Trial Outcomes & Findings for Safety, Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of Repeat Doses of Inhaled Nemiralisib in Patients With APDS/PASLI (NCT NCT02593539)
NCT ID: NCT02593539
Last Updated: 2021-06-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
Upto 7.5 months
Results posted on
2021-06-18
Participant Flow
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)
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.
Participant milestones
| Measure |
All NEMI
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 Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
All NEMI
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 Study
Adverse Event
|
1
|
Baseline Characteristics
Safety, Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of Repeat Doses of Inhaled Nemiralisib in Patients With APDS/PASLI
Baseline characteristics by cohort
| Measure |
All NEMI
n=5 Participants
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.
|
|---|---|
|
Age, Continuous
|
36.6 Years
STANDARD_DEVIATION 12.36 • n=99 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White-White/Caucasian/European Heritage
|
5 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Upto 7.5 monthsPopulation: All Subjects Population consisted of all participants who received at least one dose of the study treatment.
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.
Outcome measures
| Measure |
All NEMI
n=5 Participants
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.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered NEMI 700 mcg using ELLIPTA DPI once daily in the morning.
|
NEMI 500 mcg Via ELLIPTA
Participants were administered NEMI 500 mcg using ELLIPTA DPI once daily in the morning.
|
|---|---|---|---|
|
Number of Participants With Any Serious Adverse Events (SAEs) and Any Non-serious Adverse Events (Non-SAEs)
Any non-SAE
|
5 Participants
|
—
|
—
|
|
Number of Participants With Any Serious Adverse Events (SAEs) and Any Non-serious Adverse Events (Non-SAEs)
Any SAE
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose) and at Days 14, 28, 56, 83 and 84Population: All Subjects Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
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.
Outcome measures
| Measure |
All NEMI
n=5 Participants
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.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered NEMI 700 mcg using ELLIPTA DPI once daily in the morning.
|
NEMI 500 mcg Via ELLIPTA
Participants were administered NEMI 500 mcg using ELLIPTA DPI once daily in the morning.
|
|---|---|---|---|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Day 14, n= 5
|
1.0 Millimeters of Mercury (mmHg)
Standard Deviation 6.44
|
—
|
—
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Day 28, n= 4
|
4.0 Millimeters of Mercury (mmHg)
Standard Deviation 6.98
|
—
|
—
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Day 56, n= 4
|
8.5 Millimeters of Mercury (mmHg)
Standard Deviation 5.80
|
—
|
—
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Day 83, n= 4
|
2.0 Millimeters of Mercury (mmHg)
Standard Deviation 4.40
|
—
|
—
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Day 28, n= 4
|
5.3 Millimeters of Mercury (mmHg)
Standard Deviation 8.54
|
—
|
—
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Day 56, n= 4
|
10.0 Millimeters of Mercury (mmHg)
Standard Deviation 9.31
|
—
|
—
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Day 83, n= 4
|
1.5 Millimeters of Mercury (mmHg)
Standard Deviation 3.51
|
—
|
—
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Day 84, n= 1
|
16.0 Millimeters of Mercury (mmHg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated as a single participant was analyzed.
|
—
|
—
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Day 84 n= 1
|
17.0 Millimeters of Mercury (mmHg)
Standard Deviation NA
NA indicates that standard deviation could not be calculated as a single participant was analyzed.
|
—
|
—
|
|
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Day 14, n= 5
|
-1.0 Millimeters of Mercury (mmHg)
Standard Deviation 3.67
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose) and at Days 14, 28, 56, 83 and 84Population: All Subjects Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
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.
Outcome measures
| Measure |
All NEMI
n=5 Participants
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.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered NEMI 700 mcg using ELLIPTA DPI once daily in the morning.
|
NEMI 500 mcg Via ELLIPTA
Participants were administered NEMI 500 mcg using ELLIPTA DPI once daily in the morning.
|
|---|---|---|---|
|
Change From Baseline in Pulse Rate
Day 14, n= 5
|
3.2 Beats per minute
Standard Deviation 7.73
|
—
|
—
|
|
Change From Baseline in Pulse Rate
Day 28, n= 4
|
2.0 Beats per minute
Standard Deviation 10.86
|
—
|
—
|
|
Change From Baseline in Pulse Rate
Day 56, n= 4
|
6.8 Beats per minute
Standard Deviation 9.43
|
—
|
—
|
|
Change From Baseline in Pulse Rate
Day 83, n= 4
|
4.8 Beats per minute
Standard Deviation 7.76
|
—
|
—
|
|
Change From Baseline in Pulse Rate
Day 84 n= 1
|
7.0 Beats per minute
Standard Deviation NA
NA indicates that standard deviation could not be calculated as a single participant was analyzed.
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose) and at Days 14, 28, 56, 83 and 84Population: All Subjects Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
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.
Outcome measures
| Measure |
All NEMI
n=5 Participants
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.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered NEMI 700 mcg using ELLIPTA DPI once daily in the morning.
|
NEMI 500 mcg Via ELLIPTA
Participants were administered NEMI 500 mcg using ELLIPTA DPI once daily in the morning.
|
|---|---|---|---|
|
Change From Baseline in Respiratory Rate
Day 14, n= 5
|
0.2 Breaths per minute
Standard Deviation 2.28
|
—
|
—
|
|
Change From Baseline in Respiratory Rate
Day 28, n= 4
|
0.8 Breaths per minute
Standard Deviation 4.57
|
—
|
—
|
|
Change From Baseline in Respiratory Rate
Day 56, n= 4
|
1.5 Breaths per minute
Standard Deviation 5.26
|
—
|
—
|
|
Change From Baseline in Respiratory Rate
Day 83, n= 4
|
1.0 Breaths per minute
Standard Deviation 2.45
|
—
|
—
|
|
Change From Baseline in Respiratory Rate
Day 84 n= 1
|
2.0 Breaths per minute
Standard Deviation NA
NA indicates that standard deviation could not be calculated as a single participant was analyzed.
