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Pharmacokinetics and PharmacoDynamics of GW685698 in Paedeatric Asthmatic Patients

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: NCT01332292
Recruitment Status : Completed
First Posted : April 11, 2011
Results First Posted : September 16, 2013
Last Update Posted : March 23, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: Fluticasone furoate
Drug: Matching placebo
Enrollment 27
Recruitment Details Participants were enrolled into one of two cohorts based upon age; the younger cohort was enrolled after a review of the safety/pharmacokinetic data of at least six participants from the older cohort. Each participant was assigned to treatment randomly; assignment was not to be influenced by whether participants were in Cohort 1 or Cohort 2.
Pre-assignment Details A Baseline assessment was carried out on Day 1 of the first treatment period. Participants were then randomized to one of the two possible treatment sequences (fluticasone furoate [FF] 100 µg followed by placebo; placebo followed by FF 100 µg). Results are reported by intervention, regardless of the age of the participant.
Arm/Group Title Sequence 1: FF 100 µg Followed by Placebo Sequence 2: Placebo Followed by FF 100 µg
Hide Arm/Group Description Participants received fluticasone furoate (FF) 100 micrograms (µg) in Treatment Period 1 and matching placebo in Treatment Period 2. Inhaled FF 100 µg and matching placebo were administered once daily in the morning (Day 1 to Day 14) via a Dry Powder Inhaler. The washout period between the 14-day treatment periods was at least 7 days. Participants received placebo in Treatment Period 1 and FF 100 µg in Treatment Period 2. Inhaled FF 100 µg and matching placebo were administered once daily in the morning (Day 1 to Day 14) via a Dry Powder Inhaler. The washout period between the 14-day treatment periods was at least 7 days.
Period Title: Treatment Period 1 (14 Days)
Started 14 13
Completed 12 12
Not Completed 2 1
Reason Not Completed
Adverse Event             1             0
Protocol Violation             1             1
Period Title: Washout Period (>=7 Days)
Started 12 12
Completed 12 12
Not Completed 0 0
Period Title: Treatment Period 2 (14 Days)
Started 12 12
Completed 11 11
Not Completed 1 1
Reason Not Completed
Physician Decision             1             1
Arm/Group Title FF 100 µg/Placebo or Placebo/FF 100 µg
Hide Arm/Group Description Participants received either fluticasone furoate (FF) 100 micrograms (µg) or matching placebo in the first of two 14-day treatment periods, followed by the other therapy (the therapy not received in the first treatment period) in the second 14-day treatment period. Inhaled FF 100 µg or matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
Overall Number of Baseline Participants 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants
8.2  (2.08)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Female
13
  48.1%
Male
14
  51.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 27 participants
African American/African Heritage 9
White 16
African American/African Heritage & White 1
Unknown; Child Was Adopted 1
1.Primary Outcome
Title Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period
Hide Description An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs.
Time Frame From the start of study medication until Week 11 (Visit 6)/Early Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population: all participants who received at least one dose of study medication
Arm/Group Title Placebo FF 100 µg
Hide Arm/Group Description:
All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
Overall Number of Participants Analyzed 25 26
Measure Type: Number
Unit of Measure: participants
Any AE 4 8
Any SAE 0 0
2.Primary Outcome
Title Basophil, Eosinophil, Lymphocyte, Monocyte, Total Neutrophil, Platelet, and White Blood Cell Count Values at Day 14 of the Respective Treatment Period
Hide Description Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelets, and white blood cell (WBC) count at Day 14 of the respective treatment period.
Time Frame Day 14 of the respective treatment period (up to Study Day 44)
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
Arm/Group Title Placebo FF 100 µg
Hide Arm/Group Description:
All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
Overall Number of Participants Analyzed 25 26
Mean (Standard Deviation)
Unit of Measure: 10^9 cells per liter (GI/L)
Basophils, n=23, 21 0.022  (0.0153) 0.022  (0.0154)
Eosinophils, n=23, 21 0.308  (0.2204) 0.252  (0.2182)
Lymphocytes, n=23, 21 2.595  (0.7834) 2.430  (0.6563)
Monocytes, n=23, 21 0.280  (0.1669) 0.270  (0.1204)
Total neutrophils, n=23, 21 2.740  (1.2091) 3.209  (1.3103)
Platelets, n=23, 20 266.4  (48.59) 263.3  (55.90)
WBCs, n=23, 21 5.94  (1.696) 6.18  (1.513)
3.Primary Outcome
Title Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Values at Day 14 of the Respective Treatment Period
Hide Description Blood samples were collected for the measurement of hemoglobin and MCHC at Day 14 of the respective treatment period.
