Safety, Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of Repeat Doses of Inhaled Nemiralisib in Patients With APDS/PASLI

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ClinicalTrials.gov Identifier: NCT02593539

Recruitment Status : Completed

First Posted : November 1, 2015

Results First Posted : June 18, 2021

Last Update Posted : June 18, 2021

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

Study Type	Interventional
Study Design	Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Activated PI3K-delta Syndrome
Intervention	Drug: Nemiralisib
Enrollment	5

Participant Flow

Recruitment Details	This is an open-label study conducted to investigate safety, pharmacokinetics and pharmacodynamics of repeat doses of inhaled nemiralisib (NEMI) in participants with activated phosphoinositide 3-kinase (PI3K) delta syndrome /p110 delta-activating mutation causing senescent T Cells, lymphadenopathy and immunodeficiency (APDS/PASLI)
Pre-assignment Details	Participants received either 1000 mcg NEMI DISKUS or 700 mcg NEMI ELLIPTA or 500 mcg NEMI ELLIPTA. All NEMI DISKUS and NEMI ELLIPTA dose levels were combined as All NEMI treatment group as there was no intent to compare two dose levels or devices. The study had protocol amendments to reflect changes in dose and device administration.


Arm/Group Title	All NEMI
Arm/Group Description	Participants were administered with...
Arm/Group Description	Participants were administered with either NEMI 1000 mcg using DISKUS DPI or NEMI 700 or 500 mcg using ELLIPTA DPI once daily in the morning. NEMI DISKUS and NEMI ELLIPTA were combined as All NEMI treatment group as there was no intent to compare two dose levels or devices.
Period Title: Overall Study
Started	5
Completed	4
Not Completed	1
Reason Not Completed
Adverse Event	1

Baseline Characteristics

Arm/Group Title		All NEMI
Arm/Group Description		Participants were administered with...
Arm/Group Description		Participants were administered with either NEMI 1000 mcg using DISKUS DPI or NEMI 700 or 500 mcg using ELLIPTA DPI once daily in the morning. NEMI DISKUS and NEMI ELLIPTA were combined as All NEMI treatment group as there was no intent to compare two dose levels or devices.
Overall Number of Baseline Participants		5
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	5 participants
		36.6 (12.36)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	5 participants
	Female	3 60.0%
	Male	2 40.0%
Race/Ethnicity, Customized Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	5 participants
	White-White/Caucasian/European Heritage	5 100.0%

Outcome Measures

1.Primary Outcome


Title	Number of Participants With Any Serious Adverse Events (SAEs) and Any Non-serious Adverse Events (Non-SAEs)
Description	An adverse event is any untoward medical occurrence in a clinical stud...
Description	An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations as judged by physician. Number of participants with any SAE and non-SAEs are presented.
Time Frame	Upto 7.5 months

Outcome Measure Data

Analysis Population Description

All Subjects Population consisted of all participants who received at least one dose of the study treatment.


Arm/Group Title	All NEMI
Arm/Group Description:	Participants were administered with...
Arm/Group Description:	Participants were administered with either NEMI 1000 mcg using DISKUS DPI or NEMI 700 or 500 mcg using ELLIPTA DPI once daily in the morning. NEMI DISKUS and NEMI ELLIPTA were combined as All NEMI treatment group as there was no intent to compare two dose levels or devices.
Overall Number of Participants Analyzed	5
Measure Type: Count of Participants Unit of Measure: Participants
Any non-SAE	5 100.0%
Any SAE	0 0.0%

2.Primary Outcome


Title	Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Description	SBP and DBP were measured in participants in a semi-supine position af...
Description	SBP and DBP were measured in participants in a semi-supine position after 5 minutes rest. Baseline value is defined as latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value. Not applicable (NA) indicates that standard deviation could not be calculated as a single participant was analyzed.
Time Frame	Baseline (Day 1 pre-dose) and at Days 14, 28, 56, 83 and 84

Outcome Measure Data

Analysis Population Description

All Subjects Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).


Arm/Group Title		All NEMI
Arm/Group Description:		Participants were administered with...
Arm/Group Description:		Participants were administered with either NEMI 1000 mcg using DISKUS DPI or NEMI 700 or 500 mcg using ELLIPTA DPI once daily in the morning. NEMI DISKUS and NEMI ELLIPTA were combined as All NEMI treatment group as there was no intent to compare two dose levels or devices.
Overall Number of Participants Analyzed		5
Mean (Standard Deviation) Unit of Measure: Millimeters of Mercury (mmHg)
DBP, Day 14, n= 5	Number Analyzed	5 participants
DBP, Day 14, n= 5		1.0 (6.44)
DBP, Day 28, n= 4	Number Analyzed	4 participants
DBP, Day 28, n= 4		4.0 (6.98)
DBP, Day 56, n= 4	Number Analyzed	4 participants
DBP, Day 56, n= 4		8.5 (5.80)
DBP, Day 83, n= 4	Number Analyzed	4 participants
DBP, Day 83, n= 4		2.0 (4.40)
DBP, Day 84 n= 1	Number Analyzed	1 participants
DBP, Day 84 n= 1		17.0 ^[1] (NA)
SBP, Day 14, n= 5	Number Analyzed	5 participants
SBP, Day 14, n= 5		-1.0 (3.67)
SBP, Day 28, n= 4	Number Analyzed	4 participants
SBP, Day 28, n= 4		5.3 (8.54)
SBP, Day 56, n= 4	Number Analyzed	4 participants
SBP, Day 56, n= 4		10.0 (9.31)
SBP, Day 83, n= 4	Number Analyzed	4 participants
SBP, Day 83, n= 4		1.5 (3.51)
SBP, Day 84, n= 1	Number Analyzed	1 participants
SBP, Day 84, n= 1		16.0 ^[1] (NA)

[1]

NA indicates that standard deviation could not be calculated as a single participant was analyzed.