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose) and at Days 14, 28, 56, 83 and 84Population: All Subjects Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
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.
Outcome measures
| Measure |
All NEMI
n=5 Participants
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.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered NEMI 700 mcg using ELLIPTA DPI once daily in the morning.
|
NEMI 500 mcg Via ELLIPTA
Participants were administered NEMI 500 mcg using ELLIPTA DPI once daily in the morning.
|
|---|---|---|---|
|
Change From Baseline in Body Temperature
Day 14, n= 5
|
0.10 Degrees celsius
Standard Deviation 0.158
|
—
|
—
|
|
Change From Baseline in Body Temperature
Day 28, n= 4
|
0.17 Degrees celsius
Standard Deviation 0.350
|
—
|
—
|
|
Change From Baseline in Body Temperature
Day 56, n= 4
|
0.07 Degrees celsius
Standard Deviation 0.171
|
—
|
—
|
|
Change From Baseline in Body Temperature
Day 83, n= 4
|
0.17 Degrees celsius
Standard Deviation 0.479
|
—
|
—
|
|
Change From Baseline in Body Temperature
Day 84 n= 1
|
0.50 Degrees celsius
Standard Deviation NA
NA indicates that standard deviation could not be calculated as a single participant was analyzed.
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose) and at Days 14, 28, 56 and 83Population: All Subjects Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
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.
Outcome measures
| Measure |
All NEMI
n=5 Participants
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.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered NEMI 700 mcg using ELLIPTA DPI once daily in the morning.
|
NEMI 500 mcg Via ELLIPTA
Participants were administered NEMI 500 mcg using ELLIPTA DPI once daily in the morning.
|
|---|---|---|---|
|
Change From Baseline in Electrocardiogram (ECG) Mean Heart Rate
Day 14, n= 5
|
-1.0 Beats per minute
Standard Deviation 3.94
|
—
|
—
|
|
Change From Baseline in Electrocardiogram (ECG) Mean Heart Rate
Day 28, n= 4
|
-0.8 Beats per minute
Standard Deviation 2.99
|
—
|
—
|
|
Change From Baseline in Electrocardiogram (ECG) Mean Heart Rate
Day 56, n= 4
|
5.3 Beats per minute
Standard Deviation 7.54
|
—
|
—
|
|
Change From Baseline in Electrocardiogram (ECG) Mean Heart Rate
Day 83, n= 4
|
1.0 Beats per minute
Standard Deviation 2.31
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose) and at Days 14, 28, 56 and 83Population: All Subjects Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
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.
Outcome measures
| Measure |
All NEMI
n=5 Participants
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.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered NEMI 700 mcg using ELLIPTA DPI once daily in the morning.
|
NEMI 500 mcg Via ELLIPTA
Participants were administered NEMI 500 mcg using ELLIPTA DPI once daily in the morning.
|
|---|---|---|---|
|
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)
PR, Day 28, n= 4
|
-4.8 Milliseconds
Standard Deviation 4.27
|
—
|
—
|
|
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)
QTcF, Day 28, n= 4
|
-3.5 Milliseconds
Standard Deviation 24.09
|
—
|
—
|
|
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)
QTcF, Day 56, n= 4
|
-13.0 Milliseconds
Standard Deviation 19.92
|
—
|
—
|
|
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)
PR, Day 14, n= 5
|
-2.2 Milliseconds
Standard Deviation 9.23
|
—
|
—
|
|
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)
PR, Day 56, n= 4
|
-3.3 Milliseconds
Standard Deviation 11.18
|
—
|
—
|
|
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)
PR, Day 83, n= 4
|
-6.0 Milliseconds
Standard Deviation 11.80
|
—
|
—
|
|
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)
QRS Duration, Day 14, n= 5
|
-5.6 Milliseconds
Standard Deviation 7.33
|
—
|
—
|
|
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)
QRS Duration, Day 28, n= 4
|
-4.5 Milliseconds
Standard Deviation 11.03
|
—
|
—
|
|
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)
QRS Duration, Day 56, n= 4
|
-6.5 Milliseconds
Standard Deviation 8.81
|
—
|
—
|
|
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)
QRS Duration, Day 83, n= 4
|
-6.0 Milliseconds
Standard Deviation 7.79
|
—
|
—
|
|
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)
QT Interval, Day 14, n= 5
|
-7.2 Milliseconds
Standard Deviation 10.66
|
—
|
—
|
|
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)
QT Interval, Day 28, n= 4
|
-2.8 Milliseconds
Standard Deviation 28.89
|
—
|
—
|
|
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)
QT Interval, Day 56, n= 4
|
-22.3 Milliseconds
Standard Deviation 16.01
|
—
|
—
|
|
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)
QT Interval, Day 83, n= 4
|
-16.3 Milliseconds
Standard Deviation 9.74
|
—
|
—
|
|
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)
QTcB, Day 14, n= 5
|
-9.4 Milliseconds
Standard Deviation 4.93
|
—
|
—
|
|
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)
QTcB, Day 28, n= 4
|
-4.5 Milliseconds
Standard Deviation 22.55
|
—
|
—
|
|
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)
QTcB, Day 56, n= 4
|
-8.3 Milliseconds
Standard Deviation 24.55
|
—
|
—
|
|
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)
QTcB, Day 83, n= 4
|
-12.5 Milliseconds
Standard Deviation 8.19
|
—
|
—
|
|
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)
QTcF, Day 14, n= 5
|
-8.2 Milliseconds
Standard Deviation 4.32
|
—
|
—
|
|
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)
QTcF, Day 83, n= 4
|
-14.0 Milliseconds
Standard Deviation 7.79
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and at Days 14, 28, 56 and 83Population: All Subjects Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
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.