Time Frame Day 14 of the respective treatment period (up to Study Day 44)
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
Arm/Group Title Placebo FF 100 µg
Hide Arm/Group Description:
All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Novel Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Novel Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
Overall Number of Participants Analyzed 25 26
Mean (Standard Deviation)
Unit of Measure: Grams per liter (g/L)
Hemoglobin, n=23, 21 129.1  (7.15) 129.6  (6.50)
MCHC, n=23, 21 336.4  (7.66) 336.6  (7.80)
4.Primary Outcome
Title Reticulocyte and Red Blood Cell (RBC) Values at Day 14 of the Respective Treatment Period
Hide Description Blood samples were collected for the measurement of reticulocyte and RBCs at Day 14 of the respective treatment period.
Time Frame Day 14 of the respective treatment period (up to Study Day 44)
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
Arm/Group Title Placebo FF 100 µg
Hide Arm/Group Description:
All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
Overall Number of Participants Analyzed 25 26
Mean (Standard Deviation)
Unit of Measure: 10^12 cells per liter (TI/L)
Reticulocytes, n=23, 21 0.04952  (0.024497) 0.04499  (0.021309)
RBCs, n=23, 21 4.43  (0.277) 4.46  (0.296)
5.Primary Outcome
Title Hematocrit Values at Day 14 of the Respective Treatment Period
Hide Description Blood samples were collected for the measurement of hematocrit at Day 14 of the respective treatment period. Hematocrit is a measure of the percentage of the volume of the whole blood that is composed of red blood cells, as determined by separation of red blood cells from the plasma (usually by centrifugation).
Time Frame Day 14 of the respective treatment period (up to Study Day 44)
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo FF 100 µg
Hide Arm/Group Description:
All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
Overall Number of Participants Analyzed 23 21
Mean (Standard Deviation)
Unit of Measure: percentage of red blood cells in blood
0.3840  (0.02621) 0.3854  (0.02296)
6.Primary Outcome
Title Mean Corpuscle Volume (MCV) Value at Day 14 of the Respective Treatment Period
Hide Description Blood samples were collected for the measurement of MCV at Day 14 of the respective treatment period.
Time Frame Day 14 of the respective treatment period (up to Study Day 44)
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at the specified time points were analyzed .
Arm/Group Title Placebo FF 100 µg
Hide Arm/Group Description:
All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
Overall Number of Participants Analyzed 23 21
Mean (Standard Deviation)
Unit of Measure: 10^15 femtoliters (fL) per cell
86.8  (4.05) 86.9  (4.40)
7.Primary Outcome
Title Mean Corpuscle Hemoglobin (MCH) Values at Day 14 of the Respective Treatment Period
Hide Description Blood samples were collected for the measurement of MCH at Day 14 of the respective treatment period.
Time Frame Day 14 of the respective treatment period (up to Study Day 44)
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo FF 100 µg
Hide Arm/Group Description:
All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
Overall Number of Participants Analyzed 23 21
Mean (Standard Deviation)
Unit of Measure: 10^12 picograms (pg) per cell
29.18  (1.279) 29.24  (1.458)
8.Primary Outcome
Title Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), and Gamma Glutamyl Transferase (GGT) Values at Day 14 of the Respective Treatment Period
Hide Description Blood samples were collected for the measurement of ALT, ALP, AST, and GGT at Day 14 of the respective treatment period.
Time Frame Day 14 of the respective treatment period (up to Study Day 44)
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
Arm/Group Title Placebo FF 100 µg
Hide Arm/Group Description:
All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
Overall Number of Participants Analyzed 25 26
Mean (Standard Deviation)
Unit of Measure: International units per liter (IU/L)
ALT, n=22, 20 12.2  (3.06) 13.0  (6.04)
ALP, n=22, 20 257.8  (59.24) 260.7  (64.15)
AST, n=22, 19 26.8  (4.39) 26.1  (4.53)
GGT, n=22, 20 14.3  (3.58) 15.4  (4.50)
9.Primary Outcome
Title Albumin and Total Protein Values at Day 14 of the Respective Treatment Period
Hide Description Blood samples were collected for the measurement of albumin and total protein at Day 14 of the respective treatment period.
Time Frame Day 14 of the respective treatment period (up to Study Day 44)
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
Arm/Group Title Placebo FF 100 µg
Hide Arm/Group Description:
All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
Overall Number of Participants Analyzed 25 26
Mean (Standard Deviation)
Unit of Measure: Grams per liter
Albumin, n=22, 20 43.0  (2.26) 42.9  (1.83)
Total protein, n=22, 20 67.8  (2.98) 67.8  (2.57)
10.Primary Outcome
Title Calcium, Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 14 of the Respective Treatment Period
Hide Description Blood samples were collected for the measurement of calcium, chloride, carbon dioxide content/bicarbonate (CO2/BI), glucose, potassium, sodium, and urea/BUN at Day 14 of the respective treatment period.
