12,n=20,18 Number Analyzed 20 participants 18 participants
1.142
(0.888 to 1.469)
1.167
(0.727 to 1.872)
TLC,Scan Trimmed,Upper,Day 28,n=18,20 Number Analyzed 18 participants 20 participants
1.540
(1.106 to 2.145)
1.271
(0.956 to 1.690)
TLC,Scan Trimmed,Lower,Day 12,n=20,18 Number Analyzed 20 participants 18 participants
0.860
(0.649 to 1.141)
1.206
(0.835 to 1.741)
TLC,Scan Trimmed,Lower,Day 28,n=18,20 Number Analyzed 18 participants 20 participants
1.142
(0.734 to 1.775)
1.315
(1.004 to 1.723)
TLC,Scan Trimmed,Central,Day 12,n=20,18 Number Analyzed 20 participants 18 participants
0.987
(0.876 to 1.111)
1.005
(0.882 to 1.146)
TLC,Scan Trimmed,Central,Day 28,n=18,20 Number Analyzed 18 participants 20 participants
0.985
(0.914 to 1.061)
1.057
(0.943 to 1.186)
TLC,Scan Trimmed,Distal,Day 12,n=20,18 Number Analyzed 20 participants 18 participants
0.959
(0.726 to 1.268)
1.278
(0.824 to 1.983)
TLC,Scan Trimmed,Distal,Day 28,n=18,20 Number Analyzed 18 participants 20 participants
1.332
(0.869 to 2.040)
1.288
(0.993 to 1.669)
TLC,Scan Trimmed,Total,Day 12,n=20,18 Number Analyzed 20 participants 18 participants
0.993
(0.831 to 1.187)
1.109
(0.853 to 1.443)
TLC,Scan Trimmed,Total,Day 28,n=18,20 Number Analyzed 18 participants 20 participants
1.196
(0.959 to 1.492)
1.202
(0.990 to 1.460)
15.Secondary Outcome
Title Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Regions at Day 28
Hide Description iRaw is a measure of the resistance in an individual's airway derived from HRCT. It was measured at FRC and TLC. Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (represented by n=X1, X2 in the category title). This table presents the D12D28 scan trim pair data only.
Time Frame Baseline (Day 12) and Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
Arm/Group Title All Placebo All NEMI
Hide Arm/Group Description:
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS or ELLIPTA dry powder inhaler (DPI).
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
Overall Number of Participants Analyzed 22 22
Geometric Mean (95% Confidence Interval)
Unit of Measure: kPa*s/L
FRC,Scan Trimmed,Upper,Day 28,n=16,18 Number Analyzed 16 participants 18 participants
1.221
(0.870 to 1.715)
1.266
(0.848 to 1.891)
FRC,Scan Trimmed,Lower,Day 28,n=16,18 Number Analyzed 16 participants 18 participants
1.531
(0.937 to 2.499)
1.278
(0.774 to 2.112)
FRC,Scan Trimmed,Central,Day 28,n=16,18 Number Analyzed 16 participants 18 participants
0.989
(0.873 to 1.121)
0.926
(0.697 to 1.231)
FRC,Scan Trimmed,Distal,Day 28,n=16,18 Number Analyzed 16 participants 18 participants
1.373
(0.986 to 1.912)
1.235
(0.856 to 1.781)
FRC,Scan Trimmed,Total,Day 28,n=16,18 Number Analyzed 16 participants 18 participants
1.157
(0.940 to 1.425)
1.001
(0.714 to 1.402)
TLC,Scan Trimmed,Upper,Day 28,n=17,19 Number Analyzed 17 participants 19 participants
1.473
(0.938 to 2.313)
1.172
(1.052 to 1.306)
TLC,Scan Trimmed,Lower,Day 28,n=17,19 Number Analyzed 17 participants 19 participants
1.422
(0.942 to 2.148)
1.089
(0.816 to 1.454)
TLC,Scan Trimmed,Central,Day 28,n=17,19 Number Analyzed 17 participants 19 participants
0.986
(0.862 to 1.129)
1.044
(0.937 to 1.162)
TLC,Scan Trimmed,Distal,Day 28,n=17,19 Number Analyzed 17 participants 19 participants
1.712
(1.119 to 2.618)
1.079
(0.883 to 1.319)
TLC,Scan Trimmed,Total,Day 28,n=17,19 Number Analyzed 17 participants 19 participants
1.321
(0.998 to 1.749)
1.085
(0.933 to 1.263)
16.Secondary Outcome
Title Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes
Hide Description siRaw is a measure of the resistance in an individual's airway corrected for their lobar volume derived from the HRCT. It was measured at FRC and TLC. Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analysed (represented by n=X1, X2 in the category title). This table presents the SCRD12 scan trim pair data (in rows with categories containing Scan Trimmed and Day 12) and SCRD28 scan trim pair data (in rows with categories containing Scan Trimmed and Day 28) only.
Time Frame Baseline (Screening) and Days 12 and 28
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
Arm/Group Title All Placebo All NEMI
Hide Arm/Group Description:
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS or ELLIPTA dry powder inhaler (DPI).
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
Overall Number of Participants Analyzed 22 22
Geometric Mean (95% Confidence Interval)
Unit of Measure: kPa*s
FRC,Scan Trimmed,Right Upper,Day 12,n=17,16 Number Analyzed 17 participants 16 participants
1.117
(0.627 to 1.989)
0.961
(0.539 to 1.711)
FRC,Scan Trimmed,Right Upper,Day 28,n=16,18 Number Analyzed 16 participants 18 participants
1.200
(0.574 to 2.510)
0.923
(0.599 to 1.424)
FRC,Scan Trimmed,Left Upper,Day 12,n=18,17 Number Analyzed 18 participants 17 participants
1.053
(0.642 to 1.726)
0.945
(0.604 to 1.479)
FRC,Scan Trimmed,Left Upper,Day 28,n=16,19 Number Analyzed 16 participants 19 participants
1.139
(0.586 to 2.215)
0.687
(0.457 to 1.032)
FRC,Scan Trimmed,Right Middle,Day 12,n=17,16 Number Analyzed 17 participants 16 participants
0.496
(0.163 to 1.511)
1.022
(0.593 to 1.761)
FRC,Scan Trimmed,Right Middle,Day 28,n=16,18 Number Analyzed 16 participants 18 participants
1.259
(0.521 to 3.043)
1.424
(0.836 to 2.424)
FRC,Scan Trimmed,Right Lower,Day 12,n=17,17 Number Analyzed 17 participants 17 participants
0.921
(0.362 to 2.342)
1.121
(0.715 to 1.758)
FRC,Scan Trimmed,Right Lower,Day 28,n=16,19 Number Analyzed 16 participants 19 participants
0.688
(0.257 to 1.840)
0.920
(0.521 to 1.624)
FRC,Scan Trimmed,Left Lower,Day 12,n=17,17 Number Analyzed 17 participants 17 participants
1.075
(0.648 to 1.785)
0.884
(0.386 to 2.021)
FRC,Scan Trimmed,Left Lower,Day 28,n=16,19 Number Analyzed 16 participants 19 participants
1.573
(0.669 to 3.701)
0.876
(0.634 to 1.212)
TLC,Scan Trimmed,Right Upper,Day 12,n=19,17 Number Analyzed 19 participants 17 participants
1.037
(0.788 to 1.364)
1.035
(0.711 to 1.509)
TLC,Scan Trimmed,Right Upper,Day 28,n=18,19 Number Analyzed 18 participants 19 participants
1.292
(0.992 to 1.684)
1.262
(0.912 to 1.747)
TLC,Scan Trimmed,Left Upper,Day 12,n=20,18 Number Analyzed 20 participants 18 participants
1.133
(0.946 to 1.358)
1.064
(0.659 to 1.720)
TLC,Scan Trimmed,Left Upper,Day 28,n=18,20 Number Analyzed 18 participants 20 participants
1.203
(0.955 to 1.515)
1.145
(0.843 to 1.554)
TLC,Scan Trimmed,Right Middle,Day 12,n=18,17 Number Analyzed 18 participants 17 participants
1.094
(0.730 to 1.639)
1.101
(0.690 to 1.758)
TLC,Scan Trimmed,Right Middle,Day 28,n=18,19 Number Analyzed 18 participants 19 participants
1.575
(0.965 to 2.570)
1.557
(0.955 to 2.538)
TLC,Scan Trimmed,Right Lower,Day 12,n=20,18 Number Analyzed 20 participants 18 participants
0.747
(0.498 to 1.120)
1.290
(0.842 to 1.976)
TLC,Scan Trimmed,Right Lower,Day 28,n=18,20 Number Analyzed 18 participants 20 participants
1.161
(0.814 to 1.654)
1.427
(1.065 to 1.912)
TLC,Scan Trimmed,Left Lower,Day 12,n=20,18 Number Analyzed 20 participants 18 participants
1.018
(0.810 to 1.278)
1.118
(0.715 to 1.747)
TLC,Scan Trimmed,Left Lower,Day 28,n=18,20 Number Analyzed 18 participants 20 participants
1.240
(0.735 to 2.092)
1.178
(0.876 to 1.584)
17.Secondary Outcome
Title Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes at Day 28
Hide Description siRaw is a measure of the resistance in an individual's airway corrected for their lobar volume derived from the HRCT. It was measured at FRC and TLC. Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analysed (represented by n=X1, X2 in the category title). This table presents the D12D28 scan trim pair data only.