Outcome measures
| Measure |
All NEMI
n=5 Participants
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.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered NEMI 700 mcg using ELLIPTA DPI once daily in the morning.
|
NEMI 500 mcg Via ELLIPTA
Participants were administered NEMI 500 mcg using ELLIPTA DPI once daily in the morning.
|
|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT, Day 56, n= 4
|
0.0 International units per liter (IU/L)
Standard Deviation 1.63
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT, Day 83, n= 4
|
1.3 International units per liter (IU/L)
Standard Deviation 7.50
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST, Day 14, n= 5
|
-0.8 International units per liter (IU/L)
Standard Deviation 1.48
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST, Day 28, n= 4
|
0.8 International units per liter (IU/L)
Standard Deviation 2.22
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST, Day 56, n= 4
|
-0.8 International units per liter (IU/L)
Standard Deviation 4.79
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST, Day 83, n= 4
|
-1.0 International units per liter (IU/L)
Standard Deviation 7.70
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP, Day 14, n= 5
|
2.6 International units per liter (IU/L)
Standard Deviation 5.77
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP, Day 83, n= 4
|
6.0 International units per liter (IU/L)
Standard Deviation 2.94
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT, Day 14, n= 5
|
1.0 International units per liter (IU/L)
Standard Deviation 2.12
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT, Day 28, n= 4
|
0.8 International units per liter (IU/L)
Standard Deviation 1.71
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP, Day 28, n= 4
|
3.8 International units per liter (IU/L)
Standard Deviation 5.68
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP, Day 56, n= 4
|
7.5 International units per liter (IU/L)
Standard Deviation 5.00
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and at Days 14, 28, 56 and 83Population: All Subjects Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
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.
Outcome measures
| Measure |
All NEMI
n=5 Participants
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.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered NEMI 700 mcg using ELLIPTA DPI once daily in the morning.
|
NEMI 500 mcg Via ELLIPTA
Participants were administered NEMI 500 mcg using ELLIPTA DPI once daily in the morning.
|
|---|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein
Albumin, Day 14, n= 5
|
2.6 Grams per liter
Standard Deviation 2.07
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein
Albumin, Day 28, n= 4
|
1.3 Grams per liter
Standard Deviation 3.20
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein
Albumin, Day 56, n= 4
|
2.8 Grams per liter
Standard Deviation 2.36
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein
Total Protein, Day 28, n= 4
|
1.3 Grams per liter
Standard Deviation 3.59
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein
Total Protein, Day 56, n= 4
|
4.0 Grams per liter
Standard Deviation 4.76
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein
Albumin, Day 83, n= 4
|
2.0 Grams per liter
Standard Deviation 3.16
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein
Total Protein, Day 14, n= 5
|
4.0 Grams per liter
Standard Deviation 1.58
|
—
|
—
|
|
Change From Baseline in Clinical Chemistry Parameters : Albumin and Total Protein
Total Protein, Day 83, n= 4
|
4.3 Grams per liter
Standard Deviation 2.50
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and at Days 14, 28, 56 and 83Population: All Subjects Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
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.
Outcome measures
| Measure |
All NEMI
n=5 Participants
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.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered NEMI 700 mcg using ELLIPTA DPI once daily in the morning.
|
NEMI 500 mcg Via ELLIPTA
Participants were administered NEMI 500 mcg using ELLIPTA DPI once daily in the morning.