Time Frame Day 14 of the respective treatment period (up to Study Day 44)
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
Arm/Group Title Placebo FF 100 µg
Hide Arm/Group Description:
All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
Overall Number of Participants Analyzed 25 26
Mean (Standard Deviation)
Unit of Measure: Millimoles per liter (mmol/L)
Calcium, n=20, 19 2.371  (0.0791) 2.366  (0.0626)
Chloride, n=22, 20 105.2  (1.93) 104.7  (1.72)
CO2 content/bicarbonate, n=20, 19 17.4  (2.04) 17.8  (1.86)
Glucose, n=22, 20 5.13  (0.614) 4.86  (0.319)
Potassium, n=20, 19 4.24  (0.2564) 4.24  (0.289)
Sodium, n=22, 20 138.3  (1.55) 137.4  (1.54)
Urea/BUN, n=22, 20 4.66  (0.993) 4.83  (1.331)
11.Primary Outcome
Title Total Bilirubin, Creatinine, and Uric Acid Values at Day 14 of the Respective Treatment Period
Hide Description Blood samples were collected for the measurement of total bilirubin, creatinine, and uric acid at Day 14 of the respective treatment period.
Time Frame Day 14 of the respective treatment period (up to Study Day 44)
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
Arm/Group Title Placebo FF 100 µg
Hide Arm/Group Description:
All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
Overall Number of Participants Analyzed 25 26
Mean (Standard Deviation)
Unit of Measure: Micromoles per liter (µmol/L)
Total bilirubin, n= 22, 20 5.9  (2.27) 5.6  (1.23)
Creatinine, n= 22, 20 39.89  (7.775) 40.62  (8.421)
Uric acid, n= 22, 20 237.7  (65.46) 234.5  (70.97)
12.Primary Outcome
Title Peak Expiratory Flow on Day 1 and Day 14 of the Respective Treatment Period
Hide Description Peak Expiratory Flow (PEF) is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF is calculated as the maximum of three readings taken at each timepoint for each participant. Baseline is defined as the maximum pre-dose measurement at Day 1 for each period.
Time Frame Day 1 and Day 14 of the respective treatment period (up to Study Day 44)
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population, Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
Arm/Group Title Placebo FF 100 µg
Hide Arm/Group Description:
All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: liters/minute
Day 1, Baseline, n=25, 25 242.3  (77.68) 238.4  (64.98)
Day 1, 15 minutes post-dose, n=25, 25 242.1  (78.98) 238.2  (58.97)
Day 1, 30 minutes post-dose, n=25, 25 249.2  (78.07) 246.0  (62.65)
Day 1, 1 hour post-dose, n=25, 25 247.7  (72.54) 247.0  (64.75)
Day 1, 2 hours post-dose, n=25, 25 252.3  (89.08) 252.6  (61.77)
Day 14, Pre-dose, n=24, 23 242.0  (73.60) 240.6  (83.88)
Day 14, 30 minutes post-dose, n=23, 23 246.1  (81.17) 238.8  (88.78)
Day 14, 1 hours post-dose, n=23, 23 247.0  (77.95) 237.6  (78.66)
Day 14, 2 hours post-dose, n=23, 23 249.5  (74.09) 242.3  (72.02)
Day 14, 4 hours post-dose, n=23, 23 250.6  (82.43) 246.2  (70.43)
Day 14, 7 hours post-dose, n=23, 23 246.3  (79.07) 232.1  (59.82)
Day 14, 12 hours post-dose, n=23, 23 241.9  (75.80) 245.6  (76.68)
13.Primary Outcome
Title Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Baseline and Day 14 of the Respective Treatment Period
Hide Description SBP and DBP were measured at Baseline and Day 14 of the respective treatment period. Baseline is defined as the pre-dose measurement at Day 1 for each period.