3.Primary Outcome


Title	Change From Baseline in Pulse Rate
Description	Pulse rate was measured in participants in a semi-supine position afte...
Description	Pulse rate was measured in participants in a semi-supine position after 5 minutes rest. Baseline value is defined as latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value. NA indicates that standard deviation could not be calculated as a single participant was analyzed.
Time Frame	Baseline (Day 1 pre-dose) and at Days 14, 28, 56, 83 and 84

Outcome Measure Data

Analysis Population Description

All Subjects Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).


Arm/Group Title		All NEMI
Arm/Group Description:		Participants were administered with...
Arm/Group Description:		Participants were administered with either NEMI 1000 mcg using DISKUS DPI or NEMI 700 or 500 mcg using ELLIPTA DPI once daily in the morning. NEMI DISKUS and NEMI ELLIPTA were combined as All NEMI treatment group as there was no intent to compare two dose levels or devices.
Overall Number of Participants Analyzed		5
Mean (Standard Deviation) Unit of Measure: Beats per minute
Day 14, n= 5	Number Analyzed	5 participants
Day 14, n= 5		3.2 (7.73)
Day 28, n= 4	Number Analyzed	4 participants
Day 28, n= 4		2.0 (10.86)
Day 56, n= 4	Number Analyzed	4 participants
Day 56, n= 4		6.8 (9.43)
Day 83, n= 4	Number Analyzed	4 participants
Day 83, n= 4		4.8 (7.76)
Day 84 n= 1	Number Analyzed	1 participants
Day 84 n= 1		7.0 ^[1] (NA)

[1]

NA indicates that standard deviation could not be calculated as a single participant was analyzed.

4.Primary Outcome


Title	Change From Baseline in Respiratory Rate
Description	Respiratory rate was measured in participants in a semi-supine positio...
Description	Respiratory rate was measured in participants in a semi-supine position after 5 minutes rest. . Baseline value is defined as latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value. NA indicates that standard deviation could not be calculated as a single participant was analyzed.
Time Frame	Baseline (Day 1 pre-dose) and at Days 14, 28, 56, 83 and 84

Outcome Measure Data

Analysis Population Description

All Subjects Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).


Arm/Group Title		All NEMI
Arm/Group Description:		Participants were administered with...
Arm/Group Description:		Participants were administered with either NEMI 1000 mcg using DISKUS DPI or NEMI 700 or 500 mcg using ELLIPTA DPI once daily in the morning. NEMI DISKUS and NEMI ELLIPTA were combined as All NEMI treatment group as there was no intent to compare two dose levels or devices.
Overall Number of Participants Analyzed		5
Mean (Standard Deviation) Unit of Measure: Breaths per minute
Day 14, n= 5	Number Analyzed	5 participants
Day 14, n= 5		0.2 (2.28)
Day 28, n= 4	Number Analyzed	4 participants
Day 28, n= 4		0.8 (4.57)
Day 56, n= 4	Number Analyzed	4 participants
Day 56, n= 4		1.5 (5.26)
Day 83, n= 4	Number Analyzed	4 participants
Day 83, n= 4		1.0 (2.45)
Day 84 n= 1	Number Analyzed	1 participants
Day 84 n= 1		2.0 ^[1] (NA)

[1]

NA indicates that standard deviation could not be calculated as a single participant was analyzed.

5.Primary Outcome


Title	Change From Baseline in Body Temperature
Description	Temperature was measured in participants in a semi-supine position aft...
Description	Temperature was measured in participants in a semi-supine position after 5 minutes rest. Baseline value is defined as latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value. NA indicates that standard deviation could not be calculated as a single participant was analyzed.
Time Frame	Baseline (Day 1 pre-dose) and at Days 14, 28, 56, 83 and 84

Outcome Measure Data

Analysis Population Description

All Subjects Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).


Arm/Group Title		All NEMI
Arm/Group Description:		Participants were administered with...
Arm/Group Description:		Participants were administered with either NEMI 1000 mcg using DISKUS DPI or NEMI 700 or 500 mcg using ELLIPTA DPI once daily in the morning. NEMI DISKUS and NEMI ELLIPTA were combined as All NEMI treatment group as there was no intent to compare two dose levels or devices.
Overall Number of Participants Analyzed		5
Mean (Standard Deviation) Unit of Measure: Degrees celsius
Day 14, n= 5	Number Analyzed	5 participants
Day 14, n= 5		0.10 (0.158)
Day 28, n= 4	Number Analyzed	4 participants
Day 28, n= 4		0.17 (0.350)
Day 56, n= 4	Number Analyzed	4 participants
Day 56, n= 4		0.07 (0.171)
Day 83, n= 4	Number Analyzed	4 participants
Day 83, n= 4		0.17 (0.479)
Day 84 n= 1	Number Analyzed	1 participants
Day 84 n= 1		0.50 ^[1] (NA)

[1]

NA indicates that standard deviation could not be calculated as a single participant was analyzed.

6.Primary Outcome


Title	Change From Baseline in Electrocardiogram (ECG) Mean Heart Rate
Description	Single 12-lead ECGs were recorded at indicated timepoints using an ECG...
Description	Single 12-lead ECGs were recorded at indicated timepoints using an ECG machine that automatically calculated the heart rate. Baseline value is defined as latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1 pre-dose) and at Days 14, 28, 56 and 83

Outcome Measure Data

Analysis Population Description

All Subjects Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).


Arm/Group Title		All NEMI
Arm/Group Description:		Participants were administered with...
Arm/Group Description:		Participants were administered with either NEMI 1000 mcg using DISKUS DPI or NEMI 700 or 500 mcg using ELLIPTA DPI once daily in the morning. NEMI DISKUS and NEMI ELLIPTA were combined as All NEMI treatment group as there was no intent to compare two dose levels or devices.
Overall Number of Participants Analyzed		5
Mean (Standard Deviation) Unit of Measure: Beats per minute
Day 14, n= 5	Number Analyzed	5 participants
Day 14, n= 5		-1.0 (3.94)
Day 28, n= 4	Number Analyzed	4 participants
Day 28, n= 4		-0.8 (2.99)
Day 56, n= 4	Number Analyzed	4 participants
Day 56, n= 4		5.3 (7.54)
Day 83, n= 4	Number Analyzed	4 participants
Day 83, n= 4		1.0 (2.31)

7.Primary Outcome


Title	Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia Interval (QTcF) and QTc Corrected by Bazett's Formula (QTcB)
Description	Twelve lead ECGs were recorded at indicated timepoints. At each time p...
Description	Twelve lead ECGs were recorded at indicated timepoints. At each time point, ECG machine automatically measured QRS duration, uncorrected QT interval, QTcF interval and QTcB. Baseline value is defined as latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1 pre-dose) and at Days 14, 28, 56 and 83

Outcome Measure Data

Analysis Population Description

All Subjects Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).