|
|---|---|---|---|
|
Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose and Urea
Potassium, Day 28, n= 4
|
0.30 Millimoles per liter
Standard Deviation 0.346
|
—
|
—
|
|
Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose and Urea
Potassium, Day 56, n= 4
|
0.35 Millimoles per liter
Standard Deviation 0.370
|
—
|
—
|
|
Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose and Urea
Potassium, Day 83, n= 4
|
0.38 Millimoles per liter
Standard Deviation 0.275
|
—
|
—
|
|
Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose and Urea
Calcium, Day 14, n= 5
|
0.040 Millimoles per liter
Standard Deviation 0.0990
|
—
|
—
|
|
Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose and Urea
Calcium, Day 28, n= 4
|
0.063 Millimoles per liter
Standard Deviation 0.0704
|
—
|
—
|
|
Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose and Urea
Calcium, Day 56, n= 4
|
0.133 Millimoles per liter
Standard Deviation 0.1343
|
—
|
—
|
|
Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose and Urea
Calcium, Day 83, n= 4
|
0.082 Millimoles per liter
Standard Deviation 0.1325
|
—
|
—
|
|
Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose and Urea
Urea, Day 56, n= 4
|
2.610 Millimoles per liter
Standard Deviation 5.1954
|
—
|
—
|
|
Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose and Urea
Urea, Day 83, n= 4
|
2.185 Millimoles per liter
Standard Deviation 4.1025
|
—
|
—
|
|
Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose and Urea
Sodium, Day 14, n= 5
|
-0.2 Millimoles per liter
Standard Deviation 2.68
|
—
|
—
|
|
Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose and Urea
Sodium, Day 28, n= 4
|
0.5 Millimoles per liter
Standard Deviation 0.58
|
—
|
—
|
|
Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose and Urea
Sodium, Day 56, n= 4
|
-0.8 Millimoles per liter
Standard Deviation 2.06
|
—
|
—
|
|
Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose and Urea
Sodium, Day 83, n= 4
|
0.0 Millimoles per liter
Standard Deviation 1.83
|
—
|
—
|
|
Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose and Urea
Potassium, Day 14, n= 5
|
0.24 Millimoles per liter
Standard Deviation 0.397
|
—
|
—
|
|
Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose and Urea
Glucose, Day 14, n= 5
|
-0.64 Millimoles per liter
Standard Deviation 1.557
|
—
|
—
|
|
Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose and Urea
Glucose, Day 28, n= 4
|
-0.60 Millimoles per liter
Standard Deviation 1.774
|
—
|
—
|
|
Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose and Urea
Glucose, Day 56, n= 4
|
-0.48 Millimoles per liter
Standard Deviation 1.578
|
—
|
—
|
|
Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose and Urea
Glucose, Day 83, n= 4
|
-0.68 Millimoles per liter
Standard Deviation 1.333
|
—
|
—
|
|
Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose and Urea
Urea, Day 14, n= 5
|
4.732 Millimoles per liter
Standard Deviation 5.8283
|
—
|
—
|
|
Change From Baseline Values in Clinical Chemistry Parameters: Sodium, Potassium, Calcium, Glucose and Urea
Urea, Day 28, n= 4
|
8.330 Millimoles per liter
Standard Deviation 2.6837
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and at Days 14, 28, 56 and 83Population: All Subjects Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
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.
Outcome measures
| Measure |
All NEMI
n=5 Participants
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.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered NEMI 700 mcg using ELLIPTA DPI once daily in the morning.
|
NEMI 500 mcg Via ELLIPTA
Participants were administered NEMI 500 mcg using ELLIPTA DPI once daily in the morning.
|
|---|---|---|---|
|
Change From Baseline Values in Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine
Direct bilirubin, Day 56, n= 4
|
-0.5 Micromoles per liter
Standard Deviation 1.00
|
—
|
—
|
|
Change From Baseline Values in Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine
Creatinine , Day 56, n= 4
|
5.0 Micromoles per liter
Standard Deviation 14.07
|
—
|
—
|
|
Change From Baseline Values in Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine
Creatinine , Day 83, n= 4
|
-2.5 Micromoles per liter
Standard Deviation 14.93
|
—
|
—
|
|
Change From Baseline Values in Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine
Direct bilirubin, Day 14, n= 5
|
-1.0 Micromoles per liter
Standard Deviation 0.71
|
—
|
—
|
|
Change From Baseline Values in Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine
Direct bilirubin, Day 28, n= 4
|
-1.8 Micromoles per liter
Standard Deviation 0.96
|
—
|
—
|
|
Change From Baseline Values in Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine
Direct bilirubin, Day 83, n= 4
|
-0.5 Micromoles per liter
Standard Deviation 1.00
|
—
|
—
|
|
Change From Baseline Values in Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine
Total bilirubin, Day 14, n= 5
|
-1.8 Micromoles per liter
Standard Deviation 1.64
|
—
|
—
|
|
Change From Baseline Values in Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine
Total bilirubin, Day 28, n= 4
|
-3.0 Micromoles per liter
Standard Deviation 2.45
|
—
|
—
|
|
Change From Baseline Values in Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine
Total bilirubin, Day 56, n= 4
|
-0.8 Micromoles per liter
Standard Deviation 1.89
|
—
|
—
|
|
Change From Baseline Values in Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine
Total bilirubin, Day 83, n= 4
|
-1.5 Micromoles per liter
Standard Deviation 2.52
|
—
|
—
|
|
Change From Baseline Values in Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine
Creatinine , Day 14, n= 5
|
-2.0 Micromoles per liter
Standard Deviation 12.43
|
—
|
—
|
|
Change From Baseline Values in Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine
Creatinine , Day 28, n= 4
|
-4.3 Micromoles per liter
Standard Deviation 6.08
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose) and at Days 14, 28, 56 and 83Population: All Subjects Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
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.
Outcome measures
| Measure |
All NEMI
n=5 Participants
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.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered NEMI 700 mcg using ELLIPTA DPI once daily in the morning.
|
NEMI 500 mcg Via ELLIPTA
Participants were administered NEMI 500 mcg using ELLIPTA DPI once daily in the morning.
|
|---|---|---|---|
|
Change From Baseline Values in Clinical Chemistry Parameter: C-Reactive Protein
Day 14, n= 5
|
0.56 Milligrams per liter
Standard Deviation 1.592
|
—
|
—
|
|
Change From Baseline Values in Clinical Chemistry Parameter: C-Reactive Protein
Day 28, n= 4
|
0.75 Milligrams per liter
Standard Deviation 1.085
|
—
|
—
|
|
Change From Baseline Values in Clinical Chemistry Parameter: C-Reactive Protein
Day 56, n= 4
|
2.75 Milligrams per liter
Standard Deviation 6.222
|
—
|
—
|
|
Change From Baseline Values in Clinical Chemistry Parameter: C-Reactive Protein
Day 83, n= 4
|
3.90 Milligrams per liter
Standard Deviation 7.141
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and at Days 14, 28, 56 and 83Population: All Subjects Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
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.