Time Frame Baseline (Day 12) and Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
Arm/Group Title All Placebo All NEMI
Hide Arm/Group Description:
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS or ELLIPTA dry powder inhaler (DPI).
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
Overall Number of Participants Analyzed 22 22
Geometric Mean (95% Confidence Interval)
Unit of Measure: kPa*s
FRC,Scan Trimmed,Right Upper,Day 28,n=16,17 Number Analyzed 16 participants 17 participants
1.079
(0.711 to 1.636)
1.073
(0.794 to 1.451)
FRC,Scan Trimmed,Left Upper,Day 28,n=16,18 Number Analyzed 16 participants 18 participants
1.249
(0.886 to 1.760)
1.011
(0.653 to 1.566)
FRC,Scan Trimmed,Right Middle,Day 28,n=16,17 Number Analyzed 16 participants 17 participants
1.097
(0.647 to 1.859)
1.354
(0.885 to 2.070)
FRC,Scan Trimmed,Right Lower,Day 28,n=16,18 Number Analyzed 16 participants 18 participants
1.241
(0.845 to 1.822)
1.261
(0.706 to 2.252)
FRC,Scan Trimmed,Left Lower,Day 28,n=16,18 Number Analyzed 16 participants 18 participants
1.760
(0.893 to 3.470)
1.165
(0.755 to 1.798)
TLC,Scan Trimmed,Right Upper,Day 28,n=17,18 Number Analyzed 17 participants 18 participants
1.132
(0.796 to 1.611)
1.142
(0.977 to 1.336)
TLC,Scan Trimmed,Left Upper,Day 28,n=17,19 Number Analyzed 17 participants 19 participants
0.992
(0.730 to 1.349)
1.089
(0.921 to 1.288)
TLC,Scan Trimmed,Right Middle,Day 28,n=17,18 Number Analyzed 17 participants 18 participants
1.915
(0.956 to 3.834)
1.564
(1.042 to 2.347)
TLC,Scan Trimmed,Right Lower,Day 28,n=17,19 Number Analyzed 17 participants 19 participants
1.380
(0.894 to 2.130)
1.064
(0.783 to 1.447)
TLC,Scan Trimmed,Left Lower,Day 28,n=17,19 Number Analyzed 17 participants 19 participants
1.453
(0.977 to 2.161)
1.042
(0.683 to 1.590)
18.Secondary Outcome
Title Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions
Hide Description siRaw is a measure of the resistance in an individual's airway corrected for their lobar volume derived from the HRCT. It was measured at FRC and TLC. Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analysed (represented by n=X1, X2 in the category title). This table presents the SCRD12 scan trim pair data (in rows with categories containing Scan Trimmed and Day 12) and SCRD28 scan trim pair data (in rows with categories containing Scan Trimmed and Day 28) only.
Time Frame Baseline (Screening) and Days 12 and 28
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
Arm/Group Title All Placebo All NEMI
Hide Arm/Group Description:
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS or ELLIPTA dry powder inhaler (DPI).
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
Overall Number of Participants Analyzed 22 22
Geometric Mean (95% Confidence Interval)
Unit of Measure: kPa*s
FRC,Scan Trimmed,Upper,Day 12,n=18,17 Number Analyzed 18 participants 17 participants
0.820
(0.443 to 1.517)
0.828
(0.531 to 1.292)
FRC,Scan Trimmed,Upper,Day 28,n=16,19 Number Analyzed 16 participants 19 participants
1.377
(0.679 to 2.793)
0.784
(0.546 to 1.124)
FRC,Scan Trimmed,Lower,Day 12,n=17,17 Number Analyzed 17 participants 17 participants
1.118
(0.559 to 2.239)
1.043
(0.516 to 2.109)
FRC,Scan Trimmed,Lower,Day 28,n=16,19 Number Analyzed 16 participants 19 participants
1.073
(0.529 to 2.177)
0.891
(0.601 to 1.321)
FRC,Scan Trimmed,Central,Day 12,n=18,17 Number Analyzed 18 participants 17 participants
0.931
(0.634 to 1.367)
0.878
(0.734 to 1.050)
FRC,Scan Trimmed,Central,Day 28,n=16,19 Number Analyzed 16 participants 19 participants
0.870
(0.598 to 1.265)
0.867
(0.709 to 1.060)
FRC,Scan Trimmed,Distal,Day 12,n=18,17 Number Analyzed 18 participants 17 participants
0.999
(0.617 to 1.617)
1.085
(0.567 to 2.077)
FRC,Scan Trimmed,Distal,Day 28,n=16,19 Number Analyzed 16 participants 19 participants
1.161
(0.566 to 2.380)
0.853
(0.604 to 1.204)
FRC,Scan Trimmed,Total,Day 12,n=18,17 Number Analyzed 18 participants 17 participants
0.983
(0.674 to 1.435)
0.961
(0.717 to 1.287)
FRC,Scan Trimmed,Total,Day 28,n=16,19 Number Analyzed 16 participants 19 participants
1.038
(0.656 to 1.641)
0.909
(0.719 to 1.150)
TLC,Scan Trimmed,Upper,Day 12,n=20,18 Number Analyzed 20 participants 18 participants
1.139
(0.886 to 1.464)
1.156
(0.723 to 1.849)
TLC,Scan Trimmed,Upper,Day 28,n=18,20 Number Analyzed 18 participants 20 participants
1.524
(1.101 to 2.111)
1.257
(0.950 to 1.664)
TLC,Scan Trimmed,Lower,Day 12,n=20,18 Number Analyzed 20 participants 18 participants
0.878
(0.665 to 1.161)
1.179
(0.822 to 1.690)
TLC,Scan Trimmed,Lower,Day 28,n=18,20 Number Analyzed 18 participants 20 participants
1.142
(0.740 to 1.760)
1.282
(0.982 to 1.673)
TLC,Scan Trimmed,Central,Day 12,n=20,18 Number Analyzed 20 participants 18 participants
0.994
(0.883 to 1.120)
0.990
(0.870 to 1.127)
TLC,Scan Trimmed,Central,Day 28,n=18,20 Number Analyzed 18 participants 20 participants
0.978
(0.904 to 1.059)
1.039
(0.931 to 1.160)
TLC,Scan Trimmed,Distal,Day 12,n=20,18 Number Analyzed 20 participants 18 participants
0.966
(0.735 to 1.271)
1.259
(0.815 to 1.946)
TLC,Scan Trimmed,Distal,Day 28,n=18,20 Number Analyzed 18 participants 20 participants
1.323
(0.869 to 2.014)
1.266
(0.981 to 1.633)
TLC,Scan Trimmed,Total,Day 12,n=20,18 Number Analyzed 20 participants 18 participants
1.000
(0.840 to 1.191)
1.093
(0.844 to 1.416)
TLC,Scan Trimmed,Total,Day 28,n=18,20 Number Analyzed 18 participants 20 participants
1.188
(0.958 to 1.473)
1.181
(0.978 to 1.427)
19.Secondary Outcome
Title Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions at Day 28
Hide Description siRaw is a measure of the resistance in an individual's airway corrected for their lobar volume derived from the HRCT. It was measured at FRC and TLC. Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analysed (represented by n=X1, X2 in the category title). This table presents the D12D28 scan trim pair data only.