Arm/Group Title		All NEMI
Arm/Group Description:		Participants were administered with...
Arm/Group Description:		Participants were administered with either NEMI 1000 mcg using DISKUS DPI or NEMI 700 or 500 mcg using ELLIPTA DPI once daily in the morning. NEMI DISKUS and NEMI ELLIPTA were combined as All NEMI treatment group as there was no intent to compare two dose levels or devices.
Overall Number of Participants Analyzed		5
Mean (Standard Deviation) Unit of Measure: Milliseconds
PR, Day 14, n= 5	Number Analyzed	5 participants
PR, Day 14, n= 5		-2.2 (9.23)
PR, Day 28, n= 4	Number Analyzed	4 participants
PR, Day 28, n= 4		-4.8 (4.27)
PR, Day 56, n= 4	Number Analyzed	4 participants
PR, Day 56, n= 4		-3.3 (11.18)
PR, Day 83, n= 4	Number Analyzed	4 participants
PR, Day 83, n= 4		-6.0 (11.80)
QRS Duration, Day 14, n= 5	Number Analyzed	5 participants
QRS Duration, Day 14, n= 5		-5.6 (7.33)
QRS Duration, Day 28, n= 4	Number Analyzed	4 participants
QRS Duration, Day 28, n= 4		-4.5 (11.03)
QRS Duration, Day 56, n= 4	Number Analyzed	4 participants
QRS Duration, Day 56, n= 4		-6.5 (8.81)
QRS Duration, Day 83, n= 4	Number Analyzed	4 participants
QRS Duration, Day 83, n= 4		-6.0 (7.79)
QT Interval, Day 14, n= 5	Number Analyzed	5 participants
QT Interval, Day 14, n= 5		-7.2 (10.66)
QT Interval, Day 28, n= 4	Number Analyzed	4 participants
QT Interval, Day 28, n= 4		-2.8 (28.89)
QT Interval, Day 56, n= 4	Number Analyzed	4 participants
QT Interval, Day 56, n= 4		-22.3 (16.01)
QT Interval, Day 83, n= 4	Number Analyzed	4 participants
QT Interval, Day 83, n= 4		-16.3 (9.74)
QTcB, Day 14, n= 5	Number Analyzed	5 participants
QTcB, Day 14, n= 5		-9.4 (4.93)
QTcB, Day 28, n= 4	Number Analyzed	4 participants
QTcB, Day 28, n= 4		-4.5 (22.55)
QTcB, Day 56, n= 4	Number Analyzed	4 participants
QTcB, Day 56, n= 4		-8.3 (24.55)
QTcB, Day 83, n= 4	Number Analyzed	4 participants
QTcB, Day 83, n= 4		-12.5 (8.19)
QTcF, Day 14, n= 5	Number Analyzed	5 participants
QTcF, Day 14, n= 5		-8.2 (4.32)
QTcF, Day 28, n= 4	Number Analyzed	4 participants
QTcF, Day 28, n= 4		-3.5 (24.09)
QTcF, Day 56, n= 4	Number Analyzed	4 participants
QTcF, Day 56, n= 4		-13.0 (19.92)
QTcF, Day 83, n= 4	Number Analyzed	4 participants
QTcF, Day 83, n= 4		-14.0 (7.79)

8.Primary Outcome


Title	Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
Description	Blood samples were collected for the analysis of clinical parameters i...
Description	Blood samples were collected for the analysis of clinical parameters including ALT, ALP and AST. Baseline value is defined as latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day -1) and at Days 14, 28, 56 and 83

Outcome Measure Data

Analysis Population Description

All Subjects Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).


Arm/Group Title		All NEMI
Arm/Group Description:		Participants were administered with...
Arm/Group Description:		Participants were administered with either NEMI 1000 mcg using DISKUS DPI or NEMI 700 or 500 mcg using ELLIPTA DPI once daily in the morning. NEMI DISKUS and NEMI ELLIPTA were combined as All NEMI treatment group as there was no intent to compare two dose levels or devices.
Overall Number of Participants Analyzed		5
Mean (Standard Deviation) Unit of Measure: International units per liter (IU/L)
ALT, Day 14, n= 5	Number Analyzed	5 participants
ALT, Day 14, n= 5		1.0 (2.12)
ALT, Day 28, n= 4	Number Analyzed	4 participants
ALT, Day 28, n= 4		0.8 (1.71)
ALT, Day 56, n= 4	Number Analyzed	4 participants
ALT, Day 56, n= 4		0.0 (1.63)
ALT, Day 83, n= 4	Number Analyzed	4 participants
ALT, Day 83, n= 4		1.3 (7.50)
AST, Day 14, n= 5	Number Analyzed	5 participants
AST, Day 14, n= 5		-0.8 (1.48)
AST, Day 28, n= 4	Number Analyzed	4 participants
AST, Day 28, n= 4		0.8 (2.22)
AST, Day 56, n= 4	Number Analyzed	4 participants
AST, Day 56, n= 4		-0.8 (4.79)
AST, Day 83, n= 4	Number Analyzed	4 participants
AST, Day 83, n= 4		-1.0 (7.70)
ALP, Day 14, n= 5	Number Analyzed	5 participants
ALP, Day 14, n= 5		2.6 (5.77)
ALP, Day 28, n= 4	Number Analyzed	4 participants
ALP, Day 28, n= 4		3.8 (5.68)
ALP, Day 56, n= 4	Number Analyzed	4 participants
ALP, Day 56, n= 4		7.5 (5.00)
ALP, Day 83, n= 4	Number Analyzed	4 participants
ALP, Day 83, n= 4		6.0 (2.94)

9.Primary Outcome


Title	Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein
Description	Blood samples were collected for the analysis of clinical chemistry pa...
Description	Blood samples were collected for the analysis of clinical chemistry parameter-albumin and total protein. Baseline value is defined as latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day -1) and at Days 14, 28, 56 and 83

Outcome Measure Data

Analysis Population Description

All Subjects Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).