Outcome measures
| Measure |
All NEMI
n=5 Participants
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.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered NEMI 700 mcg using ELLIPTA DPI once daily in the morning.
|
NEMI 500 mcg Via ELLIPTA
Participants were administered NEMI 500 mcg using ELLIPTA DPI once daily in the morning.
|
|---|---|---|---|
|
Change From Baseline for Hematology Parameters: Basophil, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes and Platelets
Lymphocytes, Day 28, n= 4
|
-0.133 10^9 cells per liters
Standard Deviation 0.0918
|
—
|
—
|
|
Change From Baseline for Hematology Parameters: Basophil, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes and Platelets
Lymphocytes, Day 56, n= 4
|
-0.105 10^9 cells per liters
Standard Deviation 0.1115
|
—
|
—
|
|
Change From Baseline for Hematology Parameters: Basophil, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes and Platelets
Lymphocytes, Day 83, n= 4
|
0.037 10^9 cells per liters
Standard Deviation 0.3140
|
—
|
—
|
|
Change From Baseline for Hematology Parameters: Basophil, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes and Platelets
Basophils, Day 28, n= 4
|
0.008 10^9 cells per liters
Standard Deviation 0.0096
|
—
|
—
|
|
Change From Baseline for Hematology Parameters: Basophil, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes and Platelets
Eosinophils, Day 56, n= 4
|
0.128 10^9 cells per liters
Standard Deviation 0.2241
|
—
|
—
|
|
Change From Baseline for Hematology Parameters: Basophil, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes and Platelets
Eosinophils, Day 83, n= 4
|
0.075 10^9 cells per liters
Standard Deviation 0.0810
|
—
|
—
|
|
Change From Baseline for Hematology Parameters: Basophil, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes and Platelets
Lymphocytes, Day 14, n= 5
|
0.122 10^9 cells per liters
Standard Deviation 0.2411
|
—
|
—
|
|
Change From Baseline for Hematology Parameters: Basophil, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes and Platelets
Neutrophils , Day 14, n= 5
|
0.334 10^9 cells per liters
Standard Deviation 1.2388
|
—
|
—
|
|
Change From Baseline for Hematology Parameters: Basophil, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes and Platelets
Neutrophils , Day 28, n= 4
|
0.575 10^9 cells per liters
Standard Deviation 0.6125
|
—
|
—
|
|
Change From Baseline for Hematology Parameters: Basophil, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes and Platelets
Neutrophils , Day 56, n= 4
|
0.553 10^9 cells per liters
Standard Deviation 0.7647
|
—
|
—
|
|
Change From Baseline for Hematology Parameters: Basophil, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes and Platelets
Platelet, Day 14, n= 5
|
49.4 10^9 cells per liters
Standard Deviation 52.53
|
—
|
—
|
|
Change From Baseline for Hematology Parameters: Basophil, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes and Platelets
Platelet, Day 28, n= 4
|
9.0 10^9 cells per liters
Standard Deviation 25.86
|
—
|
—
|
|
Change From Baseline for Hematology Parameters: Basophil, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes and Platelets
Platelet, Day 56, n= 4
|
17.0 10^9 cells per liters
Standard Deviation 31.79
|
—
|
—
|
|
Change From Baseline for Hematology Parameters: Basophil, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes and Platelets
Platelet, Day 83, n= 4
|
61.8 10^9 cells per liters
Standard Deviation 43.41
|
—
|
—
|
|
Change From Baseline for Hematology Parameters: Basophil, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes and Platelets
WBC, Day 14, n= 5
|
0.656 10^9 cells per liters
Standard Deviation 1.0304
|
—
|
—
|
|
Change From Baseline for Hematology Parameters: Basophil, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes and Platelets
WBC, Day 28, n= 4
|
0.568 10^9 cells per liters
Standard Deviation 0.6004
|
—
|
—
|
|
Change From Baseline for Hematology Parameters: Basophil, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes and Platelets
Basophils, Day 14, n= 5
|
-0.002 10^9 cells per liters
Standard Deviation 0.0045
|
—
|
—
|
|
Change From Baseline for Hematology Parameters: Basophil, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes and Platelets
Basophils, Day 56, n= 4
|
0.008 10^9 cells per liters
Standard Deviation 0.0236
|
—
|
—
|
|
Change From Baseline for Hematology Parameters: Basophil, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes and Platelets
Basophils, Day 83, n= 4
|
0.013 10^9 cells per liters
Standard Deviation 0.0222
|
—
|
—
|
|
Change From Baseline for Hematology Parameters: Basophil, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes and Platelets
Eosinophils, Day 14, n= 5
|
0.108 10^9 cells per liters
Standard Deviation 0.1542
|
—
|
—
|
|
Change From Baseline for Hematology Parameters: Basophil, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes and Platelets
Eosinophils, Day 28, n= 4
|
0.088 10^9 cells per liters
Standard Deviation 0.0650
|
—
|
—
|
|
Change From Baseline for Hematology Parameters: Basophil, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes and Platelets
Monocytes, Day 14, n= 5
|
0.096 10^9 cells per liters
Standard Deviation 0.2893
|
—
|
—
|
|
Change From Baseline for Hematology Parameters: Basophil, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes and Platelets
Monocytes, Day 28, n= 4
|
0.030 10^9 cells per liters
Standard Deviation 0.0572
|
—
|
—
|
|
Change From Baseline for Hematology Parameters: Basophil, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes and Platelets
Monocytes, Day 56, n= 4
|
0.115 10^9 cells per liters
Standard Deviation 0.0614
|
—
|
—
|
|
Change From Baseline for Hematology Parameters: Basophil, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes and Platelets
Monocytes, Day 83, n= 4
|
0.065 10^9 cells per liters
Standard Deviation 0.0592
|
—
|
—
|
|
Change From Baseline for Hematology Parameters: Basophil, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes and Platelets
Neutrophils , Day 83, n= 4
|
0.653 10^9 cells per liters
Standard Deviation 0.7857
|
—
|
—
|
|
Change From Baseline for Hematology Parameters: Basophil, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes and Platelets
WBC, Day 56, n= 4
|
0.698 10^9 cells per liters
Standard Deviation 1.0605
|
—
|
—
|
|
Change From Baseline for Hematology Parameters: Basophil, Eosinophils, White Blood Cells (WBC), Lymphocytes, Neutrophils, Monocytes and Platelets
WBC, Day 83, n= 4
|
0.845 10^9 cells per liters
Standard Deviation 0.6608
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose) and at Days 14, 28, 56 and 83Population: All Subjects Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
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.