Time Frame Baseline and Day 14 of the respective treatment period (up to Study Day 44)
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
Arm/Group Title Placebo FF 100 µg
Hide Arm/Group Description:
All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
Overall Number of Participants Analyzed 25 26
Mean (Standard Deviation)
Unit of Measure: Millimeters of mercury (mmHg)
Day 1 SBP, Predose, n=25, 26 103.1  (9.29) 102.9  (9.68)
Day 1 SBP, 30 minutes, n=25, 26 101.2  (8.57) 103.8  (10.44)
Day 1 SBP, 1 hour, n=25, 26 102.7  (11.11) 105.2  (11.19)
Day 1 SBP, 2 hours, n=25, 26 102.9  (9.98) 103.9  (9.04)
Day 14 SBP, Predose, n=24, 23 101.8  (8.04) 102.1  (9.92)
Day 14 SBP, 1 hour, n=23, 23 102.6  (9.14) 103.1  (8.04)
Day 14 SBP, 4 hours, n=23, 23 102.0  (9.07) 102.7  (9.43)
Day 14 SBP, 7 hours, n=23, 23 103.4  (9.34) 103.9  (9.88)
Day 14 SBP, 12 hours, n=23, 23 103.2  (7.42) 106.3  (10.61)
Day 1 DBP, Predose, n=25, 26 62.0  (9.71) 61.7  (7.66)
Day 1 DBP, 30 minutes, n=25, 26 63.0  (9.09) 62.6  (6.39)
Day 1 DBP, 1 hour, n=25, 26 61.4  (8.69) 62.3  (8.73)
Day 1 DBP, 2 hours, n=25, 26 63.0  (8.34) 61.2  (8.39)
Day 14 DBP, Predose, n=24, 23 61.3  (6.91) 61.4  (6.81)
Day 14 DBP, 1 hour, n=23, 23 63.9  (10.14) 62.7  (6.88)
Day 14 DBP, 4 hours, n=23, 23 60.4  (8.81) 60.5  (6.73)
Day 14 DBP, 7 hours, n=23, 23 61.8  (9.27) 62.3  (8.23)
Day 14 DBP, 12 hours, n=23, 23 62.0  (8.10) 63.9  (8.68)
14.Primary Outcome
Title Heart Rate at Baseline and Day 14 of the Respective Treatment Period
Hide Description Heart rate (HR) was measured at Baseline and Day 14 of the respective treatment period. Baseline is defined as the pre-dose measurement at Day 1 for each period.
Time Frame Baseline and Day 14 of the respective treatment period (up to Study Day 44)
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
Arm/Group Title Placebo FF 100 µg
Hide Arm/Group Description:
All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
Overall Number of Participants Analyzed 25 26
Mean (Standard Deviation)
Unit of Measure: Beats per minute
Day 1, Baseline, n=25, 26 78.7  (13.18) 75.9  (11.48)
Day 1, 30 minutes, n=25, 26 78.5  (13.99) 75.5  (10.90)
Day 1, 1 hour, n=25, 26 78.6  (12.62) 77.6  (11.49)
Day 1, 2 hours, n=25, 26 80.6  (13.30) 79.6  (11.78)
Day 14, Predose, n=24, 23 76.8  (13.52) 74.5  (10.60)
Day 14, 1 hour, n=23, 23 80.3  (14.76) 76.2  (8.60)
Day 14, 4 hours, n=23, 23 78.2  (10.46) 77.7  (9.77)
Day 14, 7 hours, n=23, 23 83.1  (14.65) 81.2  (12.13)
Day 14, 12 hours, n=23, 23 83.6  (11.70) 81.1  (10.71)
15.Primary Outcome
Title Change From Baseline in the Indicated Electrocardiographic (ECG) Parameters at the Indicated Time Points on Day 14 of the Respective Treatment Period
Hide Description PR, QRS, QT, QTcB, QTcF, and RR were measured at Baseline and Day 14 of the respective treatment period. Baseline is defined as the pre-dose measurement at Day 1 for each period. Change from Baseline was calculated as the value at Day 14 minus the Baseline value. QTcB is the QT duration corrected for heart rate by Bazett’s formula. QTcF is the QT duration corrected for heart rate by Fridericia’s formula.