Arm/Group Title		All NEMI
Arm/Group Description:		Participants were administered with...
Arm/Group Description:		Participants were administered with either NEMI 1000 mcg using DISKUS DPI or NEMI 700 or 500 mcg using ELLIPTA DPI once daily in the morning. NEMI DISKUS and NEMI ELLIPTA were combined as All NEMI treatment group as there was no intent to compare two dose levels or devices.
Overall Number of Participants Analyzed		5
Mean (Standard Deviation) Unit of Measure: Grams per liter
Albumin, Day 14, n= 5	Number Analyzed	5 participants
Albumin, Day 14, n= 5		2.6 (2.07)
Albumin, Day 28, n= 4	Number Analyzed	4 participants
Albumin, Day 28, n= 4		1.3 (3.20)
Albumin, Day 56, n= 4	Number Analyzed	4 participants
Albumin, Day 56, n= 4		2.8 (2.36)
Albumin, Day 83, n= 4	Number Analyzed	4 participants
Albumin, Day 83, n= 4		2.0 (3.16)
Total Protein, Day 14, n= 5	Number Analyzed	5 participants
Total Protein, Day 14, n= 5		4.0 (1.58)
Total Protein, Day 28, n= 4	Number Analyzed	4 participants
Total Protein, Day 28, n= 4		1.3 (3.59)
Total Protein, Day 56, n= 4	Number Analyzed	4 participants
Total Protein, Day 56, n= 4		4.0 (4.76)
Total Protein, Day 83, n= 4	Number Analyzed	4 participants
Total Protein, Day 83, n= 4		4.3 (2.50)

10.Primary Outcome


Title	Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose and Urea
Description	Blood samples were collected for the analysis of clinical parameters i...
Description	Blood samples were collected for the analysis of clinical parameters including sodium, potassium, calcium, glucose and urea. Baseline value is defined as latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day -1) and at Days 14, 28, 56 and 83

Outcome Measure Data

Analysis Population Description

All Subjects Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).


Arm/Group Title		All NEMI
Arm/Group Description:		Participants were administered with...
Arm/Group Description:		Participants were administered with either NEMI 1000 mcg using DISKUS DPI or NEMI 700 or 500 mcg using ELLIPTA DPI once daily in the morning. NEMI DISKUS and NEMI ELLIPTA were combined as All NEMI treatment group as there was no intent to compare two dose levels or devices.
Overall Number of Participants Analyzed		5
Mean (Standard Deviation) Unit of Measure: Millimoles per liter
Sodium, Day 14, n= 5	Number Analyzed	5 participants
Sodium, Day 14, n= 5		-0.2 (2.68)
Sodium, Day 28, n= 4	Number Analyzed	4 participants
Sodium, Day 28, n= 4		0.5 (0.58)
Sodium, Day 56, n= 4	Number Analyzed	4 participants
Sodium, Day 56, n= 4		-0.8 (2.06)
Sodium, Day 83, n= 4	Number Analyzed	4 participants
Sodium, Day 83, n= 4		0.0 (1.83)
Potassium, Day 14, n= 5	Number Analyzed	5 participants
Potassium, Day 14, n= 5		0.24 (0.397)
Potassium, Day 28, n= 4	Number Analyzed	4 participants
Potassium, Day 28, n= 4		0.30 (0.346)
Potassium, Day 56, n= 4	Number Analyzed	4 participants
Potassium, Day 56, n= 4		0.35 (0.370)
Potassium, Day 83, n= 4	Number Analyzed	4 participants
Potassium, Day 83, n= 4		0.38 (0.275)
Calcium, Day 14, n= 5	Number Analyzed	5 participants
Calcium, Day 14, n= 5		0.040 (0.0990)
Calcium, Day 28, n= 4	Number Analyzed	4 participants
Calcium, Day 28, n= 4		0.063 (0.0704)
Calcium, Day 56, n= 4	Number Analyzed	4 participants
Calcium, Day 56, n= 4		0.133 (0.1343)
Calcium, Day 83, n= 4	Number Analyzed	4 participants
Calcium, Day 83, n= 4		0.082 (0.1325)
Glucose, Day 14, n= 5	Number Analyzed	5 participants
Glucose, Day 14, n= 5		-0.64 (1.557)
Glucose, Day 28, n= 4	Number Analyzed	4 participants
Glucose, Day 28, n= 4		-0.60 (1.774)
Glucose, Day 56, n= 4	Number Analyzed	4 participants
Glucose, Day 56, n= 4		-0.48 (1.578)
Glucose, Day 83, n= 4	Number Analyzed	4 participants
Glucose, Day 83, n= 4		-0.68 (1.333)
Urea, Day 14, n= 5	Number Analyzed	5 participants
Urea, Day 14, n= 5		4.732 (5.8283)
Urea, Day 28, n= 4	Number Analyzed	4 participants
Urea, Day 28, n= 4		8.330 (2.6837)
Urea, Day 56, n= 4	Number Analyzed	4 participants
Urea, Day 56, n= 4		2.610 (5.1954)
Urea, Day 83, n= 4	Number Analyzed	4 participants
Urea, Day 83, n= 4		2.185 (4.1025)

11.Primary Outcome


Title	Change From Baseline Values in Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine
Description	Blood samples were collected for the analysis of clinical chemistry pa...
Description	Blood samples were collected for the analysis of clinical chemistry parameters: direct bilirubin, total bilirubin and creatinine. Baseline value is defined as latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day -1) and at Days 14, 28, 56 and 83

Outcome Measure Data

Analysis Population Description

All Subjects Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).