Outcome measures
| Measure |
All NEMI
n=5 Participants
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.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered NEMI 700 mcg using ELLIPTA DPI once daily in the morning.
|
NEMI 500 mcg Via ELLIPTA
Participants were administered NEMI 500 mcg using ELLIPTA DPI once daily in the morning.
|
|---|---|---|---|
|
Change From Baseline for Hematology Parameter: Hemoglobin
Day 14, n= 5
|
10.0 Grams per liter
Standard Deviation 5.24
|
—
|
—
|
|
Change From Baseline for Hematology Parameter: Hemoglobin
Day 28, n= 4
|
8.3 Grams per liter
Standard Deviation 3.77
|
—
|
—
|
|
Change From Baseline for Hematology Parameter: Hemoglobin
Day 56, n= 4
|
13.5 Grams per liter
Standard Deviation 8.50
|
—
|
—
|
|
Change From Baseline for Hematology Parameter: Hemoglobin
Day 83, n= 4
|
13.3 Grams per liter
Standard Deviation 5.74
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose) and at Days 14, 28, 56 and 83Population: All Subjects Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
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.
Outcome measures
| Measure |
All NEMI
n=5 Participants
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.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered NEMI 700 mcg using ELLIPTA DPI once daily in the morning.
|
NEMI 500 mcg Via ELLIPTA
Participants were administered NEMI 500 mcg using ELLIPTA DPI once daily in the morning.
|
|---|---|---|---|
|
Change From Baseline for Hematology Parameter: Hematocrit
Day 14, n= 5
|
0.0320 Percentage of red blood cells in blood
Standard Deviation 0.01488
|
—
|
—
|
|
Change From Baseline for Hematology Parameter: Hematocrit
Day 28, n= 4
|
0.0333 Percentage of red blood cells in blood
Standard Deviation 0.01204
|
—
|
—
|
|
Change From Baseline for Hematology Parameter: Hematocrit
Day 56, n= 4
|
0.0518 Percentage of red blood cells in blood
Standard Deviation 0.02337
|
—
|
—
|
|
Change From Baseline for Hematology Parameter: Hematocrit
Day 83, n= 4
|
0.0465 Percentage of red blood cells in blood
Standard Deviation 0.01396
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose) and at Days 14, 28, 56 and 83Population: All Subjects Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
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.
Outcome measures
| Measure |
All NEMI
n=5 Participants
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.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered NEMI 700 mcg using ELLIPTA DPI once daily in the morning.
|
NEMI 500 mcg Via ELLIPTA
Participants were administered NEMI 500 mcg using ELLIPTA DPI once daily in the morning.
|
|---|---|---|---|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV)
Day 14, n= 5
|
1.00 Femtoliters
Standard Deviation 2.187
|
—
|
—
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV)
Day 28, n= 4
|
2.33 Femtoliters
Standard Deviation 2.287
|
—
|
—
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV)
Day 56, n= 4
|
2.02 Femtoliters
Standard Deviation 2.331
|
—
|
—
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV)
Day 83, n= 4
|
1.03 Femtoliters
Standard Deviation 3.407
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose) and at Days 14, 28, 56 and 83Population: All Subjects Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
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.
Outcome measures
| Measure |
All NEMI
n=5 Participants
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.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered NEMI 700 mcg using ELLIPTA DPI once daily in the morning.
|
NEMI 500 mcg Via ELLIPTA
Participants were administered NEMI 500 mcg using ELLIPTA DPI once daily in the morning.
|
|---|---|---|---|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
Day 56, n= 4
|
-0.43 Picograms
Standard Deviation 0.763
|
—
|
—
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
Day 83, n= 4
|
-0.47 Picograms
Standard Deviation 0.525
|
—
|
—
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
Day 14, n= 5
|
0.10 Picograms
Standard Deviation 0.485
|
—
|
—
|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
Day 28, n= 4
|
-0.15 Picograms
Standard Deviation 0.676
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose) and at Days 14, 28, 56 and 83Population: All Subjects Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
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.