Time Frame Baseline and Day 14 of the respective treatment period (up to Study Day 44)
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
Arm/Group Title Placebo FF 100 µg
Hide Arm/Group Description:
All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
Overall Number of Participants Analyzed 25 26
Mean (Standard Deviation)
Unit of Measure: milliseconds (msec)
Day 1 PR Interval, 30 minutes, n=25, 26 6.4  (6.37) 7.5  (7.54)
Day 1 PR Interval, 1 hour, n=25, 26 7.3  (6.68) 8.4  (7.17)
Day 1 PR Interval, 2 hours, n=25, 26 8.0  (8.61) 9.5  (10.48)
Day 14 PR Interval, Predose, n=24, 23 7.8  (6.76) 9.6  (9.82)
Day 14 PR Interval, 1 hour, n=23, 23 8.7  (6.74) 8.3  (6.03)
Day 14 PR Interval, 4 hours, n=23, 23 6.4  (3.70) 8.9  (6.86)
Day 14 PR Interval, 7 hour, n=23, 23 8.3  (6.56) 10.2  (10.09)
Day 14 PR Interval, 12 hours, n=22, 23 7.2  (7.50) 9.7  (6.54)
Day 1 QRS Interval, 30 minutes, n=25, 26 4.6  (3.46) 5.2  (4.70)
Day 1 QRS Interval, 1 hour, n=25, 26 4.1  (2.84) 4.4  (3.86)
Day 1 QRS Interval, 2 hours, n=25, 26 4.0  (2.64) 4.5  (3.61)
Day 14 QRS Interval, Predose, n=24, 23 4.2  (3.71) 4.7  (4.29)
Day 14 QRS Interval, 1 hour, n=23, 23 5.7  (3.54) 5.3  (4.71)
Day 14 QRS Interval, 4 hours, n=23, 23 5.6  (3.85) 4.9  (3.93)
Day 14 QRS Interval, 7 hours, n=23, 23 6.1  (5.25) 4.3  (4.22)
Day 14 QRS Interval, 12 hours, n=23, 23 5.0  (4.70) 4.8  (4.02)
Day 1 QT Interval, 30 minutes, n=25, 26 9.8  (8.14) 10.5  (9.57)
Day 1 QT Interval, 1 hour, n=25, 26 13.1  (11.04) 12.7  (11.53)
Day 1 QT Interval, 2 hours, n=25, 26 17.5  (13.88) 15.5  (13.83)
Day 14 QT Interval, Predose, n=24, 23 12.5  (9.81) 15.5  (13.34)
Day 14 QT Interval, 1 hour, n=23, 23 11.4  (6.45) 15.9  (11.11)
Day 14 QT Interval, 4 hours, n=23, 23 13.3  (9.65) 16.7  (12.52)
Day 14 QT Interval, 7 hours, n=23, 23 14.7  (10.94) 15.3  (11.93)
Day 14 QT Interval, 12 hours, n=23, 23 14.7  (10.42) 24.8  (14.93)
Day 1 QTcB Interval, 30 minutes, n=25, 26 15.4  (14.44) 14.2  (11.64)
Day 1 QTcB Interval, 1 hour, n=25, 26 17.3  (13.46) 17.7  (13.18)
Day 1 QTcB Interval, 2 hours, n=25, 26 13.6  (11.07) 18.2  (17.54)
Day 14 QTcB Interval, Predose, n=24, 23 20.7  (15.54) 17.9  (14.92)
Day 14 QTcB Interval, 1 hour, n=23, 23 16.6  (9.43) 16.2  (9.71)
Day 14 QTcB Interval, 4 hours, n=23, 23 14.7  (9.13) 16.8  (9.23)
Day 14 QTcB Interval, 7 hours, n=23, 23 14.5  (10.14) 19.6  (12.03)
Day 14 QTcB Interval, 12 hours, n=23, 23 13.8  (10.70) 18.5  (15.70)
Day 1 QTcF Interval, 30 minutes, n=25, 26 10.8  (9.31) 11.8  (9.30)
Day 1 QTcF Interval, 1 hour, n=25, 26 11.6  (9.57) 12.6  (10.00)
Day 1 QTcF Interval, 2 hours, n=25, 26 10.4  (8.36) 15.4  (12.88)
Day 14 QTcF Interval, Predose, n=24, 23 14.2  (9.92) 12.6  (10.99)
Day 14 QTcF Interval, 1 hour, n=23, 23 9.3  (6.09) 11.4  (9.56)
Day 14 QTcF Interval, 4 hours, n=23, 23 7.8  (6.97) 15.7  (7.41)
Day 14 QTcF Interval, 7 hours, n=23, 23 9.3  (7.77) 15.0  (9.51)
Day 14 QTcF Interval, 12 hours, n=23, 23 8.8  (5.84) 15.8  (11.61)
Day 1 RR Interval, 30 minutes, n=25, 26 70.4  (66.47) 54.2  (44.61)
Day 1 RR Interval, 1 hour, n=25, 26 93.5  (64.97) 90.7  (52.94)
Day 1 RR Interval, 2 hours, n=25, 26 102.0  (61.66) 80.4  (71.51)
Day 14 RR Interval, Predose, n=24, 23 106.0  (73.20) 103.5  (78.48)
Day 14 RR Interval, 1 hour, n=23, 23 92.5  (64.45) 87.7  (63.30)
Day 14 RR Interval, 4 hours, n=23, 23 92.1  (65.93) 63.6  (47.14)
Day 14 RR Interval, 7 hours, n=23, 23 89.6  (63.06) 74.5  (78.18)
Day 14 RR Interval, 12 hours, n=23, 23 94.4  (73.45) 110.3  (101.24)
16.Secondary Outcome
Title AUC(0-t) on Day 14 of the Respective Treatment Period
Hide Description Area under the concentration-time (AUC(0-t)) curve from time zero (pre-dose) to the last time of quantifiable concentration of FF on Day 14 of the respective treatment period was measured. Samples were collected at the following times: pre-dose; 30 minutes, 1, 2, 4, 7, and 12 hours post-dose on Day 14 of the respective treatment period. Due to non-quantifiable values, it was not possible to derive AUC(0-12).