Arm/Group Title		All NEMI
Arm/Group Description:		Participants were administered with...
Arm/Group Description:		Participants were administered with either NEMI 1000 mcg using DISKUS DPI or NEMI 700 or 500 mcg using ELLIPTA DPI once daily in the morning. NEMI DISKUS and NEMI ELLIPTA were combined as All NEMI treatment group as there was no intent to compare two dose levels or devices.
Overall Number of Participants Analyzed		5
Mean (Standard Deviation) Unit of Measure: Micromoles per liter
Direct bilirubin, Day 14, n= 5	Number Analyzed	5 participants
Direct bilirubin, Day 14, n= 5		-1.0 (0.71)
Direct bilirubin, Day 28, n= 4	Number Analyzed	4 participants
Direct bilirubin, Day 28, n= 4		-1.8 (0.96)
Direct bilirubin, Day 56, n= 4	Number Analyzed	4 participants
Direct bilirubin, Day 56, n= 4		-0.5 (1.00)
Direct bilirubin, Day 83, n= 4	Number Analyzed	4 participants
Direct bilirubin, Day 83, n= 4		-0.5 (1.00)
Total bilirubin, Day 14, n= 5	Number Analyzed	5 participants
Total bilirubin, Day 14, n= 5		-1.8 (1.64)
Total bilirubin, Day 28, n= 4	Number Analyzed	4 participants
Total bilirubin, Day 28, n= 4		-3.0 (2.45)
Total bilirubin, Day 56, n= 4	Number Analyzed	4 participants
Total bilirubin, Day 56, n= 4		-0.8 (1.89)
Total bilirubin, Day 83, n= 4	Number Analyzed	4 participants
Total bilirubin, Day 83, n= 4		-1.5 (2.52)
Creatinine , Day 14, n= 5	Number Analyzed	5 participants
Creatinine , Day 14, n= 5		-2.0 (12.43)
Creatinine , Day 28, n= 4	Number Analyzed	4 participants
Creatinine , Day 28, n= 4		-4.3 (6.08)
Creatinine , Day 56, n= 4	Number Analyzed	4 participants
Creatinine , Day 56, n= 4		5.0 (14.07)
Creatinine , Day 83, n= 4	Number Analyzed	4 participants
Creatinine , Day 83, n= 4		-2.5 (14.93)

12.Primary Outcome


Title	Change From Baseline Values in Clinical Chemistry Parameter: C-Reactive Protein
Description	Blood samples were collected for the analysis of clinical chemistry pa...
Description	Blood samples were collected for the analysis of clinical chemistry parameter:C-Reactive Protein. Baseline value is defined as latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1 pre-dose) and at Days 14, 28, 56 and 83

Outcome Measure Data

Analysis Population Description

All Subjects Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).


Arm/Group Title		All NEMI
Arm/Group Description:		Participants were administered with...
Arm/Group Description:		Participants were administered with either NEMI 1000 mcg using DISKUS DPI or NEMI 700 or 500 mcg using ELLIPTA DPI once daily in the morning. NEMI DISKUS and NEMI ELLIPTA were combined as All NEMI treatment group as there was no intent to compare two dose levels or devices.
Overall Number of Participants Analyzed		5
Mean (Standard Deviation) Unit of Measure: Milligrams per liter
Day 14, n= 5	Number Analyzed	5 participants
Day 14, n= 5		0.56 (1.592)
Day 28, n= 4	Number Analyzed	4 participants
Day 28, n= 4		0.75 (1.085)
Day 56, n= 4	Number Analyzed	4 participants
Day 56, n= 4		2.75 (6.222)
Day 83, n= 4	Number Analyzed	4 participants
Day 83, n= 4		3.90 (7.141)

13.Primary Outcome


Title	Change From Baseline for Hematology Parameters: Basophil, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes and Platelets
Description	Blood samples were collected for the analysis of hematology parameters...
Description	Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, WBC, lymphocytes, neutrophils, monocytes and platelets at indicated timepoints. Baseline value is defined as latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day -1) and at Days 14, 28, 56 and 83

Outcome Measure Data

Analysis Population Description

All Subjects Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).


Arm/Group Title		All NEMI
Arm/Group Description:		Participants were administered with...
Arm/Group Description:		Participants were administered with either NEMI 1000 mcg using DISKUS DPI or NEMI 700 or 500 mcg using ELLIPTA DPI once daily in the morning. NEMI DISKUS and NEMI ELLIPTA were combined as All NEMI treatment group as there was no intent to compare two dose levels or devices.
Overall Number of Participants Analyzed		5
Mean (Standard Deviation) Unit of Measure: 10^9 cells per liters
Basophils, Day 14, n= 5	Number Analyzed	5 participants
Basophils, Day 14, n= 5		-0.002 (0.0045)
Basophils, Day 28, n= 4	Number Analyzed	4 participants
Basophils, Day 28, n= 4		0.008 (0.0096)
Basophils, Day 56, n= 4	Number Analyzed	4 participants
Basophils, Day 56, n= 4		0.008 (0.0236)
Basophils, Day 83, n= 4	Number Analyzed	4 participants
Basophils, Day 83, n= 4		0.013 (0.0222)
Eosinophils, Day 14, n= 5	Number Analyzed	5 participants
Eosinophils, Day 14, n= 5		0.108 (0.1542)
Eosinophils, Day 28, n= 4	Number Analyzed	4 participants
Eosinophils, Day 28, n= 4		0.088 (0.0650)
Eosinophils, Day 56, n= 4	Number Analyzed	4 participants
Eosinophils, Day 56, n= 4		0.128 (0.2241)
Eosinophils, Day 83, n= 4	Number Analyzed	4 participants
Eosinophils, Day 83, n= 4		0.075 (0.0810)
Lymphocytes, Day 14, n= 5	Number Analyzed	5 participants
Lymphocytes, Day 14, n= 5		0.122 (0.2411)
Lymphocytes, Day 28, n= 4	Number Analyzed	4 participants
Lymphocytes, Day 28, n= 4		-0.133 (0.0918)
Lymphocytes, Day 56, n= 4	Number Analyzed	4 participants
Lymphocytes, Day 56, n= 4		-0.105 (0.1115)
Lymphocytes, Day 83, n= 4	Number Analyzed	4 participants
Lymphocytes, Day 83, n= 4		0.037 (0.3140)
Monocytes, Day 14, n= 5	Number Analyzed	5 participants
Monocytes, Day 14, n= 5		0.096 (0.2893)
Monocytes, Day 28, n= 4	Number Analyzed	4 participants
Monocytes, Day 28, n= 4		0.030 (0.0572)
Monocytes, Day 56, n= 4	Number Analyzed	4 participants
Monocytes, Day 56, n= 4		0.115 (0.0614)
Monocytes, Day 83, n= 4	Number Analyzed	4 participants
Monocytes, Day 83, n= 4		0.065 (0.0592)
Neutrophils , Day 14, n= 5	Number Analyzed	5 participants
Neutrophils , Day 14, n= 5		0.334 (1.2388)
Neutrophils , Day 28, n= 4	Number Analyzed	4 participants
Neutrophils , Day 28, n= 4		0.575 (0.6125)
Neutrophils , Day 56, n= 4	Number Analyzed	4 participants
Neutrophils , Day 56, n= 4		0.553 (0.7647)
Neutrophils , Day 83, n= 4	Number Analyzed	4 participants
Neutrophils , Day 83, n= 4		0.653 (0.7857)
Platelet, Day 14, n= 5	Number Analyzed	5 participants
Platelet, Day 14, n= 5		49.4 (52.53)
Platelet, Day 28, n= 4	Number Analyzed	4 participants
Platelet, Day 28, n= 4		9.0 (25.86)
Platelet, Day 56, n= 4	Number Analyzed	4 participants
Platelet, Day 56, n= 4		17.0 (31.79)
Platelet, Day 83, n= 4	Number Analyzed	4 participants
Platelet, Day 83, n= 4		61.8 (43.41)
WBC, Day 14, n= 5	Number Analyzed	5 participants
WBC, Day 14, n= 5		0.656 (1.0304)
WBC, Day 28, n= 4	Number Analyzed	4 participants
WBC, Day 28, n= 4		0.568 (0.6004)
WBC, Day 56, n= 4	Number Analyzed	4 participants
WBC, Day 56, n= 4		0.698 (1.0605)
WBC, Day 83, n= 4	Number Analyzed	4 participants
WBC, Day 83, n= 4		0.845 (0.6608)

14.Primary Outcome


Title	Change From Baseline for Hematology Parameter: Hemoglobin
Description	Blood samples were collected for the analysis of hematology parameter:...
Description	Blood samples were collected for the analysis of hematology parameter: hemoglobin at indicated timepoints. Baseline value is defined as latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1 pre-dose) and at Days 14, 28, 56 and 83

Outcome Measure Data

Analysis Population Description

All Subjects Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).


Arm/Group Title		All NEMI
Arm/Group Description:		Participants were administered with...
Arm/Group Description:		Participants were administered with either NEMI 1000 mcg using DISKUS DPI or NEMI 700 or 500 mcg using ELLIPTA DPI once daily in the morning. NEMI DISKUS and NEMI ELLIPTA were combined as All NEMI treatment group as there was no intent to compare two dose levels or devices.
Overall Number of Participants Analyzed		5
Mean (Standard Deviation) Unit of Measure: Grams per liter
Day 14, n= 5	Number Analyzed	5 participants
Day 14, n= 5		10.0 (5.24)
Day 28, n= 4	Number Analyzed	4 participants
Day 28, n= 4		8.3 (3.77)
Day 56, n= 4	Number Analyzed	4 participants
Day 56, n= 4		13.5 (8.50)
Day 83, n= 4	Number Analyzed	4 participants
Day 83, n= 4		13.3 (5.74)

15.Primary Outcome


Title	Change From Baseline for Hematology Parameter: Hematocrit
Description	Blood samples were collected for the analysis of hematology parameter:...
Description	Blood samples were collected for the analysis of hematology parameter: hematocrit at indicated timepoints. Baseline value is defined as latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1 pre-dose) and at Days 14, 28, 56 and 83

Outcome Measure Data

Analysis Population Description

All Subjects Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).


Arm/Group Title		All NEMI
Arm/Group Description:		Participants were administered with...
Arm/Group Description:		Participants were administered with either NEMI 1000 mcg using DISKUS DPI or NEMI 700 or 500 mcg using ELLIPTA DPI once daily in the morning. NEMI DISKUS and NEMI ELLIPTA were combined as All NEMI treatment group as there was no intent to compare two dose levels or devices.
Overall Number of Participants Analyzed		5
Mean (Standard Deviation) Unit of Measure: Percentage of red blood cells in blood
Day 14, n= 5	Number Analyzed	5 participants
Day 14, n= 5		0.0320 (0.01488)
Day 28, n= 4	Number Analyzed	4 participants
Day 28, n= 4		0.0333 (0.01204)
Day 56, n= 4	Number Analyzed	4 participants
Day 56, n= 4		0.0518 (0.02337)
Day 83, n= 4	Number Analyzed	4 participants
Day 83, n= 4		0.0465 (0.01396)

16.Primary Outcome


Title	Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV)
Description	Blood samples were collected for the analysis of hematology parameter:...
Description	Blood samples were collected for the analysis of hematology parameter: MCV at indicated timepoints. Baseline value is defined as latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1 pre-dose) and at Days 14, 28, 56 and 83

Outcome Measure Data

Analysis Population Description

All Subjects Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).