Outcome measures
| Measure |
All NEMI
n=5 Participants
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.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered NEMI 700 mcg using ELLIPTA DPI once daily in the morning.
|
NEMI 500 mcg Via ELLIPTA
Participants were administered NEMI 500 mcg using ELLIPTA DPI once daily in the morning.
|
|---|---|---|---|
|
Change From Baseline for Hematology Parameter: Red Blood Cell Count
Day 14, n= 5
|
0.304 10^12 cells per liter
Standard Deviation 0.1417
|
—
|
—
|
|
Change From Baseline for Hematology Parameter: Red Blood Cell Count
Day 28, n= 4
|
0.280 10^12 cells per liter
Standard Deviation 0.0673
|
—
|
—
|
|
Change From Baseline for Hematology Parameter: Red Blood Cell Count
Day 56, n= 4
|
0.488 10^12 cells per liter
Standard Deviation 0.1640
|
—
|
—
|
|
Change From Baseline for Hematology Parameter: Red Blood Cell Count
Day 83, n= 4
|
0.485 10^12 cells per liter
Standard Deviation 0.1034
|
—
|
—
|
PRIMARY outcome
Timeframe: 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-dosePopulation: All Subjects Population.
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
Outcome measures
| Measure |
All NEMI
n=5 Participants
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.
|
NEMI 700 mcg Via ELLIPTA
Participants were administered NEMI 700 mcg using ELLIPTA DPI once daily in the morning.
|
NEMI 500 mcg Via ELLIPTA
Participants were administered NEMI 500 mcg using ELLIPTA DPI once daily in the morning.
|
|---|---|---|---|
|
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Day 14, 1 Hour post-dose
|
0.016 Liters
Standard Deviation 0.4812
|
—
|
—
|
|
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Day 1, 1 Hour post-dose
|
0.226 Liters
Standard Deviation 0.2166
|
—
|
—
|
|
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Day 2, 1 Hour post-dose
|
0.290 Liters
Standard Deviation 0.2884
|
—
|
—
|
|
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Day 14, Pre-dose
|
-0.165 Liters
Standard Deviation 0.5024
|
—
|
—
|
|
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Day 83, Pre-dose
|
-0.002 Liters
Standard Deviation 0.4584
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose, 5 minutes, 3 hours and 24 hours post-dose; Days 14 and 83: pre-dosePopulation: 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).
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
Outcome measures
| Measure |
All NEMI
n=1 Participants
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.
|
NEMI 700 mcg Via ELLIPTA
n=1 Participants
Participants were administered NEMI 700 mcg using ELLIPTA DPI once daily in the morning.
|
NEMI 500 mcg Via ELLIPTA
n=3 Participants
Participants were administered NEMI 500 mcg using ELLIPTA DPI once daily in the morning.
|
|---|---|---|---|
|
Plasma Concentration Following Administration of NEMI
Day 1: 3 hours post-dose; n=1,1,3
|
895.10 Picograms per milliliter
Standard Deviation NA
NA indicates that standard deviation could not be calculated as a single participant was analyzed
|
568.60 Picograms per milliliter
Standard Deviation NA
NA indicates that standard deviation could not be calculated as a single participant was analyzed
|
397.07 Picograms per milliliter
Standard Deviation 172.226
|
|
Plasma Concentration Following Administration of NEMI
Day 1: Pre-dose; n=1,1,3
|
0.00 Picograms per milliliter
Standard Deviation NA
NA indicates that standard deviation could not be calculated as a single participant was analyzed
|
0.00 Picograms per milliliter
Standard Deviation NA
NA indicates that standard deviation could not be calculated as a single participant was analyzed
|
0.00 Picograms per milliliter
Standard Deviation 0.00
|
|
Plasma Concentration Following Administration of NEMI
Day 1: 5 minutes post-dose; n=1,1,3
|
467.00 Picograms per milliliter
Standard Deviation NA
NA indicates that standard deviation could not be calculated as a single participant was analyzed
|
1524.70 Picograms per milliliter
Standard Deviation NA
NA indicates that standard deviation could not be calculated as a single participant was analyzed
|
658.27 Picograms per milliliter
Standard Deviation 394.468
|
|
Plasma Concentration Following Administration of NEMI
Day 1: 24 hours post-dose; n=1,1,3
|
444.40 Picograms per milliliter
Standard Deviation NA
NA indicates that standard deviation could not be calculated as a single participant was analyzed
|
304.90 Picograms per milliliter
Standard Deviation NA
NA indicates that standard deviation could not be calculated as a single participant was analyzed
|
198.17 Picograms per milliliter
Standard Deviation 82.442
|
|
Plasma Concentration Following Administration of NEMI
Day 14: Pre-dose; n=1,1,3
|
1396.70 Picograms per milliliter
Standard Deviation NA
NA indicates that standard deviation could not be calculated as a single participant was analyzed
|
1242.60 Picograms per milliliter
Standard Deviation NA
NA indicates that standard deviation could not be calculated as a single participant was analyzed
|
750.83 Picograms per milliliter
Standard Deviation 526.337
|
|
Plasma Concentration Following Administration of NEMI
Day 83: Pre-dose; n=0,1,3
|
—
|
1419.60 Picograms per milliliter
Standard Deviation NA
NA indicates that standard deviation could not be calculated as a single participant was analyzed
|
1525.83 Picograms per milliliter
Standard Deviation 1181.340
|
Adverse Events
All NEMI
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All NEMI
n=5 participants at risk
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.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
20.0%
1/5 • Number of events 1 • Non-serious and serious adverse events were collected up to 7.5 months
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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
60.0%
3/5 • Number of events 4 • Non-serious and serious adverse events were collected up to 7.5 months
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.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
20.0%
1/5 • Number of events 1 • Non-serious and serious adverse events were collected up to 7.5 months
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.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
20.0%
1/5 • Number of events 1 • Non-serious and serious adverse events were collected up to 7.5 months
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.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
20.0%
1/5 • Number of events 1 • Non-serious and serious adverse events were collected up to 7.5 months
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
20.0%
1/5 • Number of events 1 • Non-serious and serious adverse events were collected up to 7.5 months
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.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
20.0%
1/5 • Number of events 2 • Non-serious and serious adverse events were collected up to 7.5 months
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.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
20.0%
1/5 • Number of events 2 • Non-serious and serious adverse events were collected up to 7.5 months
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.