Time Frame Day 14 of the respective treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) Population: all participants in the All Subjects Population for whom a PK sample was obtained and analyzed
Arm/Group Title Placebo FF 100 µg
Hide Arm/Group Description:
All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
Overall Number of Participants Analyzed 0 23
Geometric Mean (95% Confidence Interval)
Unit of Measure: picograms*hour per milliliter (pg*hr/mL)
91.29
(63.24 to 131.78)
17.Secondary Outcome
Title Cmax on Day 14 of the Respective Treatment Period
Hide Description Cmax is defined as the maximum observed concentration on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 30 minutes, 1, 2, 4, 7, and 12 hours post-dose on Day 14 of the respective treatment period.
Time Frame Day 14 of the respective treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population
Arm/Group Title Placebo FF 100 µg
Hide Arm/Group Description:
All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
Overall Number of Participants Analyzed 0 23
Geometric Mean (95% Confidence Interval)
Unit of Measure: picograms per milliliter (pg/mL)
24.68
(20.24 to 30.10)
18.Secondary Outcome
Title Tmax and t at Day 14 of the Respective Treatment Period
Hide Description tmax is defined as the time to reach the observed maximum concentration, and t is defined as the time of the last observed quantifiable concentration on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 30 minutes, 1, 2, 4, 7, and 12 hours post-dose on Day 14 of the respective treatment period.
Time Frame Day 14 of the respective treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participant who had quantifiable FF concentrations were analyzed.
Arm/Group Title Placebo FF 100 µg
Hide Arm/Group Description:
All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
Overall Number of Participants Analyzed 0 22
Mean (Standard Deviation)
Unit of Measure: hours
tmax 0.863  (0.7926)
t 6.953  (4.0875)
19.Secondary Outcome
Title Serum Cortisol Weighted Mean (0–12 Hours) on Day 14 of the Respective Treatment Period
Hide Description Serum cortisol weighted mean was determined for each participant over the time period 0-12 hours on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 30 minutes, 1, 2, 4, 7, and 12 hours post-dose on Day 14 of the respective treatment period.
Time Frame Day 14 of the respective treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at the specified time point were analyzed.
Arm/Group Title Placebo FF 100 µg
Hide Arm/Group Description:
All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
Overall Number of Participants Analyzed 22 23
Geometric Mean (95% Confidence Interval)
Unit of Measure: nanomoles per Liter
178.76
(157.43 to 202.97)
150.41
(132.91 to 170.22)
20.Secondary Outcome
Title Average Oropharyngeal Cross-sectional Area on Days 1 and 14 of the Respective Treatment Period
Hide Description During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for this study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Pharyngometry data were recorded for each day (Days 1 and 14 of the respective treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated.
Time Frame Days 1 and 14 of the respective treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
Arm/Group Title Placebo FF 100 µg
Hide Arm/Group Description:
All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
Overall Number of Participants Analyzed 25 26
Mean (Standard Deviation)
Unit of Measure: centimeters squared (cm^2)
Day 1, n=14, 18 4.06  (1.875) 4.24  (1.677)
Day 14, n= 12, 12 5.49  (1.586) 4.58  (1.497)
21.Secondary Outcome
Title Distance of Assessment on Days 1 and 14 of the Respective Treatment Period
Hide Description During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for this study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Distance of assessment is defined as the distance (length measured in centimeters [cm]) estimated to be from the lips to the larynx. Pharyngometry data were recorded for each day (Days 1 and 14 of each treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated.
Time Frame Days 1 and 14 of the respective treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
Arm/Group Title Placebo FF 100 µg
Hide Arm/Group Description:
All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
Overall Number of Participants Analyzed 25 26
Mean (Standard Deviation)
Unit of Measure: centimeters (cm)
Day 1, n=14, 18 18.63  (1.736) 18.69  (1.432)
Day 14, n= 12, 12 19.37  (1.823) 18.61  (1.942)
22.Secondary Outcome
Title Oropharyngeal Volume on Days 1 and 14 of the Respective Treatment Period
Hide Description During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for this study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Oropharyngeal volume is defined as the volume (cm^3) of the mouth and throat estimated to be from the lips to the larynx. Pharyngometry data were recorded for each day (Days 1 and 14 of the respective treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated.