Time Frame Baseline (Day 12) and Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
Arm/Group Title All Placebo All NEMI
Hide Arm/Group Description:
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS or ELLIPTA dry powder inhaler (DPI).
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
Overall Number of Participants Analyzed 22 22
Geometric Mean (95% Confidence Interval)
Unit of Measure: kPa*s
FRC,Scan Trimmed,Upper,Day 28,n=16,18 Number Analyzed 16 participants 18 participants
1.211
(0.852 to 1.722)
1.265
(0.872 to 1.836)
FRC,Scan Trimmed,Lower,Day 28,n=16,18 Number Analyzed 16 participants 18 participants
1.508
(0.929 to 2.448)
1.260
(0.778 to 2.041)
FRC,Scan Trimmed,Central,Day 28,n=16,18 Number Analyzed 16 participants 18 participants
0.977
(0.861 to 1.110)
0.921
(0.703 to 1.206)
FRC,Scan Trimmed,Distal,Day 28,n=16,18 Number Analyzed 16 participants 18 participants
1.356
(0.980 to 1.877)
1.227
(0.876 to 1.720)
FRC,Scan Trimmed,Total,Day 28,n=16,18 Number Analyzed 16 participants 18 participants
1.144
(0.922 to 1.418)
0.995
(0.723 to 1.368)
TLC,Scan Trimmed,Upper,Day 28,n=17,19 Number Analyzed 17 participants 19 participants
1.465
(0.934 to 2.300)
1.169
(1.050 to 1.302)
TLC,Scan Trimmed,Lower,Day 28,n=17,19 Number Analyzed 17 participants 19 participants
1.392
(0.936 to 2.072)
1.079
(0.813 to 1.430)
TLC,Scan Trimmed,Central,Day 28,n=17,19 Number Analyzed 17 participants 19 participants
0.973
(0.853 to 1.111)
1.038
(0.935 to 1.153)
TLC,Scan Trimmed,Distal,Day 28,n=17,19 Number Analyzed 17 participants 19 participants
1.689
(1.111 to 2.567)
1.073
(0.882 to 1.305)
TLC,Scan Trimmed,Total,Day 28,n=17,19 Number Analyzed 17 participants 19 participants
1.303
(0.990 to 1.717)
1.079
(0.932 to 1.250)
20.Secondary Outcome
Title Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes
Hide Description Change from Baseline in lung lobar volumes was measured at FRC and TLC scan conditions. Data was collected at longitudinal time points: Baseline (Screening), Day 12 and Day 28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe). The value at Screening was considered as Baseline. Change from baseline is the post-Baseline value minus the Baseline value. The study had a protocol amendment to reflect changes in manufacturing device from DISKUS to ELLIPTA after study had been initiated, but the 2 treatment arms remained the same i.e. Placebo and NEMI.There was no intent to compare two devices.
Time Frame Baseline (Screening) and Days 12 and 28
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
Arm/Group Title All Placebo All NEMI
Hide Arm/Group Description:
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS or ELLIPTA dry powder inhaler (DPI).
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
Overall Number of Participants Analyzed 22 22
Geometric Mean (95% Confidence Interval)
Unit of Measure: Liters
FRC,Right Upper,Day 12,n=17,16 Number Analyzed 17 participants 16 participants
0.989
(0.921 to 1.063)
0.971
(0.935 to 1.009)
FRC,Right Upper,Day 28,n=16,18 Number Analyzed 16 participants 18 participants
0.989
(0.929 to 1.053)
0.999
(0.952 to 1.048)
FRC,Left Upper,Day 12,n=18,17 Number Analyzed 18 participants 17 participants
0.995
(0.938 to 1.056)
0.993
(0.924 to 1.068)
FRC,Left Upper,Day 28,n=16,19 Number Analyzed 16 participants 19 participants
0.990
(0.935 to 1.048)
1.008
(0.955 to 1.064)
FRC,Right Middle,Day 12,n=17,16 Number Analyzed 17 participants 16 participants
0.931
(0.819 to 1.057)
0.979
(0.949 to 1.010)
FRC,Right Middle,Day 28,n=16,18 Number Analyzed 16 participants 18 participants
0.887
(0.708 to 1.111)
1.010
(0.964 to 1.060)
FRC,Right Lower,Day 12,n=18,17 Number Analyzed 18 participants 17 participants
1.021
(0.928 to 1.123)
0.976
(0.908 to 1.048)
FRC,Right Lower,Day 28,n=16,19 Number Analyzed 16 participants 19 participants
1.009
(0.907 to 1.124)
0.984
(0.927 to 1.044)
FRC,Left Lower,Day 12,n=18,17 Number Analyzed 18 participants 17 participants
0.996
(0.917 to 1.082)
0.979
(0.905 to 1.059)
FRC,Left Lower,Day 28,n=16,19 Number Analyzed 16 participants 19 participants
0.998
(0.915 to 1.089)
0.969
(0.898 to 1.045)
TLC,Right Upper,Day 12,n=19,17 Number Analyzed 19 participants 17 participants
0.991
(0.964 to 1.020)
0.992
(0.976 to 1.007)
TLC,Right Upper,Day 28,n=18,19 Number Analyzed 18 participants 19 participants
0.989
(0.967 to 1.012)
0.984
(0.965 to 1.004)
TLC,Left Upper,Day 12,n=20,18 Number Analyzed 20 participants 18 participants
1.003
(0.985 to 1.022)
0.990
(0.975 to 1.005)
TLC,Left Upper,Day 28,n=18,20 Number Analyzed 18 participants 20 participants
0.992
(0.978 to 1.008)
0.987
(0.968 to 1.006)
TLC,Right Middle,Day 12,n=19,17 Number Analyzed 19 participants 17 participants
0.935
(0.815 to 1.072)
0.990
(0.960 to 1.022)
TLC,Right Middle,Day 28,n=18,19 Number Analyzed 18 participants 19 participants
0.900
(0.741 to 1.094)
0.998
(0.969 to 1.028)
TLC,Right Lower,Day 12,n=20,18 Number Analyzed 20 participants 18 participants
1.027
(0.981 to 1.076)
0.973
(0.950 to 0.997)
TLC,Right Lower,Day 28,n=18,20 Number Analyzed 18 participants 20 participants
1.016
(0.963 to 1.072)
0.975
(0.946 to 1.005)
TLC,Left Lower,Day 12,n=20,18 Number Analyzed 20 participants 18 participants
1.015
(0.982 to 1.048)
0.977
(0.937 to 1.019)
TLC,Left Lower,Day 28,n=18,20 Number Analyzed 18 participants 20 participants
0.985
(0.953 to 1.018)
0.971
(0.929 to 1.015)
21.Secondary Outcome
Title Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Regions
Hide Description Change from Baseline in lung lobar volumes was measured at FRC and TLC scan conditions. Data was collected at longitudinal time points: Baseline (Screening), Day 12 and Day 28. At each time point it was measure at 5 Regions (Upper, Lower, Central, Distal & Total). The value at Screening was considered as Baseline. Change from Baseline is the post-Baseline value minus the Baseline value. The study had a protocol amendment to reflect changes in manufacturing device from DISKUS to ELLIPTA after study had been initiated, but the 2 treatment arms remained the same i.e. Placebo and NEMI.There was no intent to compare two devices.