Arm/Group Title		All NEMI
Arm/Group Description:		Participants were administered with...
Arm/Group Description:		Participants were administered with either NEMI 1000 mcg using DISKUS DPI or NEMI 700 or 500 mcg using ELLIPTA DPI once daily in the morning. NEMI DISKUS and NEMI ELLIPTA were combined as All NEMI treatment group as there was no intent to compare two dose levels or devices.
Overall Number of Participants Analyzed		5
Mean (Standard Deviation) Unit of Measure: Femtoliters
Day 14, n= 5	Number Analyzed	5 participants
Day 14, n= 5		1.00 (2.187)
Day 28, n= 4	Number Analyzed	4 participants
Day 28, n= 4		2.33 (2.287)
Day 56, n= 4	Number Analyzed	4 participants
Day 56, n= 4		2.02 (2.331)
Day 83, n= 4	Number Analyzed	4 participants
Day 83, n= 4		1.03 (3.407)

17.Primary Outcome


Title	Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
Description	Blood samples were collected for the analysis of hematology parameters...
Description	Blood samples were collected for the analysis of hematology parameters including MCH at indicated timepoints. Baseline value is defined as latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1 pre-dose) and at Days 14, 28, 56 and 83

Outcome Measure Data

Analysis Population Description

All Subjects Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).


Arm/Group Title		All NEMI
Arm/Group Description:		Participants were administered with...
Arm/Group Description:		Participants were administered with either NEMI 1000 mcg using DISKUS DPI or NEMI 700 or 500 mcg using ELLIPTA DPI once daily in the morning. NEMI DISKUS and NEMI ELLIPTA were combined as All NEMI treatment group as there was no intent to compare two dose levels or devices.
Overall Number of Participants Analyzed		5
Mean (Standard Deviation) Unit of Measure: Picograms
Day 14, n= 5	Number Analyzed	5 participants
Day 14, n= 5		0.10 (0.485)
Day 28, n= 4	Number Analyzed	4 participants
Day 28, n= 4		-0.15 (0.676)
Day 56, n= 4	Number Analyzed	4 participants
Day 56, n= 4		-0.43 (0.763)
Day 83, n= 4	Number Analyzed	4 participants
Day 83, n= 4		-0.47 (0.525)

18.Primary Outcome


Title	Change From Baseline for Hematology Parameter: Red Blood Cell Count
Description	Blood samples were collected for the analysis of hematology parameter:...
Description	Blood samples were collected for the analysis of hematology parameter: Blood Cell Count at indicated timepoints. Baseline value is defined as latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1 pre-dose) and at Days 14, 28, 56 and 83

Outcome Measure Data

Analysis Population Description

All Subjects Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).


Arm/Group Title		All NEMI
Arm/Group Description:		Participants were administered with...
Arm/Group Description:		Participants were administered with either NEMI 1000 mcg using DISKUS DPI or NEMI 700 or 500 mcg using ELLIPTA DPI once daily in the morning. NEMI DISKUS and NEMI ELLIPTA were combined as All NEMI treatment group as there was no intent to compare two dose levels or devices.
Overall Number of Participants Analyzed		5
Mean (Standard Deviation) Unit of Measure: 10^12 cells per liter
Day 14, n= 5	Number Analyzed	5 participants
Day 14, n= 5		0.304 (0.1417)
Day 28, n= 4	Number Analyzed	4 participants
Day 28, n= 4		0.280 (0.0673)
Day 56, n= 4	Number Analyzed	4 participants
Day 56, n= 4		0.488 (0.1640)
Day 83, n= 4	Number Analyzed	4 participants
Day 83, n= 4		0.485 (0.1034)

19.Primary Outcome


Title	Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Description	FEV1 is used to assess pulmonary function using a spirometer at indica...
Description	FEV1 is used to assess pulmonary function using a spirometer at indicated timepoints. Baseline value is defined as the maximum measurement of the planned pre-dose measurements on Day 1, predose. Change from Baseline is defined as post-dose visit value minus Baseline value. Spirometry assessments were performed in accordance with American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines
Time Frame	Baseline (Day 1: pre-dose) and at Day 1: 1 Hour post-dose; Day 2: 1 Hour post-dose; Day 14: Pre-dose; Day 14: 1 Hour post-dose and Day 83: Pre-dose

Outcome Measure Data

Analysis Population Description

All Subjects Population.


Arm/Group Title		All NEMI
Arm/Group Description:		Participants were administered with...
Arm/Group Description:		Participants were administered with either NEMI 1000 mcg using DISKUS DPI or NEMI 700 or 500 mcg using ELLIPTA DPI once daily in the morning. NEMI DISKUS and NEMI ELLIPTA were combined as All NEMI treatment group as there was no intent to compare two dose levels or devices.
Overall Number of Participants Analyzed		5
Mean (Standard Deviation) Unit of Measure: Liters
Day 1, 1 Hour post-dose	Number Analyzed	4 participants
Day 1, 1 Hour post-dose		0.226 (0.2166)
Day 2, 1 Hour post-dose	Number Analyzed	4 participants
Day 2, 1 Hour post-dose		0.290 (0.2884)
Day 14, Pre-dose	Number Analyzed	4 participants
Day 14, Pre-dose		-0.165 (0.5024)
Day 14, 1 Hour post-dose	Number Analyzed	5 participants
Day 14, 1 Hour post-dose		0.016 (0.4812)
Day 83, Pre-dose	Number Analyzed	5 participants
Day 83, Pre-dose		-0.002 (0.4584)

20.Secondary Outcome


Title	Plasma Concentration Following Administration of NEMI
Description	Blood samples for pharmacokinetic analysis was collected at the indica...
Description	Blood samples for pharmacokinetic analysis was collected at the indicated time points following administration of NEMI. NA indicates that standard deviation could not be calculated as a single participant was analyzed
Time Frame	Day 1: Pre-dose, 5 minutes, 3 hours and 24 hours post-dose; Days 14 and 83: pre-dose