Time Frame Days 1 and 14 of the respective treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
Arm/Group Title Placebo FF 100 µg
Hide Arm/Group Description:
All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
Overall Number of Participants Analyzed 25 26
Mean (Standard Deviation)
Unit of Measure: cubic centimeters (cm^3)
Day 1, n=14, 18 74.19  (32.402) 78.86  (31.092)
Day 14, n= 12, 12 106.31  (33.188) 86.22  (34.363)
23.Secondary Outcome
Title Average Flow Rate and Peak Inspiratory Flow Rate (PIFR) on Days 1 and 14 of the Respective Treatment Period
Hide Description During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Average flow rate is defined as the average inspiratory flow rate (Liters [L]/min) across the inhalation profile when inhaling across the resistance of the inhaler. PIFR is defined as the Peak Inspiratory Flow Rate (L/min) of the inhalation profile when inhaling across the resistance of the inhaler.The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the average flow rate and PIFR were determined.
Time Frame Day 1 and Day 14 of the respective treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
Arm/Group Title Placebo FF 100 µg
Hide Arm/Group Description:
All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
Overall Number of Participants Analyzed 25 26
Mean (Standard Deviation)
Unit of Measure: Liters per minute (L/min)
Day 1 Average flow rate, n=21, 20 35.38  (11.441) 34.65  (10.840)
Day 14 Average flow rate, n=21, 22 36.25  (11.243) 36.17  (12.772)
Day 1 PIFR, n=21, 20 51.83  (17.286) 52.90  (16.028)
Day 14 PIFR, n=21, 22 55.70  (16.589) 54.76  (17.986)
24.Secondary Outcome
Title Inhalation Time on Days 1 and 14 of the Respective Treatment Period
Hide Description During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Inhalation time is defined as the duration of the inhalation(s) when inhaling across the resistance of the inhaler. The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the inhalation time was determined.
Time Frame Day 1 and Day 14 of the respective treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
Arm/Group Title Placebo FF 100 µg
Hide Arm/Group Description:
All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
Overall Number of Participants Analyzed 25 26
Mean (Standard Deviation)
Unit of Measure: Seconds
Day 1, n=21, 20 1.71  (0.534) 1.93  (0.861)
Day 14, n= 21, 22 1.60  (0.802) 1.61  (0.858)
25.Secondary Outcome
Title Inhaled Volume on Days 1 and 14 of the Respective Treatment Period
Hide Description

During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Inhaled volume is defined as the volume of air (Liters) inhaled during the inhalation across the resistance of the inhaler.

The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the inhalaled volume was determined.

Time Frame Day 1 and Day 14 of the respective treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
Arm/Group Title Placebo FF 100 µg
Hide Arm/Group Description:
All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
Overall Number of Participants Analyzed 25 26
Mean (Standard Deviation)
Unit of Measure: Liters
Day 1, n=21, 20 0.99  (0.461) 1.07  (0.480)
Day 14, n= 21, 22 1.00  (0.580) 0.95  (0.541)
26.Secondary Outcome
Title Peak Pressure Drop on Days 1 and 14 of the Respective Treatment Period
Hide Description During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Peak pressure drop is defined as the maximum pressure drop (kilopascal [kPa]) achieved during inhalation across the resistance of the inhaler. The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was calculated for each day (Days 1 and 14 of the respective treatment period), and used for subsequent modeling and prediction of dose emission attributes.
Time Frame Day 1 and Day 14 of the respective treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
Arm/Group Title Placebo FF 100 µg
Hide Arm/Group Description:
All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
Overall Number of Participants Analyzed 25 26
Mean (Standard Deviation)
Unit of Measure: Kilopascal (kpa)
Day 1, n=21, 20 2.44  (1.630) 2.53  (1.560)
Day 14, n= 21, 22 2.78  (1.543) 2.74  (1.609)
27.Secondary Outcome
Title Total Emitted Dose (TED) on Days 1 and 14 of the Respective Treatment Period
Hide Description The total emitted dose (TED) is defined as the mass (micrograms) of the nominal dose that passes beyond the throat. The recorded inhalation profiles of the participants and the mouth-throat (oropharyngeal) models of the sizes that approximated to pharyngometry measurements of the participants were used in conjunction with the electronic Lung (eLung) for in vitro assessment. The eLung is a breathing simulator that replicates the selected inhalation profile with an active inhaler placed at the lips end of the selected ororpharyngeal model. After the dose is emitted from the inhaler, the analysis and assay of throat deposition and material passing beyond the throat was used to derive the nominal, minimum, and maximum predicted total emitted dose.