Time Frame Baseline (Screening) and Days 12 and 28
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
Arm/Group Title All Placebo All NEMI
Hide Arm/Group Description:
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS or ELLIPTA dry powder inhaler (DPI).
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
Overall Number of Participants Analyzed 22 22
Geometric Mean (95% Confidence Interval)
Unit of Measure: Liters
FRC,Upper,Day 12,n=18,17 Number Analyzed 18 participants 17 participants
0.991
(0.935 to 1.051)
0.997
(0.932 to 1.068)
FRC,Upper,Day 28,n=16,19 Number Analyzed 16 participants 19 participants
0.987
(0.932 to 1.045)
1.010
(0.961 to 1.061)
FRC,Lower,Day 12,n=18,17 Number Analyzed 18 participants 17 participants
1.008
(0.923 to 1.100)
0.979
(0.911 to 1.051)
FRC,Lower,Day 28,n=16,19 Number Analyzed 16 participants 19 participants
1.002
(0.912 to 1.101)
0.978
(0.918 to 1.041)
FRC,Total,Day 12,n=18,17 Number Analyzed 18 participants 17 participants
0.998
(0.931 to 1.070)
0.988
(0.925 to 1.056)
FRC,Total,Day 28,n=16,19 Number Analyzed 16 participants 19 participants
0.993
(0.925 to 1.065)
0.995
(0.944 to 1.049)
TLC,Upper,Day 12,n=20,18 Number Analyzed 20 participants 18 participants
0.997
(0.980 to 1.013)
0.991
(0.978 to 1.004)
TLC,Upper,Day 28,n=18,20 Number Analyzed 18 participants 20 participants
0.990
(0.978 to 1.002)
0.989
(0.972 to 1.006)
TLC,Lower,Day 12,n=20,18 Number Analyzed 20 participants 18 participants
1.021
(0.985 to 1.057)
0.977
(0.954 to 1.001)
TLC,Lower,Day 28,n=18,20 Number Analyzed 18 participants 20 participants
1.000
(0.961 to 1.040)
0.975
(0.947 to 1.004)
TLC,Total,Day 12,n=20,18 Number Analyzed 20 participants 18 participants
1.008
(0.985 to 1.030)
0.985
(0.970 to 1.000)
TLC,Total,Day 28,n=18,20 Number Analyzed 18 participants 20 participants
0.993
(0.972 to 1.015)
0.983
(0.962 to 1.004)
22.Secondary Outcome
Title Change From Baseline in Trachea Length and Diameter at FRC and TLC
Hide Description Trachea length and diameter was derived from HRCT. It was measured at both FRC and TLC scan conditions. The value at Screening was considered as Baseline. Change from Baseline is the post-Baseline value minus the Baseline value. The change from Baseline data is presented for Day 12 and Day 28 for trachea length and diameter. The study had a protocol amendment to reflect changes in manufacturing device from DISKUS to ELLIPTA after study had been initiated, but the 2 treatment arms remained the same i.e. Placebo and NEMI.There was no intent to compare two devices.
Time Frame Baseline (Screening) and Days 12 and 28
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
Arm/Group Title All Placebo All NEMI
Hide Arm/Group Description:
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS or ELLIPTA dry powder inhaler (DPI).
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS or ELLIPTA dry powder inhaler (DPI).
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: Millimeters
FRC,Length,Day 12,n=18,17 Number Analyzed 18 participants 17 participants
0.094  (7.2507) 0.972  (6.5552)
FRC,Length,Day 28,n=16,19 Number Analyzed 16 participants 19 participants
0.796  (7.7795) 0.281  (5.1808)
FRC,Diameter,Day 12,n=18,17 Number Analyzed 18 participants 17 participants
0.225  (1.3641) 0.252  (1.0023)
FRC,Diameter,Day 28,n=16,19 Number Analyzed 16 participants 19 participants
0.225  (1.3812) 0.116  (1.1600)
TLC,Length,Day 12,n=20,18 Number Analyzed 20 participants 18 participants
-0.164  (2.8331) 0.827  (3.1842)
TLC,Length,Day 28,n=18,20 Number Analyzed 18 participants 20 participants
-0.094  (2.8480) 0.069  (3.4882)
TLC,Diameter,Day 12,n=20,18 Number Analyzed 20 participants 18 participants
0.134  (0.4670) 0.070  (0.4222)
TLC,Diameter,Day 28,n=18,20 Number Analyzed 18 participants 20 participants
0.076  (0.4751) -0.188  (0.4983)
23.Secondary Outcome
Title Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)
Hide Description PEF measurements were taken (in triplicate) daily in the morning before dose administration, as soon as it is safe for the participant to do so. The best/highest result was recorded. Participants were provided with a handheld device. Baseline here is defined as average of Day 1 to Day 3. Change from Baseline is the post-Baseline value minus the Baseline value. The study had a protocol amendment to reflect changes in manufacturing device from DISKUS to ELLIPTA after study had been initiated, but the 2 treatment arms remained the same i.e. Placebo and NEMI. There was no intent to compare two devices.
Time Frame Baseline and up to Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population.
Arm/Group Title All Placebo All NEMI
Hide Arm/Group Description:
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS or ELLIPTA dry powder inhaler (DPI).
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
Overall Number of Participants Analyzed 22 22
Mean (95% Confidence Interval)
Unit of Measure: Liters per minute
Day 4
2.5
(-3.0 to 11.4)
4.1
(-5.4 to 13.7)
Day 5
-3.0
(-12.8 to 6.8)
6.3
(-4.1 to 16.8)
Day 6
7.3
(-3.7 to 18.4)
7.5
(-6.2 to 21.3)
Day 7
8.1
(-3.0 to 19.3)
11.3
(-1.3 to 24.0)
Day 8
0.8
(-12.7 to 14.4)
8.2
(-5.3 to 21.8)
Day 9
10.0
(-5.5 to 25.7)
17.7
(-1.4 to 37.0)
Day 10
12.9
(-2.2 to 28.2)
15.2
(2.8 to 27.6)
Day 11
14.1
(-3.3 to 31.5)
21.1
(1.2 to 41.0)
Day 12
6.2
(-11.2 to 23.8)
20.4
(2.2 to 38.7)
Day 13
21.0
(-4.5 to 46.6)
18.8
(-3.1 to 40.8)
Day 14
9.4
(-11.7 to 30.7)
15.3
(-0.2 to 30.8)
Day 15
17.7
(-2.3 to 37.7)
10.8
(-6.2 to 28.0)
Day 16
14.1
(-10.7 to 39.0)
12.5
(-1.8 to 26.8)
Day 17
17.6
(-3.9 to 39.3)
11.5
(-1.7 to 24.7)
Day 18
11.8
(-10.6 to 34.3)
11.9
(-3.7 to 27.5)
Day 19
12.9
(-4.1 to 30.1)
7.1
(-7.2 to 21.5)
Day 20
6.4
(-16.5 to 29.4)
3.3
(-9.3 to 16.0)
Day 21
20.1
(4.5 to 35.6)
4.1
(-7.8 to 16.1)
Day 22
10.7
(-11.0 to 32.5)
6.2
(-5.0 to 17.6)
Day 23
16.0
(-5.2 to 37.3)
2.8
(-7.3 to 13.1)
Day 24
19.0
(-5.3 to 43.5)
6.9
(-7.6 to 21.4)
Day 25
23.8
(2.9 to 44.7)
11.6
(-2.8 to 26.1)
Day 26
20.8
(0.8 to 40.7)
14.4
(-0.9 to 29.7)
Day 27
29.1
(3.8 to 54.5)
17.6
(-5.4 to 40.7)
Day 28
19.3
(-2.7 to 41.4)
11.2
(-7.9 to 30.4)
Day 29
20.8
(-3.5 to 45.2)
13.8
(-6.4 to 34.2)
Day 30
9.5
(-16.2 to 35.3)
17.2
(-7.2 to 41.7)
Day 31
9.5
(-11.9 to 31.0)
11.5
(-8.1 to 31.1)
Day 32
5.9
(-18.7 to 30.5)
17.2
(-1.9 to 36.4)
Day 33
9.5
(-15.2 to 34.3)
7.3
(-15.7 to 30.3)
Day 34
6.4
(-22.3 to 35.3)
6
(-5.0 to 17.0)
Day 35
17.0
(-6.0 to 40.1)
7
(-3.5 to 17.5)
Day 36
16.7
(-4.2 to 37.7)
3
(-9.0 to 15.0)
Day 37
13.4
(-8.4 to 35.2)
9.2
(-1.9 to 20.4)
Day 38
12.6
(-7.4 to 32.6)
5.5
(-5.9 to 16.9)
Day 39
13.4
(-8.1 to 35.0)
9.5
(-6.4 to 25.4)
Day 40
13.7
(-8.6 to 36.0)
10
(-5.1 to 25.1)
Day 41
16.7
(-10.1 to 43.6)
8
(-7.6 to 23.6)
Day 42
16.7
(-8.2 to 41.7)
10.2
(-6.3 to 26.8)
Day 43
16.4
(-5.8 to 38.8)
15
(-1.0 to 31.0)
Day 44
12.6
(-14.2 to 39.4)
9.5
(-5.33 to 24.3)
Day 45
14.5
(-7.0 to 36.1)
7.5
(-5.8 to 20.8)
Day 46
9.7
(-8.8 to 28.2)
5
(-9.2 to 19.2)
Day 47
12.3
(-6.4 to 31.1)
7.2
(-6.9 to 21.4)
Day 48
13.4
(-13.1 to 40.0)
6.2
(-9.7 to 22.2)
Day 49
14.5
(-11.1 to 40.2)
12.8
(-3.3 to 28.9)
Day 50
20.1
(-0.5 to 40.7)
9.7
(-7.5 to 27.0)
Day 51
18.9
(-4.8 to 42.7)
13.2
(-6.9 to 33.4)
Day 52
14.5
(-7.3 to 36.4)
21.5
(0.1 to 43.0)
Day 53
8.9
(-11.9 to 29.9)
17.3
(-4.6 to 39.3)
Day 54
10.6
(-10.8 to 32.1)
14.4
(-4.3 to 33.2)
Day 55
21.0
(-14.4 to 56.6)
18.7
(-5.4 to 43.0)
Day 56
12.5
(-11.1 to 36.2)
26.5
(-0.3 to 53.4)
Day 57
16.2
(-6.8 to 39.3)
32.3
(5.9 to 58.7)
Day 58
14.2
(-9.3 to 37.8)
10.4
(-7.2 to 28.1)
Day 59
15.1
(-7.9 to 38.1)
11.2
(-2.84 to 25.3)
Day 60
16.4
(-12.5 to 45.5)
1.2
(-11.1 to 13.6)
Day 61
18.9
(-1.9 to 39.9)
5.7
(-9.0 to 20.5)
Day 62
16.9
(-6.5 to 40.4)
10.2
(-6.6 to 27.1)
Day 63
22.4
(-2.7 to 47.6)
7.2
(-8.6 to 23.1)
Day 64
7.9
(-16.0 to 31.9)
9.5
(-5.9 to 24.9)
Day 65
12.9
(-4.9 to 30.9)
15
(-3.7 to 33.7)
Day 66
10.0
(-9.2 to 29.4)
10
(-5.3 to 25.3)
Day 67
12.7
(-7.2 to 32.7)
15.2
(-4.4 to 34.9)
Day 68
14.3
(-5.0 to 33.6)
11
(-4.02 to 26.0)
Day 69
11.9
(-5.6 to 29.5)
11.5
(-6.0 to 29.0)
Day 70
10.8
(-6.4 to 28.2)
11.2
(-4.0 to 26.5)
Day 71
7.9
(-11.0 to 26.9)
11
(-5.31 to 27.3)
Day 72
7.9
(-11.3 to 27.2)
14.9
(-0.3 to 30.1)
Day 73
3.2
(-8.2 to 14.7)
14.3
(-5.3 to 34.0)
Day 74
6.2
(-10.0 to 22.6)
10.7
(-6.7 to 28.2)
Day 75
7.13
(-10.3 to 24.6)
13
(-7.4 to 33.4)
Day 76
12.1
(-6.4 to 30.7)
11.2
(-8.2 to 30.7)
Day 77
12.3
(-15.6 to 40.2)
16.5
(-5.1 to 38.1)
Day 78
10.4
(-9.9 to 30.8)
12
(-4.2 to 28.2)
Day 79
21.2
(-5.9 to 48.4)
9.7
(-10.3 to 29.8)
Day 80
18.1
(-7.1 to 43.3)
10
(-8.0 to 28.0)
Day 81
7.3
(-8.6 to 23.2)
7
(-11.0 to 25.0)
Day 82
5.6
(-11.5 to 22.8)
10
(-7.2 to 27.2)
Day 83
21.1
(-7.7 to 49.9)
13.0
(-5.7 to 31.8)
Day 84
12.9
(-14.9 to 40.9)
11.6
(-19.7 to 43.0)
24.Secondary Outcome
Title Mean Number of Occasions of Rescue Usage Per Day
Hide Description For reliever/rescue use, bronchodilator use recorded in the diary was summarized as the mean number of occasions of rescue use per day.where a rescue-free day was defined as a 24-hour period in which the number of occasions of bronchodilator use was zero. Number of occasions bronchodilator taken in the last 24 hours were collected in the daily diary. The mean number of occasions of rescue use per day, were calculated for each participant during the four weekly periods (Weeks 1 to 4; Weeks 5-8 and Weeks 9-12). The study had a protocol amendment to reflect changes in manufacturing device from DISKUS to ELLIPTA after study had been initiated, but the 2 treatment arms remained the same i.e. Placebo and NEMI.There was no intent to compare two devices.
Time Frame Weeks 1 to 4; Weeks 5 to 8 and Weeks 9 to 12
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
Arm/Group Title All Placebo All NEMI
Hide Arm/Group Description:
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS or ELLIPTA dry powder inhaler (DPI).
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: Rescue use per day
Weeks 1-4,n=22,21 Number Analyzed 22 participants 21 participants
3.05  (2.520) 2.77  (2.432)
Weeks 5-8,n=19,20 Number Analyzed 19 participants 20 participants
2.93  (2.342) 2.81  (2.827)
Weeks 9-12,n=19,20 Number Analyzed 19 participants 20 participants
3.19  (2.065) 2.84  (2.569)
25.Secondary Outcome
Title Mean Rescue Medication Free Days
Hide Description For reliever/rescue use, bronchodilator use recorded in the diary was summarized as the mean number of occasions of rescue use per day, where a rescue-free day was defined as a 24-hour period in which the number of occasions of bronchodilator use was zero. Number of occasions bronchodilator taken in the last 24 hours were collected in the daily diary. The mean number of rescue free days were calculated for each participant during the four weekly periods (Weeks 1 to 4; Weeks 5-8 and Weeks 9-12). The study had a protocol amendment to reflect changes in manufacturing device from DISKUS to ELLIPTA after study had been initiated, but the 2 treatment arms remained the same i.e. Placebo and NEMI. There was no intent to compare two devices.
Time Frame Weeks 1 to 4; Weeks 5 to 8 and Weeks 9 to 12
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
Arm/Group Title All Placebo All NEMI
Hide Arm/Group Description:
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS or ELLIPTA dry powder inhaler (DPI).
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: Days
Weeks 1-4,n=22,21 Number Analyzed 22 participants 21 participants
7.5  (9.21) 7.7  (10.06)
Weeks 5-8,n=19,20 Number Analyzed 19 participants 20 participants
5.8  (8.58) 9.0  (12.14)
Weeks 9-12,n=19,20 Number Analyzed 19 participants 20 participants
3.7  (6.68) 7.9  (11.14)
26.Secondary Outcome
Title Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC)
Hide Description FEV1 is the volume of air that can forcibly be blown out in one second. A triplicate FEV1 measurement were taken daily in the morning before dose administration using the site's spirometer as soon as it was safe to do so. FVC is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. Baseline is the latest available measurement from Day 2 Within 48 hours /discharge (On Treatment) and Day 1 (Pre-Treatment). Change from Baseline is the post-Baseline value minus Baseline value. The study had a protocol amendment to reflect changes in manufacturing device from DISKUS to ELLIPTA after study had been initiated, but the 2 treatment arms remained the same i.e. Placebo and NEMI.There was no intent to compare two devices.
Time Frame Baseline and Days 12, 28, 56, 84
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
Arm/Group Title All Placebo All NEMI
Hide Arm/Group Description:
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS or ELLIPTA dry powder inhaler (DPI).
Participants were administered with either NEMI 1000 micrograms (mcg) once daily in the morning using DISKUS DPI or 700 mcg once daily in the morning using ELLIPTA DPI before breakfast for 84 consecutive days
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: Liters
FEV1,Day 12,n=20,18 Number Analyzed 20 participants 18 participants
-0.001  (0.1681) 0.084  (0.1879)
FEV1,Day 28,n=19,20 Number Analyzed 19 participants 20 participants
0.005  (0.2227) 0.094  (0.2035)
FEV1,Day 56,n=19,20 Number Analyzed 19 participants 20 participants
-0.014  (0.1783) 0.112  (0.2613)
FEV1,Day 84,n=17,20 Number Analyzed 17 participants 20 participants
-0.029  (0.1281) 0.077  (0.2747)
FVC,Day 12,n=20,18 Number Analyzed 20 participants 18 participants
-0.024  (0.4723) 0.062  (0.3770)
FVC,Day 28,n=19,20 Number Analyzed 19 participants 20 participants
0.024  (0.4159) 0.231  (0.4270)
FVC,Day 56,n=19,20 Number Analyzed 19 participants 20 participants
-0.078  (0.4106) 0.212  (0.4827)
FVC,Day 84,n=17,20 Number Analyzed 17 participants 20 participants
-0.104  (0.3786) 0.123  (0.4579)
27.Secondary Outcome
Title Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline
Hide Description Blood samples were collected to analyze the following s hematology parameters: Hemoglobin, Hematocrit, Mean Corpuscle Hemoglobin (MCH), Mean Corpuscle Volume (MCV), Platelet count, Red Blood Cell (RBC) count, White Blood Cell (WBC) count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils. Participants were counted in the worst case category that their value changes to (low or high), unless there is no change in their category. Participants whose lab value category was unchanged (example given [e.g.],High to High), or whose value became normal, were not recorded. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. The value at Screening was considered as Baseline. Data for Worst Case Laboratory Hematology values Post-Baseline Relative to Baseline has been presented.
Time Frame Baseline (Screening) and up to 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population.
Arm/Group Title Placebo Via DISKUS NEMI 1000 mcg Via DISKUS Placebo Via ELLIPTA NEMI 700 mcg Via ELLIPTA
Hide Arm/Group Description:
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS DPI.
Participants were administered with NEMI 1000 mcg once daily in the morning before breakfast for 84 consecutive days using DISKUS DPI.
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
Overall Number of Participants Analyzed 14 14 8 8
Measure Type: Count of Participants
Unit of Measure: Participants
Basophils,To Low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Basophils,To High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Eosinophils,To Low
2
  14.3%
4
  28.6%
1
  12.5%
0
   0.0%
Eosinophils,To High
1
   7.1%
1
   7.1%
0
   0.0%
1
  12.5%
Hemoglobin,To Low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hemoglobin,To High
1
   7.1%
0
   0.0%
0
   0.0%
2
  25.0%
Hematocrit,To Low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hematocrit,To High
3
  21.4%
3
  21.4%
0
   0.0%
0
   0.0%
Lymphocytes,To Low
0
   0.0%
1
   7.1%
0
   0.0%
1
  12.5%
Lymphocytes,To High
1
   7.1%
0
   0.0%
0
   0.0%
0
   0.0%
MCH,To Low
0
   0.0%
1
   7.1%
0
   0.0%
0
   0.0%
MCH,To High
1
   7.1%
0
   0.0%
0
   0.0%
1
  12.5%
MCV,To Low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
MCV,To High
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
Monocytes,To Low
2
  14.3%
3
  21.4%
1
  12.5%
0
   0.0%
Monocytes,To High
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
Total Neutrophils,To Low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Total Neutrophils,To High
4
  28.6%
1
   7.1%
2
  25.0%
1
  12.5%
Platelet count,To Low
1
   7.1%
0
   0.0%
1
  12.5%
0
   0.0%
Platelet count,To High
0
   0.0%
1
   7.1%
1
  12.5%
0
   0.0%
RBC,To Low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
RBC,To High
0
   0.0%
1
   7.1%
0
   0.0%
1
  12.5%
WBC,To Low
1
   7.1%
0
   0.0%
0
   0.0%
0
   0.0%
WBC,To High
4
  28.6%
2
  14.3%
2
  25.0%
1
  12.5%
28.Secondary Outcome
Title Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline
Hide Description Blood samples were collected to analyze the following Chemistry parameters: Albumin, Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Direct Bilirubin, Total Bilirubin, Calcium, C-Reactive protein, Creatinine, Glucose, Potassium, Sodium, Total Protein and Urea/Blood urea nitrogen. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there is no change in their category. Participants whose lab value category was unchanged e.g. High to High), or whose value became normal, were not recorded. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. The value at Screening was considered as Baseline. Data for Worst Case Laboratory chemistry values Post-Baseline Relative to Baseline has been presented.
Time Frame Baseline (Screening) and up to 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population.
Arm/Group Title Placebo Via DISKUS NEMI 1000 mcg Via DISKUS Placebo Via ELLIPTA NEMI 700 mcg Via ELLIPTA
Hide Arm/Group Description:
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS DPI
Participants were administered with NEMI 1000 mcg once daily in the morning before breakfast for 84 consecutive days using DISKUS DPI.
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI
Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI
Overall Number of Participants Analyzed 14 14 8 8
Measure Type: Count of Participants
Unit of Measure: Participants
Albumin,To Low
0
   0.0%
0
   0.0%
1
  12.5%
0
   0.0%
Albumin,To High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALP,To Low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALP,To High
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
ALT,To Low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALT,To High
1
   7.1%
0
   0.0%
1
  12.5%
1
  12.5%
AST,To Low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
AST,To High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Direct Bilirubin,To Low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Direct Bilirubin,To High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Total Bilirubin,To Low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Total Bilirubin,To High
1
   7.1%
0
   0.0%
0
   0.0%
0
   0.0%
Calcium,To Low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Calcium,To High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
C-Reactive protein,To Low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
C-Reactive protein,To High
4
  28.6%
5
  35.7%
3
  37.5%
0
   0.0%
Creatinine,To Low
1
   7.1%
0
   0.0%
1
  12.5%
0
   0.0%
Creatinine,To High
0
   0.0%
1
   7.1%
1
  12.5%
1
  12.5%
Glucose,To Low
1
   7.1%
1
   7.1%
1
  12.5%
0
   0.0%
Glucose,To High
3
  21.4%
2
  14.3%
2
  25.0%
0
   0.0%
Potassium,To Low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Potassium,To High
0
   0.0%
0
   0.0%
1
  12.5%
0
   0.0%
Sodium,To Low
0
   0.0%
2
  14.3%
2
  25.0%
0
   0.0%
Sodium,To High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Total Protein,To Low
1
   7.1%
1
   7.1%
0
   0.0%
0
   0.0%
Total Protein,To High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Urea/BUN,To Low
1
   7.1%
0
   0.0%
0
   0.0%
0
   0.0%
Urea/BUN,To High
0
   0.0%
0
   0.0%
1
  12.5%
1
  12.5%
29.Secondary Outcome
Title Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Hide Description Vital signs were measured in semi-supine position after 5 minutes rest and included Systolic blood pressure (SBP), Diastolic blood pressure (DBP), Heart rate (HR). Data for number of participants with Post-Baseline worst case Vital Sign results relative to PCI Criteria relative to Baseline was presented. PCI ranges were: SBP (lower: <85 and upper: >160 mmHg), DBP (lower: <45 and upper: >100 mmHg), and HR (lower: <40 and upper: >110 bpm). The value at Screening was considered as Baseline.
Time Frame Baseline (Screening) and up to 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population.
Arm/Group Title Placebo Via DISKUS NEMI 1000 mcg Via DISKUS Placebo Via ELLIPTA NEMI 700 mcg Via ELLIPTA
Hide Arm/Group Description:
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS DPI
Participants were administered with NEMI 1000 mcg once daily in the morning before breakfast for 84 consecutive days using DISKUS DPI.
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI
Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
Overall Number of Participants Analyzed 14 14 8 8
Measure Type: Count of Participants
Unit of Measure: Participants
SBP, To Low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
SBP, To High
0
   0.0%
0
   0.0%
0
   0.0%
2
  25.0%
DBP, To Low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
DBP, To High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
HR, To Low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
HR, To High
2
  14.3%
1
   7.1%
0
   0.0%
1
  12.5%
30.Secondary Outcome
Title Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings
Hide Description A Single 12-lead ECGs was obtained at screening and at each other timepoint during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT interval corrected using the Fridericia's formula (QTcF) intervals. Data for number of participants with worst case post-Baseline abnormal ECG findings was reported. The value at Screening was considered as Baseline.
Time Frame Up to 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population.
Arm/Group Title Placebo Via DISKUS NEMI 1000 mcg Via DISKUS Placebo Via ELLIPTA NEMI 700 mcg Via ELLIPTA
Hide Arm/Group Description:
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS DPI
Participants were administered with NEMI 1000 mcg once daily in the morning before breakfast for 84 consecutive days using DISKUS DPI.
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI
Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
Overall Number of Participants Analyzed 14 14 8 8
Measure Type: Count of Participants
Unit of Measure: Participants
Abnormal - not clinically significant
10
  71.4%
7
  50.0%
6
  75.0%
7
  87.5%
Abnormal - clinically significant
0
   0.0%
0
   0.0%
1
  12.5%
0
   0.0%
31.Secondary Outcome
Title Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Hide Description An AE is any untoward medical occurrence in a clinical investigation participant, or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward medical occurrence that at any dose, resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, is associated with liver injury and impaired liver function or any other situation according to medical or scientific judgment was categorized as SAE. Number of participants with AEs and SAEs have been reported.
Time Frame Up to 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population.
Arm/Group Title Placebo Via DISKUS NEMI 1000 mcg Via DISKUS Placebo Via ELLIPTA NEMI 700 mcg Via ELLIPTA
Hide Arm/Group Description:
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS DPI
Participants were administered with NEMI 1000 mcg once daily in the morning before breakfast for 84 consecutive days using DISKUS DPI.
Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI
Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
Overall Number of Participants Analyzed 14 14 8 8
Measure Type: Count of Participants
Unit of Measure: Participants
Any AE
11
  78.6%
11
  78.6%
5
  62.5%
5
  62.5%
Any SAE
2
  14.3%
3
  21.4%
4
  50.0%
0
   0.0%
32.Secondary Outcome
Title Maximum Plasma Concentration (Cmax) Following Administration of NEMI
Hide Description Blood samples for pharmacokinetic (PK) analysis was collected at the indicated time points following administration of NEMI via DISKUS and ELLIPTA.
Time Frame Day 1: 5 minutes Post-dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population comprised of participants in all subject population for whom a pharmacokinetic sample was obtained and analyzed.
Arm/Group Title NEMI 1000 mcg Via DISKUS NEMI 700 mcg Via ELLIPTA
Hide Arm/Group Description:
Participants were administered with NEMI 1000 mcg once daily in the morning before breakfast for 84 consecutive days using DISKUS DPI
Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI
Overall Number of Participants Analyzed 14 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Picograms per milliliter
508.4
(69%)
1103.4
(34%)
33.Secondary Outcome
Title Trough Concentration Following Administration of NEMI
Hide Description Blood samples for pharmacokinetic (PK) analysis was collected at the indicated time points following administration of NEMI via DISKUS and ELLIPTA.
Time Frame Day 1: 24 Hours post-dose; Days 12, 28, 56, 84: Pre-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
Arm/Group Title NEMI 1000 mcg Via DISKUS NEMI 700 mcg Via ELLIPTA
Hide Arm/Group Description:
Participants were administered with NEMI 1000 mcg once daily in the morning before breakfast for 84 consecutive days using DISKUS DPI
Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI
Overall Number of Participants Analyzed 14 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Picograms per milliliter
Day 1,24 hour, n=8,2 Number Analyzed 8 participants 2 participants
313.9
(61%)
NA [1] 
(NA%)
Day 12,pre-dose,n=9,5 Number Analyzed 9 participants 5 participants
1097.1
(38%)
1077.2
(23%)
Day 28,pre-dose, n=9,7 Number Analyzed 9 participants 7 participants
1194.3
(76%)
1225.8
(50%)
Day 56,pre-dose,n=11,7 Number Analyzed 11 participants 7 participants
1155.1
(60%)
1171.6
(49%)
Day 84,pre-dose,n=11,7 Number Analyzed 11 participants 7 participants
1339.6
(53%)
1058.2
(33%)
[1]
Full summary statistics are only calculated if there are 3 or more quantifiable values. There were only 2 evaluable participants in this arm for this time point and therefore data was not available.
Time Frame Adverse events (AEs) were collected from the start of study treatment until the follow up (Up to 14 weeks)
Adverse Event Reporting Description All Subjects Population was used to collect Adverse events.
 
Arm/Group Title Placebo Via DISKUS NEMI 1000 mcg Via DISKUS Placebo Via ELLIPTA NEMI 700 mcg Via ELLIPTA
Hide Arm/Group Description Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using DISKUS DPI Participants were administered with NEMI 1000 mcg once daily in the morning before breakfast for 84 consecutive days using DISKUS DPI. Participants were administered with placebo matching NEMI once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI Participants were administered with NEMI 700 mcg once daily in the morning before breakfast for 84 consecutive days using ELLIPTA DPI.
All-Cause Mortality
Placebo Via DISKUS NEMI 1000 mcg Via DISKUS Placebo Via ELLIPTA NEMI 700 mcg Via ELLIPTA
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)      0/14 (0.00%)      0/8 (0.00%)      0/8 (0.00%)    
Hide Serious Adverse Events
Placebo Via DISKUS NEMI 1000 mcg Via DISKUS Placebo Via ELLIPTA NEMI 700 mcg Via ELLIPTA
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/14 (14.29%)      3/14 (21.43%)      4/8 (50.00%)      0/8 (0.00%)    
Cardiac disorders         
Coronary artery disease  1  0/14 (0.00%)  0 0/14 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
Infections and infestations         
Pneumonia  1  0/14 (0.00%)  0 1/14 (7.14%)  1 2/8 (25.00%)  2 0/8 (0.00%)  0
Investigations         
Oxygen saturation decreased  1  0/14 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Back pain  1  1/14 (7.14%)  1 0/14 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0
Nervous system disorders         
Cerebrovascular accident  1  0/14 (0.00%)  0 0/14 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
Renal and urinary disorders         
Renal failure  1  0/14 (0.00%)  0 0/14 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Chronic obstructive pulmonary disease  1  0/14 (0.00%)  0 2/14 (14.29%)  2 1/8 (12.50%)  2 0/8 (0.00%)  0
Bronchospasm  1  1/14 (7.14%)  1 0/14 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0
Laryngospasm  1  1/14 (7.14%)  1 0/14 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0
Pulmonary oedema  1  0/14 (0.00%)  0 0/14 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Via DISKUS NEMI 1000 mcg Via DISKUS Placebo Via ELLIPTA NEMI 700 mcg Via ELLIPTA
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/14 (71.43%)      10/14 (71.43%)      5/8 (62.50%)      5/8 (62.50%)    
Cardiac disorders         
Arrhythmia  1  0/14 (0.00%)  0 0/14 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
Eye disorders         
Conjunctival haemorrhage  1  0/14 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0
Gastrointestinal disorders         
Nausea  1  0/14 (0.00%)  0 1/14 (7.14%)  1 2/8 (25.00%)  2 0/8 (0.00%)  0
Toothache  1  0/14 (0.00%)  0 2/14 (14.29%)  2 0/8 (0.00%)  0 0/8 (0.00%)  0
Abdominal pain  1  1/14 (7.14%)  1 0/14 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0
Abdominal pain upper  1  1/14 (7.14%)  1 0/14 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0
Dyspepsia  1  0/14 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0
Vomiting  1  0/14 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0
Diarrhoea  1  3/14 (21.43%)  3 2/14 (14.29%)  2 0/8 (0.00%)  0 1/8 (12.50%)  1
General disorders         
Chest pain  1  2/14 (14.29%)  4 0/14 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0
Chills  1  0/14 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0
Drug intolerance  1  0/14 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0
Pyrexia  1  0/14 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0
Immune system disorders         
Seasonal allergy  1  1/14 (7.14%)  1 0/14 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0
Infections and infestations         
Nasopharyngitis  1  1/14 (7.14%)  1 1/14 (7.14%)  1 1/8 (12.50%)  1 2/8 (25.00%)  2
Oral herpes  1  1/14 (7.14%)  1 0/14 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1
Oral candidiasis  1  0/14 (0.00%)  0 0/14 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
Periorbital cellulitis  1  1/14 (7.14%)  1 0/14 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0
Pneumonia  1  0/14 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0
Tooth infection  1  0/14 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0
Investigations         
Blood magnesium decreased  1  0/14 (0.00%)  0 0/14 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
Metabolism and nutrition disorders         
Hyperglycaemia  1  0/14 (0.00%)  0 1/14 (7.14%)  1 1/8 (12.50%)  1 0/8 (0.00%)  0
Hypokalaemia  1  0/14 (0.00%)  0 0/14 (0.00%)  0 2/8 (25.00%)  2 0/8 (0.00%)  0
Hypoglycaemia  1  0/14 (0.00%)  0 0/14 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
Hypomagnesaemia  1  0/14 (0.00%)  0 0/14 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
Hyponatraemia  1  0/14 (0.00%)  0 0/14 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
Hypophosphataemia  1  0/14 (0.00%)  0 0/14 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Back pain  1  1/14 (7.14%)  1 1/14 (7.14%)  1 0/8 (0.00%)  0 1/8 (12.50%)  1
Musculoskeletal pain  1  2/14 (14.29%)  2 1/14 (7.14%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0
Pain in extremity  1  2/14 (14.29%)  4 0/14 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0
Joint swelling  1  1/14 (7.14%)  1 0/14 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0
Neck pain  1  0/14 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0
Arthralgia  1  1/14 (7.14%)  1 0/14 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0
Nervous system disorders         
Headache  1  1/14 (7.14%)  1 4/14 (28.57%)  10 1/8 (12.50%)  1 0/8 (0.00%)  0
Aphonia  1  1/14 (7.14%)  1 0/14 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0
Sciatica  1  0/14 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0
Psychiatric disorders         
Anxiety disorder  1  0/14 (0.00%)  0 0/14 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
Depressive symptom  1  1/14 (7.14%)  1 0/14 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0
Insomnia  1  0/14 (0.00%)  0 0/14 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
Panic attack  1  1/14 (7.14%)  1 0/14 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0
Renal and urinary disorders         
Proteinuria  1  0/14 (0.00%)  0 0/14 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Dyspnoea  1  3/14 (21.43%)  3 1/14 (7.14%)  2 1/8 (12.50%)  1 0/8 (0.00%)  0
Cough  1  0/14 (0.00%)  0 2/14 (14.29%)  2 0/8 (0.00%)  0 1/8 (12.50%)  2
Oropharyngeal pain  1  1/14 (7.14%)  1 1/14 (7.14%)  1 0/8 (0.00%)  0 1/8 (12.50%)  1
Bronchospasm  1  0/14 (0.00%)  0 1/14 (7.14%)  1 1/8 (12.50%)  1 0/8 (0.00%)  0
Nasal congestion  1  0/14 (0.00%)  0 1/14 (7.14%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0
Pneumonia aspiration  1  0/14 (0.00%)