Outcome Measure Data

Analysis Population Description

Pharmacokinetic (PK) Population consisted of all participants in the 'All Subjects' population who had at least 1 non-missing PK assessment. 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	NEMI 500 mcg Via ELLIPTA
Arm/Group Description:		Participants were administered NEMI...	Participants were administered NEMI...	Participants were administered NEMI...
Arm/Group Description:		Participants were administered NEMI 1000 mcg using DISKUS DPI once daily in the morning.	Participants were administered NEMI 700 mcg using ELLIPTA DPI once daily in the morning.	Participants were administered NEMI 500 mcg using ELLIPTA DPI once daily in the morning.
Overall Number of Participants Analyzed		1	1	3
Mean (Standard Deviation) Unit of Measure: Picograms per milliliter
Day 1: Pre-dose; n=1,1,3	Number Analyzed	1 participants	1 participants	3 participants
Day 1: Pre-dose; n=1,1,3		0.00 ^[1] (NA)	0.00 ^[1] (NA)	0.00 (0.00)
Day 1: 5 minutes post-dose; n=1,1,3	Number Analyzed	1 participants	1 participants	3 participants
Day 1: 5 minutes post-dose; n=1,1,3		467.00 ^[1] (NA)	1524.70 ^[1] (NA)	658.27 (394.468)
Day 1: 3 hours post-dose; n=1,1,3	Number Analyzed	1 participants	1 participants	3 participants
Day 1: 3 hours post-dose; n=1,1,3		895.10 ^[1] (NA)	568.60 ^[1] (NA)	397.07 (172.226)
Day 1: 24 hours post-dose; n=1,1,3	Number Analyzed	1 participants	1 participants	3 participants
Day 1: 24 hours post-dose; n=1,1,3		444.40 ^[1] (NA)	304.90 ^[1] (NA)	198.17 (82.442)
Day 14: Pre-dose; n=1,1,3	Number Analyzed	1 participants	1 participants	3 participants
Day 14: Pre-dose; n=1,1,3		1396.70 ^[1] (NA)	1242.60 ^[1] (NA)	750.83 (526.337)
Day 83: Pre-dose; n=0,1,3	Number Analyzed	0 participants	1 participants	3 participants
Day 83: Pre-dose; n=0,1,3			1419.60 ^[1] (NA)	1525.83 (1181.340)

[1]

NA indicates that standard deviation could not be calculated as a single participant was analyzed

Adverse Events

Time Frame	Non-serious and serious adverse events were collected up to 7.5 months
Adverse Event Reporting Description	Non-serious and serious adverse events were collected in the All Subjects population. NEMI DISKUS and NEMI ELLIPTA were combined as All NEMI treatment group as there was no intent to compare two dose levels or devices.

Arm/Group Title	All NEMI
Arm/Group Description	Participants were administered with...
Arm/Group Description	Participants were administered with either NEMI 1000 mcg using DISKUS DPI or NEMI 700 or 500 mcg using ELLIPTA DPI once daily in the morning. NEMI DISKUS and NEMI ELLIPTA were combined as All NEMI treatment group as there was no intent to compare two dose levels or devices.
All-Cause Mortality
	All NEMI
	Affected / at Risk (%)
Total	0/5 (0.00%)
Serious Adverse Events Serious Adverse Events
	All NEMI
	Affected / at Risk (%)	# Events
Total	0/5 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	All NEMI
	Affected / at Risk (%)	# Events
Total	5/5 (100.00%)
Gastrointestinal disorders
Vomiting ^† 1	2/5 (40.00%)	4
Abdominal discomfort ^† 1	1/5 (20.00%)	3
Abdominal pain ^† 1	1/5 (20.00%)	1
Abdominal tenderness ^† 1	1/5 (20.00%)	1
Constipation ^† 1	1/5 (20.00%)	1
Diarrhoea ^† 1	1/5 (20.00%)	1
Mouth ulceration ^† 1	1/5 (20.00%)	1
General disorders
Chest discomfort ^† 1	1/5 (20.00%)	1
Fatigue ^† 1	1/5 (20.00%)	1
Feeling hot ^† 1	1/5 (20.00%)	1
Feeling of body temperature change ^† 1	1/5 (20.00%)	1
Pain ^† 1	1/5 (20.00%)	1
Swelling face ^† 1	1/5 (20.00%)	1
Immune system disorders
Seasonal allergy ^† 1	2/5 (40.00%)	2
Infections and infestations
Nasopharyngitis ^† 1	3/5 (60.00%)	7
Oral candidiasis ^† 1	1/5 (20.00%)	2
Sinusitis ^† 1	1/5 (20.00%)	1
Fungal skin infection ^† 1	1/5 (20.00%)	1
Skin bacterial infection ^† 1	1/5 (20.00%)	1
Injury, poisoning and procedural complications
Contusion ^† 1	1/5 (20.00%)	1
Skin abrasion ^† 1	1/5 (20.00%)	1
Metabolism and nutrition disorders
Iron deficiency ^† 1	1/5 (20.00%)	1
Vitamin B complex deficiency ^† 1	1/5 (20.00%)	1
Vitamin D deficiency ^† 1	1/5 (20.00%)	1
Musculoskeletal and connective tissue disorders
Back pain ^† 1	1/5 (20.00%)	1
Myalgia ^† 1	1/5 (20.00%)	1
Nervous system disorders
Headache ^† 1	3/5 (60.00%)	22
Migraine ^† 1	1/5 (20.00%)	1
Product Issues
Product taste abnormal ^† 1	1/5 (20.00%)	1
Respiratory, thoracic and mediastinal disorders
Bronchospasm ^† 1	1/5 (20.00%)	1
Cough ^† 1	3/5 (60.00%)	4
Epistaxis ^† 1	1/5 (20.00%)	1
Nasal congestion ^† 1	1/5 (20.00%)	1
Oropharyngeal pain ^† 1	1/5 (20.00%)	1
Pleuritic pain ^† 1	1/5 (20.00%)	1
Rhinorrhoea ^† 1	1/5 (20.00%)	2
Wheezing ^† 1	1/5 (20.00%)	2
Skin and subcutaneous tissue disorders
Rash ^† 1	1/5 (20.00%)	2
1 Term from vocabulary, MedDRA 20.0 † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

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

Layout table for Results Point of Contact information

Name/Title:	GSK Reponse Center
Organization:	GlaxoSmithKline
Phone:	866-435-7343
EMail:	GSKClinicalSupportHD@gsk.com

Layout table for additonal information

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT02593539
Other Study ID Numbers:	204745 2015-004876-31 ( EudraCT Number )
First Submitted:	October 29, 2015
First Posted:	November 1, 2015
Results First Submitted:	May 26, 2021
Results First Posted:	June 18, 2021
Last Update Posted:	June 18, 2021

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