Time Frame Day 1 and Day 14 of the respective treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
Arm/Group Title Placebo FF 100 µg
Hide Arm/Group Description:
All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
Overall Number of Participants Analyzed 0 26
Mean (Standard Deviation)
Unit of Measure: micrograms
Day 1, Nominal TED, n=0, 20 85.35  (1.576)
Day 14, Nominal TED, n=0, 22 85.57  (1.857)
Day 1, Minimum TED, n=0, 20 84.84  (1.617)
Day 14, Minimum TED, n=0, 22 85.17  (1.905)
Day 1, Maximum TED, n=0, 20 85.86  (1.639)
Day 14, Maximum TED, n=0, 22 85.97  (1.861)
28.Secondary Outcome
Title Ex-throat Dose (ETD) and ETD <2 Microns on Days 1 and 14 of the Respective Treatment Period
Hide Description The ex-throat dose (ETD) and the “nominal ETD” is the mass (micrograms) of active investigational material that passes beyond the throat, nominal being the mean.The recorded inhalation profiles of the participants and the mouth-throat (oropharyngeal) models of the sizes that approximated to pharyngometry measurements of the participants were used in conjunction with the electronic Lung (eLung) for in vitro assessment. The eLung is a breathing simulator that replicates the selected inhalation profile with an active inhaler placed at the lips end of the selected ororpharyngeal model. After the dose is emitted from the inhaler, the analysis and assay of throat deposition and material passing beyond the throat was used to derive the nominal, minimum, and maximum predicted ETD and ETD <2 microns.
Time Frame Day 1 and Day 14 of the respective treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
Arm/Group Title Placebo FF 100 µg
Hide Arm/Group Description:
All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
Overall Number of Participants Analyzed 0 26
Mean (Standard Deviation)
Unit of Measure: micrograms
Day 1, Nominal ETD, n=0, 17 29.37  (2.874)
Day 14, Nominal ETD, n=0, 12 29.83  (2.528)
Day 1, Minimum ETD, n=0, 17 28.47  (3.241)
Day 14, Minimum ETD, n=0, 12 29.35  (2.664)
Day 1, Maximum ETD, n=0, 17 30.26  (2.598)
Day 14, Maximum ETD, n=0, 12 30.26  (2.472)
Day 1, ETD <2 microns, n=0, 17 5.13  (0.498)
Day 14, ETD <2 microns, n=0, 12 5.07  (0.455)
Day 1, Minimum ETD <2 microns, n=0, 17 4.96  (0.459)
Day 14, Minimum ETD <2 microns, n=0, 12 4.99  (0.448)
Day 1, Maximum ETD <2 microns, n=0, 17 5.30  (0.559)
Day 14, Maximum ETD <2 microns, n=0, 12 5.17  (0.476)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo FF 100 µg
Hide Arm/Group Description All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days. All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
All-Cause Mortality
Placebo FF 100 µg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo FF 100 µg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/26 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo FF 100 µg
Affected / at Risk (%) Affected / at Risk (%)
Total   4/25 (16.00%)   8/26 (30.77%) 
Gastrointestinal disorders     
Abdominal discomfort  1  1/25 (4.00%)  0/26 (0.00%) 
Dyspepsia  1  0/25 (0.00%)  1/26 (3.85%) 
Toothache  1  1/25 (4.00%)  1/26 (3.85%) 
General disorders     
Product taste abnormal  1  1/25 (4.00%)  1/26 (3.85%) 
Pyrexia  1  0/25 (0.00%)  1/26 (3.85%) 
Infections and infestations     
Upper respiratory tract infection  1  1/25 (4.00%)  1/26 (3.85%) 
Acute tonsillitis  1  0/25 (0.00%)  1/26 (3.85%) 
Influenza  1  0/25 (0.00%)  1/26 (3.85%) 
Otitis externa  1  0/25 (0.00%)  1/26 (3.85%) 
Otitis media  1  0/25 (0.00%)  1/26 (3.85%) 
Tooth abscess  1  0/25 (0.00%)  1/26 (3.85%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/25 (4.00%)  0/26 (0.00%) 
Nervous system disorders     
Headache  1  0/25 (0.00%)  3/26 (11.54%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  0/25 (0.00%)  1/26 (3.85%) 
Nasal congestion  1  0/25 (0.00%)  1/26 (3.85%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01332292     History of Changes
Other Study ID Numbers: 102942
First Submitted: October 28, 2010
First Posted: April 11, 2011
Results First Submitted: June 6, 2013
Results First Posted: September 16, 2013
Last Update Posted: March 23, 2017