|
|
General disorders
Chest discomfort
|
20.0%
1/5 • Number of events 1 • Non-serious and serious adverse events were collected up to 7.5 months
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.
|
|
General disorders
Fatigue
|
20.0%
1/5 • Number of events 1 • Non-serious and serious adverse events were collected up to 7.5 months
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.
|
|
General disorders
Feeling hot
|
20.0%
1/5 • Number of events 1 • Non-serious and serious adverse events were collected up to 7.5 months
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.
|
|
General disorders
Feeling of body temperature change
|
20.0%
1/5 • Number of events 1 • Non-serious and serious adverse events were collected up to 7.5 months
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.
|
|
General disorders
Pain
|
20.0%
1/5 • Number of events 1 • Non-serious and serious adverse events were collected up to 7.5 months
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.
|
|
General disorders
Swelling face
|
20.0%
1/5 • Number of events 1 • Non-serious and serious adverse events were collected up to 7.5 months
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.
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
2/5 • Number of events 4 • Non-serious and serious adverse events were collected up to 7.5 months
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.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
20.0%
1/5 • Number of events 3 • Non-serious and serious adverse events were collected up to 7.5 months
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.
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
1/5 • Number of events 1 • Non-serious and serious adverse events were collected up to 7.5 months
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.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
20.0%
1/5 • Number of events 1 • Non-serious and serious adverse events were collected up to 7.5 months
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.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • Number of events 1 • Non-serious and serious adverse events were collected up to 7.5 months
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
1/5 • Number of events 1 • Non-serious and serious adverse events were collected up to 7.5 months
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.
|
|
Gastrointestinal disorders
Mouth ulceration
|
20.0%
1/5 • Number of events 1 • Non-serious and serious adverse events were collected up to 7.5 months
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.
|
|
Infections and infestations
Nasopharyngitis
|
60.0%
3/5 • Number of events 7 • Non-serious and serious adverse events were collected up to 7.5 months
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.
|
|
Infections and infestations
Oral candidiasis
|
20.0%
1/5 • Number of events 2 • Non-serious and serious adverse events were collected up to 7.5 months
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.
|
|
Infections and infestations
Sinusitis
|
20.0%
1/5 • Number of events 1 • Non-serious and serious adverse events were collected up to 7.5 months
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.
|
|
Infections and infestations
Fungal skin infection
|
20.0%
1/5 • Number of events 1 • Non-serious and serious adverse events were collected up to 7.5 months
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.
|
|
Infections and infestations
Skin bacterial infection
|
20.0%
1/5 • Number of events 1 • Non-serious and serious adverse events were collected up to 7.5 months
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.
|
|
Nervous system disorders
Headache
|
60.0%
3/5 • Number of events 22 • Non-serious and serious adverse events were collected up to 7.5 months
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.
|
|
Nervous system disorders
Migraine
|
20.0%
1/5 • Number of events 1 • Non-serious and serious adverse events were collected up to 7.5 months
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.
|
|
Immune system disorders
Seasonal allergy
|
40.0%
2/5 • Number of events 2 • Non-serious and serious adverse events were collected up to 7.5 months
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.
|
|
Injury, poisoning and procedural complications
Contusion
|
20.0%
1/5 • Number of events 1 • Non-serious and serious adverse events were collected up to 7.5 months
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.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
20.0%
1/5 • Number of events 1 • Non-serious and serious adverse events were collected up to 7.5 months
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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
1/5 • Number of events 1 • Non-serious and serious adverse events were collected up to 7.5 months
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.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
1/5 • Number of events 1 • Non-serious and serious adverse events were collected up to 7.5 months
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.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
20.0%
1/5 • Number of events 1 • Non-serious and serious adverse events were collected up to 7.5 months
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.
|
|
Metabolism and nutrition disorders
Vitamin B complex deficiency
|
20.0%
1/5 • Number of events 1 • Non-serious and serious adverse events were collected up to 7.5 months
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.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
20.0%
1/5 • Number of events 1 • Non-serious and serious adverse events were collected up to 7.5 months
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.
|
|
Product Issues
Product taste abnormal
|
20.0%
1/5 • Number of events 1 • Non-serious and serious adverse events were collected up to 7.5 months
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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
1/5 • Number of events 2 • Non-serious and serious adverse events were collected up to 7.5 months
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER