Trial Outcomes & Findings for An Efficacy Study of GSK2269557 Added to Standard Care in Subjects With an Acute Exacerbation of Chronic Obstructive Pulmonary Disease (NCT NCT02294734)
NCT ID: NCT02294734
Last Updated: 2021-08-12
Results Overview
siVaw is a measure of the volume in an individual's airway corrected for their lobar volume derived from the high resolution computed tomography (HRCT). It was measured at functional residual volume (FRC) and total lung capacity (TLC). Data was collected at longitudinal time points: Screening, Day 12 \& Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 \& D12D28. At each time point it was measure at 5 lobes (RUL, LUL, RML, RLL \& LLL) and 5 Regions (Upper, Lower, Central, Distal \& Total). For longitudinal time points and SCRD12 \& SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only particpants available at the specified time point were analysed (represented by n=X1, X2 in the category title).
COMPLETED
PHASE2
126 participants
Baseline, Day 12 and Day 28
2021-08-12
Participant Flow
The study consisted of a screening visit, a 12-week treatment period, and a 1-2 week post-treatment follow-up. The total duration of the study was 13-14 weeks including the screening visit.
Approximately 120 participants with an acute exacerbation of chronic obstructive pulmonary disease (COPD) were randomized (1:1) to GSK 2269557 1000 micrograms (µg) and placebo such that approximately 100 participants complete the study. Participants were also stratified by whether they were willing and able to provide sputum samples at screening.
Participant milestones
| Measure |
Placebo
Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
GSK2269557 1000 mcg
Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
|---|---|---|
|
Overall Study
STARTED
|
63
|
63
|
|
Overall Study
COMPLETED
|
49
|
55
|
|
Overall Study
NOT COMPLETED
|
14
|
8
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
GSK2269557 1000 mcg
Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
5
|
|
Overall Study
Met Protocol Defined Stopping Criteria
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Physician Decision
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
Baseline Characteristics
An Efficacy Study of GSK2269557 Added to Standard Care in Subjects With an Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Baseline characteristics by cohort
| Measure |
Placebo
n=63 Participants
Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
GSK2269557 1000 mcg
n=63 Participants
Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
Total
n=126 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.9 Years
STANDARD_DEVIATION 7.88 • n=5 Participants
|
65.6 Years
STANDARD_DEVIATION 7.14 • n=7 Participants
|
65.2 Years
STANDARD_DEVIATION 7.50 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
63 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 12 and Day 28Population: Intention to Treat (ITT) Population excluding the subject with a pacemaker.
siVaw is a measure of the volume in an individual's airway corrected for their lobar volume derived from the high resolution computed tomography (HRCT). It was measured at functional residual volume (FRC) and total lung capacity (TLC). Data was collected at longitudinal time points: Screening, Day 12 \& Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 \& D12D28. At each time point it was measure at 5 lobes (RUL, LUL, RML, RLL \& LLL) and 5 Regions (Upper, Lower, Central, Distal \& Total). For longitudinal time points and SCRD12 \& SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only particpants available at the specified time point were analysed (represented by n=X1, X2 in the category title).
Outcome measures
| Measure |
Placebo
n=62 Participants
Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
GSK2269557 1000 mcg
n=63 Participants
Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
|---|---|---|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; RUL; SCRD12 , n =54, 57
|
1.049 Milliliter/Liter (mL/L)
Interval 0.956 to 1.151
|
1.002 Milliliter/Liter (mL/L)
Interval 0.921 to 1.09
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; RUL; SCRD28 , n=56, 56
|
0.999 Milliliter/Liter (mL/L)
Interval 0.892 to 1.118
|
0.993 Milliliter/Liter (mL/L)
Interval 0.91 to 1.083
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; RUL; D12D28 , n =51, 55
|
0.931 Milliliter/Liter (mL/L)
Interval 0.858 to 1.01
|
0.995 Milliliter/Liter (mL/L)
Interval 0.933 to 1.062
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; LUL; SCRD12 , n =56, 59
|
0.979 Milliliter/Liter (mL/L)
Interval 0.891 to 1.077
|
1.012 Milliliter/Liter (mL/L)
Interval 0.938 to 1.092
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; LUL; SCRD28 , n=56, 58
|
0.952 Milliliter/Liter (mL/L)
Interval 0.862 to 1.051
|
1.018 Milliliter/Liter (mL/L)
Interval 0.934 to 1.11
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; LUL; D12D28 , n =53, 57
|
0.973 Milliliter/Liter (mL/L)
Interval 0.893 to 1.061
|
1.014 Milliliter/Liter (mL/L)
Interval 0.942 to 1.09
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; RML; SCRD12 , n =52, 58
|
0.924 Milliliter/Liter (mL/L)
Interval 0.811 to 1.052
|
0.977 Milliliter/Liter (mL/L)
Interval 0.878 to 1.087
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; RML; SCRD28 , n=53, 57
|
0.927 Milliliter/Liter (mL/L)
Interval 0.832 to 1.034
|
0.967 Milliliter/Liter (mL/L)
Interval 0.872 to 1.073
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; RML; D12D28 , n =52, 56
|
0.927 Milliliter/Liter (mL/L)
Interval 0.83 to 1.035
|
1.023 Milliliter/Liter (mL/L)
Interval 0.925 to 1.131
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; RLL; SCRD12 , n =54, 59
|
0.987 Milliliter/Liter (mL/L)
Interval 0.863 to 1.129
|
1.000 Milliliter/Liter (mL/L)
Interval 0.893 to 1.121
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; RLL; SCRD28 , n=55, 58
|
0.972 Milliliter/Liter (mL/L)
Interval 0.815 to 1.159
|
1.014 Milliliter/Liter (mL/L)
Interval 0.916 to 1.121
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; RLL; D12D28 , n =52, 57
|
0.920 Milliliter/Liter (mL/L)
Interval 0.829 to 1.02
|
1.015 Milliliter/Liter (mL/L)
Interval 0.918 to 1.121
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; LLL; SCRD12 , n =53, 58
|
1.031 Milliliter/Liter (mL/L)
Interval 0.925 to 1.149
|
1.050 Milliliter/Liter (mL/L)
Interval 0.939 to 1.173
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; LLL; SCRD28 , n=54, 58
|
1.034 Milliliter/Liter (mL/L)
Interval 0.893 to 1.198
|
1.064 Milliliter/Liter (mL/L)
Interval 0.958 to 1.18
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; LLL; D12D28 , n =51, 56
|
0.978 Milliliter/Liter (mL/L)
Interval 0.897 to 1.066
|
1.055 Milliliter/Liter (mL/L)
Interval 0.953 to 1.168
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Longitudinal;Region; Upper; D12 , n =56, 59
|
0.952 Milliliter/Liter (mL/L)
Interval 0.809 to 1.12
|
1.004 Milliliter/Liter (mL/L)
Interval 0.891 to 1.132
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Longitudinal; Region; Upper; D28 , n =56, 58
|
0.918 Milliliter/Liter (mL/L)
Interval 0.769 to 1.096
|
1.066 Milliliter/Liter (mL/L)
Interval 0.939 to 1.21
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Longitudinal; Region; Lower; D12 , n=54, 59
|
0.989 Milliliter/Liter (mL/L)
Interval 0.819 to 1.194
|
1.065 Milliliter/Liter (mL/L)
Interval 0.878 to 1.291
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Longitudinal; Region; Lower; D28 , n =55, 58
|
0.952 Milliliter/Liter (mL/L)
Interval 0.772 to 1.172
|
1.150 Milliliter/Liter (mL/L)
Interval 0.979 to 1.351
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Longitudinal; Region;Central; D12 , n =56, 59
|
0.969 Milliliter/Liter (mL/L)
Interval 0.886 to 1.06
|
1.021 Milliliter/Liter (mL/L)
Interval 0.963 to 1.083
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Longitudinal;Region; Central; D28 , n=56, 58
|
0.992 Milliliter/Liter (mL/L)
Interval 0.918 to 1.071
|
1.002 Milliliter/Liter (mL/L)
Interval 0.958 to 1.05
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Longitudinal; Region; Distal; D12 , n =56, 59
|
0.963 Milliliter/Liter (mL/L)
Interval 0.801 to 1.158
|
1.027 Milliliter/Liter (mL/L)
Interval 0.889 to 1.188
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Longitudinal; Region; Distal D28 , n =56, 58
|
0.939 Milliliter/Liter (mL/L)
Interval 0.778 to 1.134
|
1.098 Milliliter/Liter (mL/L)
Interval 0.959 to 1.258
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Longitudinal; Region;Total; D12, n =56, 59
|
0.970 Milliliter/Liter (mL/L)
Interval 0.881 to 1.068
|
1.018 Milliliter/Liter (mL/L)
Interval 0.955 to 1.085
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Longitudinal; Region; Total; D28 ,n =56, 58
|
0.989 Milliliter/Liter (mL/L)
Interval 0.911 to 1.074
|
1.009 Milliliter/Liter (mL/L)
Interval 0.959 to 1.061
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Region;Upper; SCRD12 ,n =56, 59
|
0.989 Milliliter/Liter (mL/L)
Interval 0.899 to 1.088
|
1.001 Milliliter/Liter (mL/L)
Interval 0.929 to 1.078
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Region;Upper; SCRD28 ,n=56, 58
|
0.962 Milliliter/Liter (mL/L)
Interval 0.878 to 1.054
|
1.007 Milliliter/Liter (mL/L)
Interval 0.925 to 1.096
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Region;Upper; D12D28 ,n =53, 57
|
0.967 Milliliter/Liter (mL/L)
Interval 0.889 to 1.051
|
1.011 Milliliter/Liter (mL/L)
Interval 0.949 to 1.077
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Region;Lower; SCRD12 ,n =54, 59
|
1.019 Milliliter/Liter (mL/L)
Interval 0.92 to 1.128
|
1.028 Milliliter/Liter (mL/L)
Interval 0.924 to 1.145
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Region; Lower; SCRD28 ,n=55, 58
|
1.002 Milliliter/Liter (mL/L)
Interval 0.868 to 1.157
|
1.039 Milliliter/Liter (mL/L)
Interval 0.944 to 1.144
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Region;Lower; D12D28 ,n =52, 57
|
0.953 Milliliter/Liter (mL/L)
Interval 0.873 to 1.04
|
1.008 Milliliter/Liter (mL/L)
Interval 0.92 to 1.104
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC;Scan Trimmed;Region;Central; SCRD12 ,n =56, 59
|
0.988 Milliliter/Liter (mL/L)
Interval 0.911 to 1.072
|
1.022 Milliliter/Liter (mL/L)
Interval 0.964 to 1.084
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC;Scan Trimmed; Region Central; SCRD28 ,n=56, 58
|
1.002 Milliliter/Liter (mL/L)
Interval 0.932 to 1.078
|
0.999 Milliliter/Liter (mL/L)
Interval 0.954 to 1.047
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC;Scan Trimmed;Region Central; D12D28 ,n =53, 57
|
0.998 Milliliter/Liter (mL/L)
Interval 0.942 to 1.057
|
0.977 Milliliter/Liter (mL/L)
Interval 0.932 to 1.025
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC;Scan Trimmed; Region;Distal; SCRD12 ,n =56, 59
|
0.998 Milliliter/Liter (mL/L)
Interval 0.903 to 1.104
|
1.009 Milliliter/Liter (mL/L)
Interval 0.925 to 1.099
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC;Scan Trimmed;Region; Distal; SCRD28 , n=56, 58
|
0.984 Milliliter/Liter (mL/L)
Interval 0.883 to 1.095
|
1.021 Milliliter/Liter (mL/L)
Interval 0.936 to 1.115
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC;Scan Trimmed;Region;Distal; D12D28 , n =53, 57
|
0.963 Milliliter/Liter (mL/L)
Interval 0.887 to 1.044
|
1.019 Milliliter/Liter (mL/L)
Interval 0.95 to 1.092
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC;Scan Trimmed; Region;Total; SCRD12 , n =56, 59
|
0.989 Milliliter/Liter (mL/L)
Interval 0.911 to 1.074
|
1.019 Milliliter/Liter (mL/L)
Interval 0.96 to 1.082
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC;Scan Trimmed;Region;Total; SCRD28 , n=56, 58
|
1.002 Milliliter/Liter (mL/L)
Interval 0.931 to 1.078
|
1.000 Milliliter/Liter (mL/L)
Interval 0.953 to 1.049
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
Trimmed;Region;Total; D12D28 , n =53, 57
|
0.995 Milliliter/Liter (mL/L)
Interval 0.94 to 1.054
|
0.982 Milliliter/Liter (mL/L)
Interval 0.936 to 1.03
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Longitudinal; Lobes; RUL; D12 , n =58, 57
|
1.048 Milliliter/Liter (mL/L)
Interval 0.951 to 1.154
|
0.976 Milliliter/Liter (mL/L)
Interval 0.912 to 1.043
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Longitudinal; Lobes; RUL; D28 , n =56, 57
|
1.045 Milliliter/Liter (mL/L)
Interval 0.927 to 1.179
|
0.979 Milliliter/Liter (mL/L)
Interval 0.908 to 1.055
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Longitudinal; Lobes; LUL; D12 , n=58, 59
|
1.043 Milliliter/Liter (mL/L)
Interval 0.933 to 1.166
|
1.007 Milliliter/Liter (mL/L)
Interval 0.936 to 1.083
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Longitudinal; Lobes; LUL; D28 , n =56, 59
|
1.078 Milliliter/Liter (mL/L)
Interval 0.922 to 1.26
|
1.027 Milliliter/Liter (mL/L)
Interval 0.947 to 1.115
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Longitudinal; Lobes; RML; D12 , n =57, 58
|
1.087 Milliliter/Liter (mL/L)
Interval 0.906 to 1.304
|
0.894 Milliliter/Liter (mL/L)
Interval 0.787 to 1.016
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Longitudinal; Lobes; RML; D28 , n=56, 58
|
1.084 Milliliter/Liter (mL/L)
Interval 0.893 to 1.317
|
0.903 Milliliter/Liter (mL/L)
Interval 0.808 to 1.008
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Longitudinal; Lobes; RLL; D12 , n =58, 59
|
1.038 Milliliter/Liter (mL/L)
Interval 0.884 to 1.219
|
0.906 Milliliter/Liter (mL/L)
Interval 0.82 to 1.001
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Longitudinal; Lobes; RLL; D28 , n =56, 59
|
1.014 Milliliter/Liter (mL/L)
Interval 0.839 to 1.227
|
0.948 Milliliter/Liter (mL/L)
Interval 0.858 to 1.048
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Longitudinal; Lobes; LLL; D12 , n =57, 59
|
1.074 Milliliter/Liter (mL/L)
Interval 0.917 to 1.258
|
0.934 Milliliter/Liter (mL/L)
Interval 0.844 to 1.035
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Longitudinal; Lobes; LLL; D28 ,n =55, 59
|
1.075 Milliliter/Liter (mL/L)
Interval 0.901 to 1.282
|
0.993 Milliliter/Liter (mL/L)
Interval 0.891 to 1.107
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; RUL; SCRD12 , n =58, 57
|
1.040 Milliliter/Liter (mL/L)
Interval 0.978 to 1.105
|
0.988 Milliliter/Liter (mL/L)
Interval 0.94 to 1.038
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; RUL; SCRD28 , n=56, 57
|
1.020 Milliliter/Liter (mL/L)
Interval 0.949 to 1.097
|
0.981 Milliliter/Liter (mL/L)
Interval 0.925 to 1.04
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; RUL; D12D28 , n =55, 56
|
0.971 Milliliter/Liter (mL/L)
Interval 0.908 to 1.039
|
1.002 Milliliter/Liter (mL/L)
Interval 0.956 to 1.05
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; LUL; SCRD12 , n =58, 59
|
1.022 Milliliter/Liter (mL/L)
Interval 0.961 to 1.088
|
1.001 Milliliter/Liter (mL/L)
Interval 0.95 to 1.055
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Longitudinal; Lobes; RUL; D12 , n =54, 57
|
1.033 Milliliter/Liter (mL/L)
Interval 0.851 to 1.255
|
1.052 Milliliter/Liter (mL/L)
Interval 0.924 to 1.197
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Longitudinal; Lobes; RUL; D28 , n =56, 56
|
0.983 Milliliter/Liter (mL/L)
Interval 0.775 to 1.246
|
1.075 Milliliter/Liter (mL/L)
Interval 0.94 to 1.23
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Longitudinal; Lobes; LUL; D12 , n=56, 59
|
0.975 Milliliter/Liter (mL/L)
Interval 0.817 to 1.165
|
1.000 Milliliter/Liter (mL/L)
Interval 0.877 to 1.14
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Longitudinal; Lobes; LUL; D28 , n =56, 58
|
0.893 Milliliter/Liter (mL/L)
Interval 0.745 to 1.07
|
1.090 Milliliter/Liter (mL/L)
Interval 0.932 to 1.275
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Longitudinal; Lobes; RML; D12 , n =52, 58
|
0.956 Milliliter/Liter (mL/L)
Interval 0.806 to 1.135
|
0.871 Milliliter/Liter (mL/L)
Interval 0.691 to 1.097
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Longitudinal; Lobes; RML; D28 , n=53, 57
|
0.853 Milliliter/Liter (mL/L)
Interval 0.677 to 1.075
|
1.006 Milliliter/Liter (mL/L)
Interval 0.867 to 1.167
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Longitudinal; Lobes; RLL; D12 , n =54, 59
|
0.908 Milliliter/Liter (mL/L)
Interval 0.684 to 1.204
|
1.115 Milliliter/Liter (mL/L)
Interval 0.885 to 1.405
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Longitudinal; Lobes; RLL; D28 , n =55, 58
|
0.871 Milliliter/Liter (mL/L)
Interval 0.652 to 1.164
|
1.167 Milliliter/Liter (mL/L)
Interval 0.975 to 1.397
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Longitudinal; Lobes; LLL; D12 , n =53, 58
|
1.051 Milliliter/Liter (mL/L)
Interval 0.885 to 1.248
|
1.087 Milliliter/Liter (mL/L)
Interval 0.892 to 1.323
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Longitudinal; Lobes; LLL; D28 ,n =54, 58
|
1.000 Milliliter/Liter (mL/L)
Interval 0.806 to 1.242
|
1.199 Milliliter/Liter (mL/L)
Interval 0.999 to 1.438
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; LUL; SCRD28 , n=56, 59
|
1.035 Milliliter/Liter (mL/L)
Interval 0.962 to 1.113
|
0.991 Milliliter/Liter (mL/L)
Interval 0.933 to 1.052
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; LUL; D12D28 , n =55, 58
|
1.007 Milliliter/Liter (mL/L)
Interval 0.933 to 1.086
|
1.002 Milliliter/Liter (mL/L)
Interval 0.956 to 1.05
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; RML; SCRD12 , n =57, 58
|
1.029 Milliliter/Liter (mL/L)
Interval 0.948 to 1.116
|
0.934 Milliliter/Liter (mL/L)
Interval 0.87 to 1.003
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; RML; SCRD28 , n=56, 58
|
1.020 Milliliter/Liter (mL/L)
Interval 0.933 to 1.116
|
0.932 Milliliter/Liter (mL/L)
Interval 0.877 to 0.991
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; RML; D12D28 , n =55, 57
|
0.980 Milliliter/Liter (mL/L)
Interval 0.904 to 1.063
|
1.008 Milliliter/Liter (mL/L)
Interval 0.942 to 1.078
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; RLL; SCRD12 , n =58, 59
|
1.022 Milliliter/Liter (mL/L)
Interval 0.94 to 1.112
|
0.932 Milliliter/Liter (mL/L)
Interval 0.871 to 0.996
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; RLL; SCRD28 , n=56, 59
|
0.984 Milliliter/Liter (mL/L)
Interval 0.897 to 1.078
|
0.944 Milliliter/Liter (mL/L)
Interval 0.884 to 1.008
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; RLL; D12D28 , n =55, 58
|
0.962 Milliliter/Liter (mL/L)
Interval 0.881 to 1.051
|
1.027 Milliliter/Liter (mL/L)
Interval 0.98 to 1.076
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; LLL; SCRD12 , n =57, 59
|
1.024 Milliliter/Liter (mL/L)
Interval 0.939 to 1.117
|
0.967 Milliliter/Liter (mL/L)
Interval 0.908 to 1.03
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; LLL; SCRD28 , n=55, 59
|
1.025 Milliliter/Liter (mL/L)
Interval 0.933 to 1.125
|
0.972 Milliliter/Liter (mL/L)
Interval 0.907 to 1.043
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; LLL; D12D28 , n =54, 58
|
0.984 Milliliter/Liter (mL/L)
Interval 0.911 to 1.062
|
1.017 Milliliter/Liter (mL/L)
Interval 0.97 to 1.065
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Longitudinal;Region; Upper; D12 , n =58, 59
|
1.031 Milliliter/Liter (mL/L)
Interval 0.935 to 1.137
|
0.983 Milliliter/Liter (mL/L)
Interval 0.922 to 1.049
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Longitudinal; Region; Upper; D28 , n =56, 59
|
1.046 Milliliter/Liter (mL/L)
Interval 0.918 to 1.191
|
0.995 Milliliter/Liter (mL/L)
Interval 0.928 to 1.067
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Longitudinal; Region; Lower; D12 , n=58, 59
|
1.051 Milliliter/Liter (mL/L)
Interval 0.909 to 1.215
|
0.924 Milliliter/Liter (mL/L)
Interval 0.84 to 1.017
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Longitudinal; Region; Lower; D28 , n =56, 59
|
1.037 Milliliter/Liter (mL/L)
Interval 0.879 to 1.223
|
0.974 Milliliter/Liter (mL/L)
Interval 0.883 to 1.074
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Longitudinal; Region;Central; D12 , n =58, 59
|
1.001 Milliliter/Liter (mL/L)
Interval 0.971 to 1.033
|
0.991 Milliliter/Liter (mL/L)
Interval 0.971 to 1.012
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Longitudinal;Region; Central; D28 , n=56, 59
|
1.006 Milliliter/Liter (mL/L)
Interval 0.979 to 1.033
|
0.992 Milliliter/Liter (mL/L)
Interval 0.972 to 1.013
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Longitudinal; Region; Distal; D12 , n =58, 59
|
1.043 Milliliter/Liter (mL/L)
Interval 0.931 to 1.168
|
0.949 Milliliter/Liter (mL/L)
Interval 0.883 to 1.021
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Longitudinal; Region; Distal D28 , n =56, 59
|
1.039 Milliliter/Liter (mL/L)
Interval 0.902 to 1.197
|
0.982 Milliliter/Liter (mL/L)
Interval 0.91 to 1.06
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Longitudinal; Region;Total; D12, n =58, 59
|
1.009 Milliliter/Liter (mL/L)
Interval 0.969 to 1.051
|
0.982 Milliliter/Liter (mL/L)
Interval 0.958 to 1.006
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Longitudinal; Region; Total; D28 ,n =56, 59
|
1.005 Milliliter/Liter (mL/L)
Interval 0.967 to 1.044
|
0.988 Milliliter/Liter (mL/L)
Interval 0.964 to 1.013
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Region;Upper; SCRD12 ,n =58, 59
|
1.028 Milliliter/Liter (mL/L)
Interval 0.969 to 1.09
|
0.992 Milliliter/Liter (mL/L)
Interval 0.944 to 1.041
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Region;Upper; SCRD28 ,n=56, 59
|
1.021 Milliliter/Liter (mL/L)
Interval 0.953 to 1.095
|
0.984 Milliliter/Liter (mL/L)
Interval 0.932 to 1.04
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Region;Upper; D12D28 ,n =55, 58
|
0.985 Milliliter/Liter (mL/L)
Interval 0.922 to 1.054
|
1.003 Milliliter/Liter (mL/L)
Interval 0.962 to 1.046
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Region;Lower; SCRD12 ,n =58, 59
|
1.021 Milliliter/Liter (mL/L)
Interval 0.943 to 1.105
|
0.954 Milliliter/Liter (mL/L)
Interval 0.897 to 1.014
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Region; Lower; SCRD28 ,n=56, 59
|
0.996 Milliliter/Liter (mL/L)
Interval 0.916 to 1.083
|
0.960 Milliliter/Liter (mL/L)
Interval 0.899 to 1.025
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Region;Lower; D12D28 ,n =55, 58
|
0.972 Milliliter/Liter (mL/L)
Interval 0.899 to 1.052
|
1.018 Milliliter/Liter (mL/L)
Interval 0.977 to 1.06
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC;Scan Trimmed;Region;Central; SCRD12 ,n =58, 59
|
1.000 Milliliter/Liter (mL/L)
Interval 0.972 to 1.029
|
0.997 Milliliter/Liter (mL/L)
Interval 0.975 to 1.02
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC;Scan Trimmed; Region Central; SCRD28 ,n=56, 59
|
1.005 Milliliter/Liter (mL/L)
Interval 0.981 to 1.03
|
0.995 Milliliter/Liter (mL/L)
Interval 0.972 to 1.018
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC;Scan Trimmed;Region Central; D12D28 ,n =55, 58
|
1.004 Milliliter/Liter (mL/L)
Interval 0.981 to 1.028
|
0.998 Milliliter/Liter (mL/L)
Interval 0.984 to 1.012
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC;Scan Trimmed; Region;Distal; SCRD12 ,n =58, 59
|
1.025 Milliliter/Liter (mL/L)
Interval 0.96 to 1.095
|
0.972 Milliliter/Liter (mL/L)
Interval 0.922 to 1.025
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC;Scan Trimmed;Region; Distal; SCRD28 , n=56, 59
|
1.008 Milliliter/Liter (mL/L)
Interval 0.936 to 1.086
|
0.972 Milliliter/Liter (mL/L)
Interval 0.919 to 1.029
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC;Scan Trimmed;Region;Distal; D12D28 , n =55, 58
|
0.978 Milliliter/Liter (mL/L)
Interval 0.912 to 1.05
|
1.011 Milliliter/Liter (mL/L)
Interval 0.973 to 1.051
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC;Scan Trimmed; Region;Total; SCRD12 , n =58, 59
|
1.005 Milliliter/Liter (mL/L)
Interval 0.973 to 1.037
|
0.991 Milliliter/Liter (mL/L)
Interval 0.967 to 1.017
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC;Scan Trimmed;Region;Total; SCRD28 , n=56, 59
|
1.004 Milliliter/Liter (mL/L)
Interval 0.976 to 1.032
|
0.989 Milliliter/Liter (mL/L)
Interval 0.965 to 1.014
|
|
Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed;Region;Total; D12D28 , n =55, 58
|
0.997 Milliliter/Liter (mL/L)
Interval 0.97 to 1.025
|
1.000 Milliliter/Liter (mL/L)
Interval 0.984 to 1.017
|
SECONDARY outcome
Timeframe: Baseline, Day 12 and Day 28Population: ITT Population excluding the subject with a pacemaker.
iVaw was derived from HRCT to evaluate the effect of once daily inhaled dose of GSK2269557 on lung parameters. Data was collected at longitudinal time points: Screening, Day 12 \& Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 \& D12D28. At each time point it was measure at 5 lobes (RUL, LUL, RML, RLL \& LLL) and 5 Regions (Upper, Lower, Central, Distal \& Total). For longitudinal time points and SCRD12 \& SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only particpants available at the specified time point were analysed (represented by n=X1, X2 in the category title).
Outcome measures
| Measure |
Placebo
n=62 Participants
Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
GSK2269557 1000 mcg
n=63 Participants
Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
|---|---|---|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Longitudinal; Lobes; RUL; D12 , n =54, 59
|
1.020 Milliliter (mL)
Interval 0.838 to 1.242
|
1.058 Milliliter (mL)
Interval 0.93 to 1.203
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Longitudinal; Lobes; RUL; D28 , n =56, 58
|
0.960 Milliliter (mL)
Interval 0.755 to 1.22
|
1.121 Milliliter (mL)
Interval 0.965 to 1.301
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Longitudinal; Lobes; LUL; D12 , n=56, 59
|
0.951 Milliliter (mL)
Interval 0.789 to 1.145
|
0.999 Milliliter (mL)
Interval 0.866 to 1.151
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Longitudinal; Lobes; LUL; D28 , n =56, 58
|
0.876 Milliliter (mL)
Interval 0.727 to 1.055
|
1.108 Milliliter (mL)
Interval 0.938 to 1.309
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Longitudinal; Lobes; RML; D12 , n =53, 59
|
0.905 Milliliter (mL)
Interval 0.746 to 1.098
|
0.869 Milliliter (mL)
Interval 0.694 to 1.089
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Longitudinal; Lobes; RML; D28 , n=53, 58
|
0.835 Milliliter (mL)
Interval 0.655 to 1.064
|
1.013 Milliliter (mL)
Interval 0.87 to 1.18
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Longitudinal; Lobes; RLL; D12 , n =54, 59
|
0.889 Milliliter (mL)
Interval 0.669 to 1.182
|
1.119 Milliliter (mL)
Interval 0.892 to 1.404
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Longitudinal; Lobes; RLL; D28 , n =55, 58
|
0.850 Milliliter (mL)
Interval 0.634 to 1.14
|
1.177 Milliliter (mL)
Interval 0.977 to 1.417
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Longitudinal; Lobes; LLL; D12 , n =53, 58
|
1.017 Milliliter (mL)
Interval 0.853 to 1.212
|
1.067 Milliliter (mL)
Interval 0.881 to 1.293
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Longitudinal; Lobes; LLL; D28 ,n =54, 58
|
0.980 Milliliter (mL)
Interval 0.784 to 1.226
|
1.187 Milliliter (mL)
Interval 0.992 to 1.421
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; RUL; SCRD12 , n =54, 59
|
1.035 Milliliter (mL)
Interval 0.942 to 1.137
|
1.006 Milliliter (mL)
Interval 0.927 to 1.091
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; RUL; SCRD28 , n=56, 58
|
0.976 Milliliter (mL)
Interval 0.872 to 1.091
|
1.027 Milliliter (mL)
Interval 0.938 to 1.124
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; RUL; D12D28 , n =51, 57
|
0.927 Milliliter (mL)
Interval 0.861 to 0.997
|
1.018 Milliliter (mL)
Interval 0.948 to 1.092
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; LUL; SCRD12 , n =56, 59
|
0.954 Milliliter (mL)
Interval 0.87 to 1.048
|
1.010 Milliliter (mL)
Interval 0.932 to 1.095
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; LUL; SCRD28 , n=56, 58
|
0.933 Milliliter (mL)
Interval 0.846 to 1.029
|
1.035 Milliliter (mL)
Interval 0.946 to 1.133
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; LUL; D12D28 , n =53, 57
|
0.981 Milliliter (mL)
Interval 0.902 to 1.068
|
1.029 Milliliter (mL)
Interval 0.956 to 1.107
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; RML; SCRD12 , n =53, 59
|
0.905 Milliliter (mL)
Interval 0.798 to 1.027
|
0.970 Milliliter (mL)
Interval 0.872 to 1.079
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; RML; SCRD28 , n=53, 58
|
0.907 Milliliter (mL)
Interval 0.807 to 1.02
|
0.972 Milliliter (mL)
Interval 0.876 to 1.079
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; RML; D12D28 , n =52, 57
|
0.927 Milliliter (mL)
Interval 0.833 to 1.032
|
1.031 Milliliter (mL)
Interval 0.933 to 1.139
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; RLL; SCRD12 , n =54, 59
|
0.968 Milliliter (mL)
Interval 0.849 to 1.102
|
1.004 Milliliter (mL)
Interval 0.905 to 1.113
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; RLL; SCRD28 , n=55, 58
|
0.948 Milliliter (mL)
Interval 0.796 to 1.131
|
1.022 Milliliter (mL)
Interval 0.925 to 1.13
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; RLL; D12D28 , n =52, 57
|
0.916 Milliliter (mL)
Interval 0.837 to 1.002
|
1.018 Milliliter (mL)
Interval 0.92 to 1.125
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; LLL; SCRD12 , n =53, 58
|
0.997 Milliliter (mL)
Interval 0.898 to 1.108
|
1.031 Milliliter (mL)
Interval 0.935 to 1.136
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; LLL; SCRD28 , n=54, 58
|
1.013 Milliliter (mL)
Interval 0.869 to 1.182
|
1.054 Milliliter (mL)
Interval 0.954 to 1.164
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; LLL; D12D28 , n =51, 56
|
0.989 Milliliter (mL)
Interval 0.922 to 1.061
|
1.061 Milliliter (mL)
Interval 0.962 to 1.17
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Longitudinal;Region; Upper; D12 , n =56, 59
|
0.933 Milliliter (mL)
Interval 0.789 to 1.104
|
1.000 Milliliter (mL)
Interval 0.882 to 1.133
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Longitudinal; Region; Upper; D28 , n =56, 58
|
0.898 Milliliter (mL)
Interval 0.749 to 1.077
|
1.079 Milliliter (mL)
Interval 0.943 to 1.236
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Longitudinal; Region; Lower; D12 , n=54, 59
|
0.965 Milliliter (mL)
Interval 0.798 to 1.166
|
1.058 Milliliter (mL)
Interval 0.878 to 1.275
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Longitudinal; Region; Lower; D28 , n =55, 58
|
0.931 Milliliter (mL)
Interval 0.751 to 1.153
|
1.151 Milliliter (mL)
Interval 0.978 to 1.354
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Longitudinal; Region;Central; D12 , n =56, 59
|
0.945 Milliliter (mL)
Interval 0.863 to 1.035
|
1.016 Milliliter (mL)
Interval 0.961 to 1.074
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Longitudinal;Region; Cetral; D28 , n=56, 58
|
0.968 Milliliter (mL)
Interval 0.892 to 1.05
|
1.010 Milliliter (mL)
Interval 0.961 to 1.062
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Longitudinal; Region; Distal; D12 , n =56, 59
|
0.939 Milliliter (mL)
Interval 0.779 to 1.132
|
1.022 Milliliter (mL)
Interval 0.883 to 1.182
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Longitudinal; Region; Distal D28 , n =56, 58
|
0.917 Milliliter (mL)
Interval 0.757 to 1.11
|
1.107 Milliliter (mL)
Interval 0.961 to 1.276
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Longitudinal; Region;Total; D12 n =56, 59
|
0.946 Milliliter (mL)
Interval 0.858 to 1.043
|
1.012 Milliliter (mL)
Interval 0.951 to 1.077
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Longitudinal; Region; Total; D28 ,n =56, 58
|
0.966 Milliliter (mL)
Interval 0.885 to 1.053
|
1.017 Milliliter (mL)
Interval 0.961 to 1.076
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Region;Upper; SCRD12 ,n =56, 59
|
0.969 Milliliter (mL)
Interval 0.881 to 1.067
|
0.997 Milliliter (mL)
Interval 0.923 to 1.076
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Region;Upper; SCRD28 ,n=56, 58
|
0.941 Milliliter (mL)
Interval 0.86 to 1.03
|
1.019 Milliliter (mL)
Interval 0.934 to 1.112
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Region;Upper; D12D28 ,n =53, 57
|
0.968 Milliliter (mL)
Interval 0.893 to 1.049
|
1.025 Milliliter (mL)
Interval 0.96 to 1.095
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Region;Lower; SCRD12 ,n =54, 59
|
0.994 Milliliter (mL)
Interval 0.902 to 1.096
|
1.022 Milliliter (mL)
Interval 0.929 to 1.124
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Region; Lower; SCRD28 ,n=55, 58
|
0.980 Milliliter (mL)
Interval 0.846 to 1.135
|
1.040 Milliliter (mL)
Interval 0.948 to 1.14
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Region;Lower; D12D28 ,n =52, 57
|
0.954 Milliliter (mL)
Interval 0.889 to 1.02
|
1.013 Milliliter (mL)
Interval 0.928 to 1.106
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC;Scan Trimmed;Region;Central; SCRD12 ,n =56, 59
|
0.964 Milliliter (mL)
Interval 0.891 to 1.044
|
1.016 Milliliter (mL)
Interval 0.967 to 1.069
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC;Scan Trimmed; Region Central; SCRD28 ,n=56, 58
|
0.978 Milliliter (mL)
Interval 0.908 to 1.054
|
1.007 Milliliter (mL)
Interval 0.966 to 1.051
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC;Scan Trimmed;Region Central; D12D28 ,n =53, 57
|
1.000 Milliliter (mL)
Interval 0.95 to 1.053
|
0.988 Milliliter (mL)
Interval 0.946 to 1.033
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC;Scan Trimmed; Region;Distal; SCRD12 ,n =56, 59
|
0.974 Milliliter (mL)
Interval 0.882 to 1.074
|
1.003 Milliliter (mL)
Interval 0.923 to 1.089
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC;Scan Trimmed;Region; Distal; SCRD28 , n=56, 58
|
0.960 Milliliter (mL)
Interval 0.862 to 1.07
|
1.030 Milliliter (mL)
Interval 0.944 to 1.123
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC;Scan Trimmed;Region;Distal; D12D28 , n =53, 57
|
0.965 Milliliter (mL)
Interval 0.897 to 1.039
|
1.030 Milliliter (mL)
Interval 0.961 to 1.105
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC;Scan Trimmed; Region;Total; SCRD12 , n =56, 59
|
0.965 Milliliter (mL)
Interval 0.891 to 1.045
|
1.014 Milliliter (mL)
Interval 0.963 to 1.067
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC;Scan Trimmed;Region;Total; SCRD28 , n=56, 58
|
0.978 Milliliter (mL)
Interval 0.908 to 1.054
|
1.008 Milliliter (mL)
Interval 0.964 to 1.053
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed;Region;Total; D12D28 , n =53, 57
|
0.998 Milliliter (mL)
Interval 0.949 to 1.049
|
0.993 Milliliter (mL)
Interval 0.949 to 1.039
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Longitudinal; Lobes; RUL; D12 , n =58, 59
|
1.057 Milliliter (mL)
Interval 0.954 to 1.172
|
0.982 Milliliter (mL)
Interval 0.917 to 1.051
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Longitudinal; Lobes; RUL; D28 , n =56, 59
|
1.050 Milliliter (mL)
Interval 0.92 to 1.198
|
0.989 Milliliter (mL)
Interval 0.916 to 1.068
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Longitudinal; Lobes; LUL; D12 , n=58, 59
|
1.045 Milliliter (mL)
Interval 0.929 to 1.175
|
1.005 Milliliter (mL)
Interval 0.932 to 1.084
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Longitudinal; Lobes; LUL; D28 , n =56, 59
|
1.082 Milliliter (mL)
Interval 0.913 to 1.282
|
1.025 Milliliter (mL)
Interval 0.942 to 1.116
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Longitudinal; Lobes; RML; D12 , n =58, 59
|
1.045 Milliliter (mL)
Interval 0.861 to 1.268
|
0.887 Milliliter (mL)
Interval 0.779 to 1.009
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Longitudinal; Lobes; RML; D28 , n=56, 59
|
1.076 Milliliter (mL)
Interval 0.872 to 1.328
|
0.906 Milliliter (mL)
Interval 0.81 to 1.012
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Longitudinal; Lobes; RLL; D12 , n =58, 59
|
1.049 Milliliter (mL)
Interval 0.889 to 1.238
|
0.910 Milliliter (mL)
Interval 0.817 to 1.014
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Longitudinal; Lobes; RLL; D28 , n =56, 59
|
1.014 Milliliter (mL)
Interval 0.826 to 1.244
|
0.956 Milliliter (mL)
Interval 0.854 to 1.071
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Longitudinal; Lobes; LLL; D12, n =57, 59
|
1.082 Milliliter (mL)
Interval 0.911 to 1.286
|
0.924 Milliliter (mL)
Interval 0.827 to 1.031
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Longitudinal; Lobes; LLL; D28 ,n =55, 59
|
1.077 Milliliter (mL)
Interval 0.888 to 1.306
|
0.989 Milliliter (mL)
Interval 0.879 to 1.112
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; RUL; SCRD12 , n =58, 59
|
1.049 Milliliter (mL)
Interval 0.982 to 1.121
|
0.994 Milliliter (mL)
Interval 0.945 to 1.046
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; RUL; SCRD28 , n=56, 59
|
1.025 Milliliter (mL)
Interval 0.944 to 1.113
|
0.987 Milliliter (mL)
Interval 0.932 to 1.046
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; RUL; D12D28 , n =55, 58
|
0.966 Milliliter (mL)
Interval 0.898 to 1.039
|
1.002 Milliliter (mL)
Interval 0.957 to 1.05
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; LUL; SCRD12 , n =58, 59
|
1.024 Milliliter (mL)
Interval 0.958 to 1.095
|
0.999 Milliliter (mL)
Interval 0.946 to 1.055
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; LUL; SCRD28 , n=56, 59
|
1.039 Milliliter (mL)
Interval 0.954 to 1.132
|
0.989 Milliliter (mL)
Interval 0.929 to 1.052
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; LUL; D12D28 , n =55, 58
|
1.008 Milliliter (mL)
Interval 0.929 to 1.095
|
1.002 Milliliter (mL)
Interval 0.957 to 1.049
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; RML; SCRD12 , n =58, 59
|
1.017 Milliliter (mL)
Interval 0.937 to 1.105
|
0.926 Milliliter (mL)
Interval 0.861 to 0.996
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; RML; SCRD28 , n=56, 59
|
1.013 Milliliter (mL)
Interval 0.915 to 1.121
|
0.935 Milliliter (mL)
Interval 0.879 to 0.995
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; RML; D12D28 , n =55, 58
|
0.974 Milliliter (mL)
Interval 0.898 to 1.057
|
1.021 Milliliter (mL)
Interval 0.955 to 1.09
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; RLL; SCRD12 , n =58, 59
|
1.032 Milliliter (mL)
Interval 0.947 to 1.126
|
0.936 Milliliter (mL)
Interval 0.875 to 1.001
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; RLL; SCRD28 , n=56, 59
|
0.983 Milliliter (mL)
Interval 0.884 to 1.094
|
0.952 Milliliter (mL)
Interval 0.892 to 1.016
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; RLL; D12D28 , n =55, 58
|
0.953 Milliliter (mL)
Interval 0.868 to 1.047
|
1.033 Milliliter (mL)
Interval 0.986 to 1.082
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; LLL; SCRD12 , n =57, 59
|
1.032 Milliliter (mL)
Interval 0.94 to 1.133
|
0.956 Milliliter (mL)
Interval 0.895 to 1.022
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; LLL; SCRD28 , n=55, 59
|
1.027 Milliliter (mL)
Interval 0.919 to 1.147
|
0.968 Milliliter (mL)
Interval 0.904 to 1.037
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; LLL; D12D28 , n =54, 58
|
0.976 Milliliter (mL)
Interval 0.906 to 1.052
|
1.025 Milliliter (mL)
Interval 0.976 to 1.077
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Longitudinal;Region; Upper; D12 , n =58, 59
|
1.037 Milliliter (mL)
Interval 0.934 to 1.151
|
0.981 Milliliter (mL)
Interval 0.917 to 1.049
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Longitudinal; Region; Upper; D28 , n =56, 59
|
1.049 Milliliter (mL)
Interval 0.909 to 1.211
|
0.994 Milliliter (mL)
Interval 0.924 to 1.069
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Longitudinal; Region; Lower; D12 , n=58, 59
|
1.061 Milliliter (mL)
Interval 0.911 to 1.235
|
0.921 Milliliter (mL)
Interval 0.83 to 1.022
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Longitudinal; Region; Lower; D28 , n =56, 59
|
1.037 Milliliter (mL)
Interval 0.867 to 1.241
|
0.977 Milliliter (mL)
Interval 0.876 to 1.089
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Longitudinal; Region;Central; D12 , n =58, 59
|
1.006 Milliliter (mL)
Interval 0.972 to 1.042
|
0.988 Milliliter (mL)
Interval 0.97 to 1.007
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Longitudinal;Region; Cetral; D28 , n=56, 59
|
1.007 Milliliter (mL)
Interval 0.968 to 1.049
|
0.993 Milliliter (mL)
Interval 0.973 to 1.013
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Longitudinal; Region; Distal; D12 , n =58, 59
|
1.048 Milliliter (mL)
Interval 0.93 to 1.182
|
0.947 Milliliter (mL)
Interval 0.876 to 1.023
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Longitudinal; Region; Distal D28 , n =56, 59
|
1.041 Milliliter (mL)
Interval 0.891 to 1.215
|
0.983 Milliliter (mL)
Interval 0.905 to 1.067
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Longitudinal; Region;Total; D12, n =58, 59
|
1.014 Milliliter (mL)
Interval 0.968 to 1.062
|
0.979 Milliliter (mL)
Interval 0.954 to 1.004
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Longitudinal; Region; Total; D28 ,n =56, 59
|
1.007 Milliliter (mL)
Interval 0.955 to 1.061
|
0.989 Milliliter (mL)
Interval 0.963 to 1.016
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Region;Upper; SCRD12 ,n =58, 59
|
1.033 Milliliter (mL)
Interval 0.969 to 1.102
|
0.989 Milliliter (mL)
Interval 0.94 to 1.041
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Region;Upper; SCRD28 ,n=56, 59
|
1.025 Milliliter (mL)
Interval 0.945 to 1.111
|
0.983 Milliliter (mL)
Interval 0.929 to 1.04
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Region;Upper; D12D28 ,n =55, 58
|
0.983 Milliliter (mL)
Interval 0.915 to 1.055
|
1.006 Milliliter (mL)
Interval 0.964 to 1.049
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Region;Lower; SCRD12 ,n =58, 59
|
1.030 Milliliter (mL)
Interval 0.949 to 1.118
|
0.951 Milliliter (mL)
Interval 0.894 to 1.011
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Region; Lower; SCRD28 ,n=56, 59
|
0.997 Milliliter (mL)
Interval 0.904 to 1.099
|
0.963 Milliliter (mL)
Interval 0.903 to 1.027
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Region;Lower; D12D28 ,n =55, 58
|
0.964 Milliliter (mL)
Interval 0.889 to 1.045
|
1.025 Milliliter (mL)
Interval 0.985 to 1.067
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC;Scan Trimmed;Region;Central; SCRD12 ,n =58, 59
|
1.005 Milliliter (mL)
Interval 0.973 to 1.037
|
0.994 Milliliter (mL)
Interval 0.976 to 1.013
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC;Scan Trimmed; Region Central; SCRD28 ,n=56, 59
|
1.007 Milliliter (mL)
Interval 0.971 to 1.044
|
0.995 Milliliter (mL)
Interval 0.977 to 1.014
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC;Scan Trimmed;Region Central; D12D28 ,n =55, 58
|
1.000 Milliliter (mL)
Interval 0.98 to 1.022
|
1.003 Milliliter (mL)
Interval 0.991 to 1.015
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC;Scan Trimmed; Region;Distal; SCRD12 ,n =58, 59
|
1.030 Milliliter (mL)
Interval 0.961 to 1.105
|
0.969 Milliliter (mL)
Interval 0.918 to 1.023
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC;Scan Trimmed;Region; Distal; SCRD28 , n=56, 59
|
1.010 Milliliter (mL)
Interval 0.927 to 1.1
|
0.973 Milliliter (mL)
Interval 0.919 to 1.03
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC;Scan Trimmed;Region;Distal; D12D28 , n =55, 58
|
0.975 Milliliter (mL)
Interval 0.906 to 1.04
|
1.016 Milliliter (mL)
Interval 0.978 to 1.057
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC;Scan Trimmed; Region;Total; SCRD12 , n =58, 59
|
1.010 Milliliter (mL)
Interval 0.974 to 1.046
|
0.989 Milliliter (mL)
Interval 0.967 to 1.011
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC;Scan Trimmed;Region;Total; SCRD28 , n=56, 59
|
1.006 Milliliter (mL)
Interval 0.966 to 1.047
|
0.990 Milliliter (mL)
Interval 0.968 to 1.012
|
|
Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed;Region;Total; D12D28 , n =55, 58
|
0.993 Milliliter (mL)
Interval 0.968 to 1.019
|
1.005 Milliliter (mL)
Interval 0.99 to 1.02
|
SECONDARY outcome
Timeframe: Baseline, Day 12 and Day 28Population: ITT Population excluding the subject with a pacemaker.
iRaw was derived from HRCT to evaluate the effect of once daily inhaled dose of GSK2269557 on lung parameters. It was measured at functional residual volume (FRC) and total lung capacity (TLC). Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 \& D12D28. At each time point it was measure at 5 lobes (RUL, LUL, RML, RLL \& LLL) and 5 Regions (Upper, Lower, Central, Distal \& Total). For SCRD12 \& SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only particpants available at the specified time point were analysed (represented by n=X1, X2 in the category title).
Outcome measures
| Measure |
Placebo
n=62 Participants
Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
GSK2269557 1000 mcg
n=63 Participants
Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
|---|---|---|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; RUL; SCRD12 , n =54, 59
|
0.908 Kilopascal (Kpa)*s/L
Interval 0.62 to 1.33
|
0.948 Kilopascal (Kpa)*s/L
Interval 0.693 to 1.296
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; RUL; SCRD28 , n=56, 58
|
0.849 Kilopascal (Kpa)*s/L
Interval 0.529 to 1.362
|
0.958 Kilopascal (Kpa)*s/L
Interval 0.701 to 1.309
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; RUL; D12D28 , n =51, 57
|
1.039 Kilopascal (Kpa)*s/L
Interval 0.715 to 1.51
|
0.898 Kilopascal (Kpa)*s/L
Interval 0.697 to 1.157
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; LUL; SCRD12 , n =56, 59
|
0.982 Kilopascal (Kpa)*s/L
Interval 0.687 to 1.403
|
0.946 Kilopascal (Kpa)*s/L
Interval 0.706 to 1.267
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; LUL; SCRD28 , n=56, 58
|
0.937 Kilopascal (Kpa)*s/L
Interval 0.62 to 1.417
|
0.820 Kilopascal (Kpa)*s/L
Interval 0.568 to 1.186
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; LUL; D12D28 , n =53, 57
|
0.842 Kilopascal (Kpa)*s/L
Interval 0.603 to 1.176
|
0.934 Kilopascal (Kpa)*s/L
Interval 0.703 to 1.241
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; RML; SCRD12 , n =53, 59
|
1.022 Kilopascal (Kpa)*s/L
Interval 0.667 to 1.568
|
0.998 Kilopascal (Kpa)*s/L
Interval 0.656 to 1.52
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; RML; SCRD28 , n=53, 58
|
1.378 Kilopascal (Kpa)*s/L
Interval 0.865 to 2.196
|
0.886 Kilopascal (Kpa)*s/L
Interval 0.632 to 1.24
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; RML; D12D28 , n =52, 57
|
1.027 Kilopascal (Kpa)*s/L
Interval 0.692 to 1.523
|
1.198 Kilopascal (Kpa)*s/L
Interval 0.811 to 1.769
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; RLL; SCRD12 , n =54, 59
|
1.100 Kilopascal (Kpa)*s/L
Interval 0.705 to 1.716
|
1.043 Kilopascal (Kpa)*s/L
Interval 0.673 to 1.617
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; RLL; SCRD28 , n=55, 58
|
1.504 Kilopascal (Kpa)*s/L
Interval 1.011 to 2.237
|
1.044 Kilopascal (Kpa)*s/L
Interval 0.728 to 1.497
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; RLL; D12D28 , n =52, 57
|
1.289 Kilopascal (Kpa)*s/L
Interval 0.953 to 1.745
|
1.126 Kilopascal (Kpa)*s/L
Interval 0.773 to 1.641
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; LLL; SCRD12 , n =53, 58
|
0.781 Kilopascal (Kpa)*s/L
Interval 0.522 to 1.167
|
0.738 Kilopascal (Kpa)*s/L
Interval 0.491 to 1.109
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; LLL; SCRD28 , n=54, 58
|
0.949 Kilopascal (Kpa)*s/L
Interval 0.637 to 1.414
|
0.818 Kilopascal (Kpa)*s/L
Interval 0.546 to 1.227
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; LLL; D12D28 , n =51, 56
|
1.051 Kilopascal (Kpa)*s/L
Interval 0.818 to 1.35
|
1.012 Kilopascal (Kpa)*s/L
Interval 0.7 to 1.465
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Region;Upper; SCRD12 ,n =56, 59
|
0.934 Kilopascal (Kpa)*s/L
Interval 0.656 to 1.329
|
0.960 Kilopascal (Kpa)*s/L
Interval 0.735 to 1.255
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Region;Upper; SCRD28 ,n=56, 58
|
0.940 Kilopascal (Kpa)*s/L
Interval 0.629 to 1.404
|
0.887 Kilopascal (Kpa)*s/L
Interval 0.643 to 1.222
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Region;Upper; D12D28 ,n =53, 57
|
0.869 Kilopascal (Kpa)*s/L
Interval 0.617 to 1.223
|
1.127 Kilopascal (Kpa)*s/L
Interval 0.834 to 1.52
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Region;Lower; SCRD12 ,n =54, 59
|
0.845 Kilopascal (Kpa)*s/L
Interval 0.543 to 1.314
|
0.821 Kilopascal (Kpa)*s/L
Interval 0.531 to 1.27
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Region; Lower; SCRD28 ,n=55, 58
|
1.215 Kilopascal (Kpa)*s/L
Interval 0.835 to 1.766
|
0.868 Kilopascal (Kpa)*s/L
Interval 0.606 to 1.243
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Region;Lower; D12D28 ,n =52, 57
|
1.113 Kilopascal (Kpa)*s/L
Interval 0.887 to 1.396
|
1.193 Kilopascal (Kpa)*s/L
Interval 0.805 to 1.766
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC;Scan Trimmed;Region;Central; SCRD12 ,n =56, 59
|
1.104 Kilopascal (Kpa)*s/L
Interval 0.832 to 1.464
|
0.933 Kilopascal (Kpa)*s/L
Interval 0.769 to 1.133
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC;Scan Trimmed; Region Central; SCRD28 ,n=56, 58
|
1.079 Kilopascal (Kpa)*s/L
Interval 0.794 to 1.465
|
0.950 Kilopascal (Kpa)*s/L
Interval 0.81 to 1.114
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC;Scan Trimmed;Region Central; D12D28 ,n =53, 57
|
1.033 Kilopascal (Kpa)*s/L
Interval 0.851 to 1.253
|
1.010 Kilopascal (Kpa)*s/L
Interval 0.854 to 1.195
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC;Scan Trimmed; Region;Distal; SCRD12 ,n =56, 59
|
0.800 Kilopascal (Kpa)*s/L
Interval 0.546 to 1.174
|
0.859 Kilopascal (Kpa)*s/L
Interval 0.6 to 1.23
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC;Scan Trimmed;Region; Distal; SCRD28 , n=56, 58
|
0.993 Kilopascal (Kpa)*s/L
Interval 0.675 to 1.459
|
0.873 Kilopascal (Kpa)*s/L
Interval 0.636 to 1.199
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC;Scan Trimmed;Region;Distal; D12D28 , n =53, 57
|
0.887 Kilopascal (Kpa)*s/L
Interval 0.67 to 1.175
|
1.220 Kilopascal (Kpa)*s/L
Interval 0.89 to 1.674
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC;Scan Trimmed; Region;Total; SCRD12 , n =56, 59
|
1.006 Kilopascal (Kpa)*s/L
Interval 0.76 to 1.333
|
0.919 Kilopascal (Kpa)*s/L
Interval 0.738 to 1.145
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC;Scan Trimmed;Region;Total; SCRD28 , n=56, 58
|
1.036 Kilopascal (Kpa)*s/L
Interval 0.758 to 1.417
|
0.922 Kilopascal (Kpa)*s/L
Interval 0.75 to 1.132
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed;Region;Total; D12D28 , n =53, 57
|
1.000 Kilopascal (Kpa)*s/L
Interval 0.82 to 1.22
|
1.066 Kilopascal (Kpa)*s/L
Interval 0.875 to 1.298
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; RUL; SCRD12 , n =56, 59
|
0.843 Kilopascal (Kpa)*s/L
Interval 0.677 to 1.049
|
0.978 Kilopascal (Kpa)*s/L
Interval 0.81 to 1.181
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; RUL; SCRD28 , n=56, 58
|
0.929 Kilopascal (Kpa)*s/L
Interval 0.714 to 1.21
|
1.019 Kilopascal (Kpa)*s/L
Interval 0.826 to 1.258
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; RUL; D12D28 , n =53, 57
|
1.152 Kilopascal (Kpa)*s/L
Interval 0.953 to 1.391
|
0.901 Kilopascal (Kpa)*s/L
Interval 0.759 to 1.069
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; LUL; SCRD12 , n =56, 59
|
0.879 Kilopascal (Kpa)*s/L
Interval 0.717 to 1.077
|
0.979 Kilopascal (Kpa)*s/L
Interval 0.829 to 1.156
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; LUL; SCRD28 , n=56, 58
|
0.922 Kilopascal (Kpa)*s/L
Interval 0.726 to 1.173
|
0.886 Kilopascal (Kpa)*s/L
Interval 0.687 to 1.141
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; LUL; D12D28 , n =53, 57
|
1.025 Kilopascal (Kpa)*s/L
Interval 0.857 to 1.226
|
0.894 Kilopascal (Kpa)*s/L
Interval 0.75 to 1.066
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; RML; SCRD12 , n =57, 58
|
1.076 Kilopascal (Kpa)*s/L
Interval 0.834 to 1.388
|
1.349 Kilopascal (Kpa)*s/L
Interval 1.001 to 1.816
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; RML; SCRD28 , n=56, 59
|
0.989 Kilopascal (Kpa)*s/L
Interval 0.722 to 1.355
|
1.220 Kilopascal (Kpa)*s/L
Interval 0.909 to 1.637
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; RML; D12D28 , n =56, 58
|
1.102 Kilopascal (Kpa)*s/L
Interval 0.869 to 1.397
|
0.988 Kilopascal (Kpa)*s/L
Interval 0.771 to 1.266
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; RLL; SCRD12 , n =56, 59
|
0.848 Kilopascal (Kpa)*s/L
Interval 0.587 to 1.225
|
1.143 Kilopascal (Kpa)*s/L
Interval 0.9 to 1.451
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; RLL; SCRD28 , n=56, 58
|
0.965 Kilopascal (Kpa)*s/L
Interval 0.688 to 1.352
|
1.122 Kilopascal (Kpa)*s/L
Interval 0.868 to 1.452
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; RLL; D12D28 , n =53, 57
|
1.208 Kilopascal (Kpa)*s/L
Interval 0.941 to 1.55
|
0.927 Kilopascal (Kpa)*s/L
Interval 0.775 to 1.109
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; LLL; SCRD12 , n =55, 59
|
0.813 Kilopascal (Kpa)*s/L
Interval 0.605 to 1.093
|
1.139 Kilopascal (Kpa)*s/L
Interval 0.893 to 1.453
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; LLL; SCRD28 , n=55, 58
|
0.958 Kilopascal (Kpa)*s/L
Interval 0.682 to 1.346
|
0.987 Kilopascal (Kpa)*s/L
Interval 0.758 to 1.285
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; LLL; D12D28 , n=52, 57
|
1.313 Kilopascal (Kpa)*s/L
Interval 1.022 to 1.686
|
0.829 Kilopascal (Kpa)*s/L
Interval 0.67 to 1.026
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Region;Upper; SCRD12 ,n =56, 59
|
0.913 Kilopascal (Kpa)*s/L
Interval 0.754 to 1.106
|
1.103 Kilopascal (Kpa)*s/L
Interval 0.911 to 1.335
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Region;Upper; SCRD28 ,n=56, 58
|
0.958 Kilopascal (Kpa)*s/L
Interval 0.751 to 1.222
|
0.957 Kilopascal (Kpa)*s/L
Interval 0.764 to 1.2
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Region;Upper; D12D28 ,n =53, 57
|
1.067 Kilopascal (Kpa)*s/L
Interval 0.896 to 1.27
|
0.885 Kilopascal (Kpa)*s/L
Interval 0.752 to 1.04
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Region;Lower; SCRD12 ,n =56, 59
|
0.850 Kilopascal (Kpa)*s/L
Interval 0.621 to 1.163
|
1.116 Kilopascal (Kpa)*s/L
Interval 0.897 to 1.388
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Region; Lower; SCRD28 ,n=56, 58
|
0.953 Kilopascal (Kpa)*s/L
Interval 0.676 to 1.344
|
1.056 Kilopascal (Kpa)*s/L
Interval 0.827 to 1.347
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Region;Lower; D12D28 ,n =53, 57
|
1.269 Kilopascal (Kpa)*s/L
Interval 1.021 to 1.578
|
0.862 Kilopascal (Kpa)*s/L
Interval 0.723 to 1.028
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC;Scan Trimmed;Region;Central; SCRD12 ,n =56, 59
|
0.960 Kilopascal (Kpa)*s/L
Interval 0.841 to 1.095
|
1.007 Kilopascal (Kpa)*s/L
Interval 0.937 to 1.081
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC;Scan Trimmed; Region Central; SCRD28 ,n=56, 58
|
0.976 Kilopascal (Kpa)*s/L
Interval 0.838 to 1.136
|
1.000 Kilopascal (Kpa)*s/L
Interval 0.933 to 1.07
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC;Scan Trimmed;Region Central; D12D28 ,n =53, 57
|
1.039 Kilopascal (Kpa)*s/L
Interval 0.945 to 1.142
|
0.981 Kilopascal (Kpa)*s/L
Interval 0.932 to 1.032
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC;Scan Trimmed; Region;Distal; SCRD12 ,n =56, 59
|
0.889 Kilopascal (Kpa)*s/L
Interval 0.68 to 1.161
|
1.116 Kilopascal (Kpa)*s/L
Interval 0.913 to 1.364
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC;Scan Trimmed;Region; Distal; SCRD28 , n=56, 58
|
0.945 Kilopascal (Kpa)*s/L
Interval 0.698 to 1.279
|
0.976 Kilopascal (Kpa)*s/L
Interval 0.793 to 1.201
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC;Scan Trimmed;Region;Distal; D12D28 , n =53, 57
|
1.189 Kilopascal (Kpa)*s/L
Interval 1.0 to 1.414
|
0.838 Kilopascal (Kpa)*s/L
Interval 0.719 to 0.976
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC;Scan Trimmed; Region;Total; SCRD12 , n =56, 59
|
0.891 Kilopascal (Kpa)*s/L
Interval 0.762 to 1.042
|
1.061 Kilopascal (Kpa)*s/L
Interval 0.937 to 1.202
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC;Scan Trimmed;Region;Total; SCRD28 , n=56, 58
|
0.956 Kilopascal (Kpa)*s/L
Interval 0.781 to 1.171
|
0.989 Kilopascal (Kpa)*s/L
Interval 0.861 to 1.136
|
|
Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed;Region;Total; D12D28 , n =53, 57
|
1.133 Kilopascal (Kpa)*s/L
Interval 0.99 to 1.296
|
0.904 Kilopascal (Kpa)*s/L
Interval 0.816 to 1.002
|
SECONDARY outcome
Timeframe: Baseline, Day 12 and Day 28Population: ITT Population excluding the subject with a pacemaker.
siRaw was derived from HRCT to evaluate the effect of once daily inhaled dose of GSK2269557 on lung parameters. It was measured at functional residual volume (FRC) and total lung capacity (TLC). Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 \& D12D28. At each time point it was measure at 5 lobes (RUL, LUL, RML, RLL \& LLL) and 5 Regions (Upper, Lower, Central, Distal \& Total). For SCRD12 \& SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only particpants available at the specified time point were analysed (represented by n=X1, X2 in the category title).
Outcome measures
| Measure |
Placebo
n=62 Participants
Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
GSK2269557 1000 mcg
n=63 Participants
Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
|---|---|---|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; RUL; SCRD12 , n =54, 57
|
0.896 Kpa*s
Interval 0.613 to 1.31
|
0.908 Kpa*s
Interval 0.669 to 1.231
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; RUL; SCRD28 , n=56, 56
|
0.829 Kpa*s
Interval 0.516 to 1.333
|
1.013 Kpa*s
Interval 0.757 to 1.355
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; RUL; D12D28 , n =51, 55
|
1.035 Kpa*s
Interval 0.712 to 1.505
|
0.926 Kpa*s
Interval 0.72 to 1.191
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; LUL; SCRD12 , n =56, 59
|
0.957 Kpa*s
Interval 0.671 to 1.365
|
0.944 Kpa*s
Interval 0.715 to 1.247
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; LUL; SCRD28 , n=56, 58
|
0.919 Kpa*s
Interval 0.61 to 1.383
|
0.834 Kpa*s
Interval 0.585 to 1.189
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; LUL; D12D28 , n =53, 57
|
0.849 Kpa*s
Interval 0.608 to 1.184
|
0.948 Kpa*s
Interval 0.717 to 1.254
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; RML; SCRD12 , n =52, 58
|
1.009 Kpa*s
Interval 0.655 to 1.553
|
1.013 Kpa*s
Interval 0.669 to 1.533
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; RML; SCRD28 , n=53, 57
|
1.349 Kpa*s
Interval 0.856 to 2.125
|
0.904 Kpa*s
Interval 0.649 to 1.261
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; RML; D12D28 , n =52, 56
|
1.028 Kpa*s
Interval 0.695 to 1.521
|
1.213 Kpa*s
Interval 0.818 to 1.798
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; RLL; SCRD12 , n =54, 59
|
1.078 Kpa*s
Interval 0.687 to 1.691
|
1.046 Kpa*s
Interval 0.671 to 1.632
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; RLL; SCRD28 , n=55, 58
|
1.468 Kpa*s
Interval 0.99 to 2.177
|
1.053 Kpa*s
Interval 0.736 to 1.507
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; RLL; D12D28 , n =52, 57
|
1.284 Kpa*s
Interval 0.94 to 1.754
|
1.130 Kpa*s
Interval 0.778 to 1.641
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; LLL; SCRD12 , n =53, 58
|
0.755 Kpa*s
Interval 0.506 to 1.127
|
0.725 Kpa*s
Interval 0.479 to 1.098
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; LLL; SCRD28 , n=54, 58
|
0.930 Kpa*s
Interval 0.629 to 1.375
|
0.811 Kpa*s
Interval 0.539 to 1.22
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Lobes; LLL; D12D28 , n =51, 56
|
1.063 Kpa*s
Interval 0.829 to 1.362
|
1.017 Kpa*s
Interval 0.702 to 1.476
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Region;Upper; SCRD12 ,n =56, 59
|
0.915 Kpa*s
Interval 0.645 to 1.3
|
0.956 Kpa*s
Interval 0.74 to 1.237
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Region;Upper; SCRD28 ,n=56, 58
|
0.919 Kpa*s
Interval 0.617 to 1.37
|
0.898 Kpa*s
Interval 0.659 to 1.223
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Region;Upper; D12D28 ,n =53, 57
|
0.870 Kpa*s
Interval 0.62 to 1.22
|
1.142 Kpa*s
Interval 0.849 to 1.536
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Region;Lower; SCRD12 ,n =54, 59
|
0.825 Kpa*s
Interval 0.53 to 1.283
|
0.816 Kpa*s
Interval 0.524 to 1.27
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Region; Lower; SCRD28 ,n=55, 58
|
1.188 Kpa*s
Interval 0.821 to 1.718
|
0.869 Kpa*s
Interval 0.606 to 1.246
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed; Region;Lower; D12D28 ,n =52, 57
|
1.114 Kpa*s
Interval 0.881 to 1.409
|
1.200 Kpa*s
Interval 0.81 to 1.777
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC;Scan Trimmed;Region;Central; SCRD12 ,n =56, 59
|
1.077 Kpa*s
Interval 0.813 to 1.425
|
0.928 Kpa*s
Interval 0.762 to 1.13
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC;Scan Trimmed; Region Central; SCRD28 ,n=56, 58
|
1.053 Kpa*s
Interval 0.777 to 1.427
|
0.957 Kpa*s
Interval 0.817 to 1.121
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC;Scan Trimmed;Region Central; D12D28 ,n =53, 57
|
1.035 Kpa*s
Interval 0.851 to 1.259
|
1.022 Kpa*s
Interval 0.863 to 1.21
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC;Scan Trimmed; Region;Distal; SCRD12 ,n =56, 59
|
0.781 Kpa*s
Interval 0.533 to 1.144
|
0.854 Kpa*s
Interval 0.598 to 1.22
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC;Scan Trimmed;Region; Distal; SCRD28 , n=56, 58
|
0.969 Kpa*s
Interval 0.661 to 1.421
|
0.880 Kpa*s
Interval 0.645 to 1.202
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC;Scan Trimmed;Region;Distal; D12D28 , n =53, 57
|
0.890 Kpa*s
Interval 0.672 to 1.179
|
1.234 Kpa*s
Interval 0.903 to 1.687
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC;Scan Trimmed; Region;Total; SCRD12 , n =56, 59
|
0.982 Kpa*s
Interval 0.741 to 1.3
|
0.914 Kpa*s
Interval 0.732 to 1.14
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC;Scan Trimmed;Region;Total; SCRD28 , n=56, 58
|
1.012 Kpa*s
Interval 0.742 to 1.378
|
0.929 Kpa*s
Interval 0.76 to 1.136
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
FRC; Scan Trimmed;Region;Total; D12D28 , n =53, 57
|
1.003 Kpa*s
Interval 0.821 to 1.225
|
1.078 Kpa*s
Interval 0.886 to 1.311
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; RUL; SCRD12 , n =56, 59
|
0.848 Kpa*s
Interval 0.686 to 1.049
|
0.989 Kpa*s
Interval 0.816 to 1.198
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; RUL; SCRD28 , n=56, 58
|
0.934 Kpa*s
Interval 0.725 to 1.203
|
1.043 Kpa*s
Interval 0.846 to 1.285
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; RUL; D12D28 , n =53, 57
|
1.142 Kpa*s
Interval 0.945 to 1.379
|
0.903 Kpa*s
Interval 0.757 to 1.077
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; LUL; SCRD12 , n =56, 59
|
0.880 Kpa*s
Interval 0.721 to 1.074
|
0.977 Kpa*s
Interval 0.832 to 1.148
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; LUL; SCRD28 , n=56, 58
|
0.926 Kpa*s
Interval 0.736 to 1.165
|
0.885 Kpa*s
Interval 0.69 to 1.134
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; LUL; D12D28 , n =53, 57
|
1.023 Kpa*s
Interval 0.856 to 1.221
|
0.896 Kpa*s
Interval 0.751 to 1.069
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; RML; SCRD12 , n =57, 58
|
1.073 Kpa*s
Interval 0.829 to 1.39
|
1.343 Kpa*s
Interval 0.995 to 1.814
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; RML; SCRD28 , n=56, 59
|
0.981 Kpa*s
Interval 0.727 to 1.324
|
1.238 Kpa*s
Interval 0.921 to 1.664
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; RML; D12D28 , n =56, 58
|
1.093 Kpa*s
Interval 0.867 to 1.377
|
1.010 Kpa*s
Interval 0.782 to 1.303
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; RLL; SCRD12 , n =56, 59
|
0.854 Kpa*s
Interval 0.595 to 1.226
|
1.149 Kpa*s
Interval 0.91 to 1.449
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; RLL; SCRD28 , n=56, 58
|
0.964 Kpa*s
Interval 0.695 to 1.337
|
1.134 Kpa*s
Interval 0.887 to 1.45
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; RLL; D12D28 , n =53, 57
|
1.192 Kpa*s
Interval 0.937 to 1.518
|
0.935 Kpa*s
Interval 0.782 to 1.117
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; LLL; SCRD12 , n =55, 59
|
0.820 Kpa*s
Interval 0.617 to 1.089
|
1.126 Kpa*s
Interval 0.891 to 1.424
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; LLL; SCRD28 , n=55, 58
|
0.960 Kpa*s
Interval 0.69 to 1.335
|
0.985 Kpa*s
Interval 0.76 to 1.276
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Lobes; LLL; D12D28 , n=52, 57
|
1.302 Kpa*s
Interval 1.013 to 1.674
|
0.839 Kpa*s
Interval 0.679 to 1.037
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Region;Upper; SCRD12 ,n =56, 59
|
0.917 Kpa*s
Interval 0.76 to 1.106
|
1.100 Kpa*s
Interval 0.912 to 1.327
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Region;Upper; SCRD28 ,n=56, 58
|
0.961 Kpa*s
Interval 0.762 to 1.213
|
0.957 Kpa*s
Interval 0.767 to 1.195
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Region;Upper; D12D28 ,n =53, 57
|
1.060 Kpa*s
Interval 0.891 to 1.262
|
0.888 Kpa*s
Interval 0.755 to 1.045
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Region;Lower; SCRD12 ,n =56, 59
|
0.856 Kpa*s
Interval 0.631 to 1.162
|
1.112 Kpa*s
Interval 0.9 to 1.374
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Region; Lower; SCRD28 ,n=56, 58
|
0.954 Kpa*s
Interval 0.683 to 1.332
|
1.061 Kpa*s
Interval 0.838 to 1.342
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed; Region;Lower; D12D28 ,n =53, 57
|
1.256 Kpa*s
Interval 1.015 to 1.553
|
0.871 Kpa*s
Interval 0.731 to 1.038
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC;Scan Trimmed;Region;Central; SCRD12 ,n =56, 59
|
0.963 Kpa*s
Interval 0.85 to 1.092
|
1.004 Kpa*s
Interval 0.931 to 1.083
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC;Scan Trimmed; Region Central; SCRD28 ,n=56, 58
|
0.977 Kpa*s
Interval 0.852 to 1.121
|
1.002 Kpa*s
Interval 0.927 to 1.082
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC;Scan Trimmed;Region Central; D12D28 ,n =53, 57
|
1.032 Kpa*s
Interval 0.939 to 1.135
|
0.988 Kpa*s
Interval 0.941 to 1.037
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC;Scan Trimmed; Region;Distal; SCRD12 ,n =56, 59
|
0.892 Kpa*s
Interval 0.688 to 1.157
|
1.112 Kpa*s
Interval 0.915 to 1.353
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC;Scan Trimmed;Region; Distal; SCRD28 , n=56, 58
|
0.946 Kpa*s
Interval 0.705 to 1.27
|
0.978 Kpa*s
Interval 0.8 to 1.195
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC;Scan Trimmed;Region;Distal; D12D28 , n =53, 57
|
1.181 Kpa*s
Interval 0.996 to 1.401
|
0.844 Kpa*s
Interval 0.724 to 0.983
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC;Scan Trimmed; Region;Total; SCRD12 , n =56, 59
|
0.895 Kpa*s
Interval 0.771 to 1.038
|
1.058 Kpa*s
Interval 0.938 to 1.194
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC;Scan Trimmed;Region;Total; SCRD28 , n=56, 58
|
0.958 Kpa*s
Interval 0.793 to 1.158
|
0.991 Kpa*s
Interval 0.867 to 1.133
|
|
Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28
TLC; Scan Trimmed;Region;Total; D12D28 , n =53, 57
|
1.125 Kpa*s
Interval 0.986 to 1.285
|
0.911 Kpa*s
Interval 0.822 to 1.008
|
SECONDARY outcome
Timeframe: Baseline, Day 12 and Day 28Population: ITT Population excluding the subject with a pacemaker.
Change from Baseline in lung lobar volumes was measured at functional residual volume (FRC) and total lung capacity (TLC) scan conditions. Data was collected at longitudinal time points: Day 12 \& Day 28. At each time point it was measure at 5 lobes (RUL, LUL, RML, RLL \& LLL) and 5 Regions (Upper, Lower, Central, Distal \& Total). For longitudinal time points the baseline is screening. Change from baseline is the post-Baseline value minus the Baseline value. Only particpants available at the specified time point were analysed (represented by n=X1, X2 in the category title).
Outcome measures
| Measure |
Placebo
n=62 Participants
Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
GSK2269557 1000 mcg
n=63 Participants
Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
|---|---|---|
|
Change From Baseline in Lung Lobar Volumes Measured at FRC and TLC Scan Conditions, Presented in Longitudinal Scan Types, Measured in 5 Lobes and 5 Regions at Day 12 and Day 28
FRC Lobes; RUL; Day 12, n =56, 57
|
0.983 L
Interval 0.953 to 1.014
|
0.995 L
Interval 0.964 to 1.026
|
|
Change From Baseline in Lung Lobar Volumes Measured at FRC and TLC Scan Conditions, Presented in Longitudinal Scan Types, Measured in 5 Lobes and 5 Regions at Day 12 and Day 28
FRC Lobes; RUL Day 28, n =56, 56
|
0.977 L
Interval 0.949 to 1.005
|
1.017 L
Interval 0.985 to 1.05
|
|
Change From Baseline in Lung Lobar Volumes Measured at FRC and TLC Scan Conditions, Presented in Longitudinal Scan Types, Measured in 5 Lobes and 5 Regions at Day 12 and Day 28
FRC Lobes; LUL Day 12, n =56, 59
|
0.974 L
Interval 0.943 to 1.007
|
0.998 L
Interval 0.964 to 1.034
|
|
Change From Baseline in Lung Lobar Volumes Measured at FRC and TLC Scan Conditions, Presented in Longitudinal Scan Types, Measured in 5 Lobes and 5 Regions at Day 12 and Day 28
FRC Lobes;LUL Day 28, n =56, 58
|
0.980 L
Interval 0.953 to 1.009
|
1.017 L
Interval 0.978 to 1.057
|
|
Change From Baseline in Lung Lobar Volumes Measured at FRC and TLC Scan Conditions, Presented in Longitudinal Scan Types, Measured in 5 Lobes and 5 Regions at Day 12 and Day 28
FRC Lobes; RML Day 12, n =55, 58
|
0.981 L
Interval 0.943 to 1.022
|
0.992 L
Interval 0.959 to 1.025
|
|
Change From Baseline in Lung Lobar Volumes Measured at FRC and TLC Scan Conditions, Presented in Longitudinal Scan Types, Measured in 5 Lobes and 5 Regions at Day 12 and Day 28
FRC Lobes; RML Day 28, n =56, 57
|
0.972 L
Interval 0.943 to 1.002
|
0.996 L
Interval 0.963 to 1.03
|
|
Change From Baseline in Lung Lobar Volumes Measured at FRC and TLC Scan Conditions, Presented in Longitudinal Scan Types, Measured in 5 Lobes and 5 Regions at Day 12 and Day 28
FRC Lobes; RLL Day 12, n =56, 59
|
0.977 L
Interval 0.933 to 1.024
|
1.004 L
Interval 0.964 to 1.045
|
|
Change From Baseline in Lung Lobar Volumes Measured at FRC and TLC Scan Conditions, Presented in Longitudinal Scan Types, Measured in 5 Lobes and 5 Regions at Day 12 and Day 28
FRC Lobes; RLL Day 28, n =56, 58
|
0.972 L
Interval 0.939 to 1.007
|
1.009 L
Interval 0.968 to 1.051
|
|
Change From Baseline in Lung Lobar Volumes Measured at FRC and TLC Scan Conditions, Presented in Longitudinal Scan Types, Measured in 5 Lobes and 5 Regions at Day 12 and Day 28
FRC Lobes; LLL Day 12, n =55, 59
|
0.968 L
Interval 0.934 to 1.004
|
0.983 L
Interval 0.944 to 1.024
|
|
Change From Baseline in Lung Lobar Volumes Measured at FRC and TLC Scan Conditions, Presented in Longitudinal Scan Types, Measured in 5 Lobes and 5 Regions at Day 12 and Day 28
FRC Lobes; LLL Day 28, n =55, 58
|
0.979 L
Interval 0.948 to 1.01
|
0.991 L
Interval 0.95 to 1.033
|
|
Change From Baseline in Lung Lobar Volumes Measured at FRC and TLC Scan Conditions, Presented in Longitudinal Scan Types, Measured in 5 Lobes and 5 Regions at Day 12 and Day 28
FRC Region; Upper Day 12, n =56, 59
|
0.980 L
Interval 0.95 to 1.011
|
0.996 L
Interval 0.966 to 1.027
|
|
Change From Baseline in Lung Lobar Volumes Measured at FRC and TLC Scan Conditions, Presented in Longitudinal Scan Types, Measured in 5 Lobes and 5 Regions at Day 12 and Day 28
FRC Region; Upper Day 28, n =56, 58
|
0.978 L
Interval 0.954 to 1.004
|
1.013 L
Interval 0.979 to 1.047
|
|
Change From Baseline in Lung Lobar Volumes Measured at FRC and TLC Scan Conditions, Presented in Longitudinal Scan Types, Measured in 5 Lobes and 5 Regions at Day 12 and Day 28
FRC Region; Lower Day 12, n =56, 59
|
0.975 L
Interval 0.936 to 1.016
|
0.994 L
Interval 0.956 to 1.033
|
|
Change From Baseline in Lung Lobar Volumes Measured at FRC and TLC Scan Conditions, Presented in Longitudinal Scan Types, Measured in 5 Lobes and 5 Regions at Day 12 and Day 28
FRC Region; Lower Day 28, n =56, 58
|
0.975 L
Interval 0.945 to 1.007
|
1.001 L
Interval 0.962 to 1.041
|
|
Change From Baseline in Lung Lobar Volumes Measured at FRC and TLC Scan Conditions, Presented in Longitudinal Scan Types, Measured in 5 Lobes and 5 Regions at Day 12 and Day 28
FRC Region; Total Day 12, n =56, 59
|
0.975 L
Interval 0.944 to 1.007
|
0.994 L
Interval 0.964 to 1.026
|
|
Change From Baseline in Lung Lobar Volumes Measured at FRC and TLC Scan Conditions, Presented in Longitudinal Scan Types, Measured in 5 Lobes and 5 Regions at Day 12 and Day 28
FRC Region; Total Day 28, n =56, 58
|
0.976 L
Interval 0.95 to 1.003
|
1.008 L
Interval 0.974 to 1.042
|
|
Change From Baseline in Lung Lobar Volumes Measured at FRC and TLC Scan Conditions, Presented in Longitudinal Scan Types, Measured in 5 Lobes and 5 Regions at Day 12 and Day 28
TLC Lobes; RUL; Day 12, n =58, 57
|
1.009 L
Interval 0.994 to 1.024
|
0.999 L
Interval 0.986 to 1.011
|
|
Change From Baseline in Lung Lobar Volumes Measured at FRC and TLC Scan Conditions, Presented in Longitudinal Scan Types, Measured in 5 Lobes and 5 Regions at Day 12 and Day 28
TLC Lobes; RUL Day 28, n =56, 57
|
1.005 L
Interval 0.985 to 1.025
|
0.999 L
Interval 0.984 to 1.013
|
|
Change From Baseline in Lung Lobar Volumes Measured at FRC and TLC Scan Conditions, Presented in Longitudinal Scan Types, Measured in 5 Lobes and 5 Regions at Day 12 and Day 28
TLC Lobes; LUL Day 12, n =58, 59
|
1.002 L
Interval 0.989 to 1.014
|
0.998 L
Interval 0.984 to 1.013
|
|
Change From Baseline in Lung Lobar Volumes Measured at FRC and TLC Scan Conditions, Presented in Longitudinal Scan Types, Measured in 5 Lobes and 5 Regions at Day 12 and Day 28
TLC Lobes;LUL Day 28, n =56, 59
|
1.004 L
Interval 0.984 to 1.025
|
0.998 L
Interval 0.982 to 1.014
|
|
Change From Baseline in Lung Lobar Volumes Measured at FRC and TLC Scan Conditions, Presented in Longitudinal Scan Types, Measured in 5 Lobes and 5 Regions at Day 12 and Day 28
TLC Lobes; RML Day 12, n =57, 58
|
0.998 L
Interval 0.975 to 1.021
|
0.988 L
Interval 0.97 to 1.005
|
|
Change From Baseline in Lung Lobar Volumes Measured at FRC and TLC Scan Conditions, Presented in Longitudinal Scan Types, Measured in 5 Lobes and 5 Regions at Day 12 and Day 28
TLC Lobes; RML Day 28, n =56, 58
|
0.992 L
Interval 0.96 to 1.025
|
0.996 L
Interval 0.979 to 1.013
|
|
Change From Baseline in Lung Lobar Volumes Measured at FRC and TLC Scan Conditions, Presented in Longitudinal Scan Types, Measured in 5 Lobes and 5 Regions at Day 12 and Day 28
TLC Lobes; RLL Day 12, n =58, 59
|
1.010 L
Interval 0.983 to 1.038
|
1.005 L
Interval 0.977 to 1.034
|
|
Change From Baseline in Lung Lobar Volumes Measured at FRC and TLC Scan Conditions, Presented in Longitudinal Scan Types, Measured in 5 Lobes and 5 Regions at Day 12 and Day 28
TLC Lobes; RLL Day 28, n =56, 59
|
1.000 L
Interval 0.974 to 1.026
|
1.009 L
Interval 0.975 to 1.044
|
|
Change From Baseline in Lung Lobar Volumes Measured at FRC and TLC Scan Conditions, Presented in Longitudinal Scan Types, Measured in 5 Lobes and 5 Regions at Day 12 and Day 28
TLC Lobes; LLL Day 12, n =57, 59
|
1.008 L
Interval 0.975 to 1.042
|
0.989 L
Interval 0.964 to 1.014
|
|
Change From Baseline in Lung Lobar Volumes Measured at FRC and TLC Scan Conditions, Presented in Longitudinal Scan Types, Measured in 5 Lobes and 5 Regions at Day 12 and Day 28
TLC Lobes; LLL Day 28, n =55, 59
|
1.002 L
Interval 0.977 to 1.028
|
0.996 L
Interval 0.968 to 1.024
|
|
Change From Baseline in Lung Lobar Volumes Measured at FRC and TLC Scan Conditions, Presented in Longitudinal Scan Types, Measured in 5 Lobes and 5 Regions at Day 12 and Day 28
TLC Upper Day 12, n =58, 59
|
1.005 L
Interval 0.993 to 1.017
|
0.997 L
Interval 0.985 to 1.01
|
|
Change From Baseline in Lung Lobar Volumes Measured at FRC and TLC Scan Conditions, Presented in Longitudinal Scan Types, Measured in 5 Lobes and 5 Regions at Day 12 and Day 28
TLC UpperDay 28, n =56, 59
|
1.004 L
Interval 0.984 to 1.023
|
0.999 L
Interval 0.985 to 1.012
|
|
Change From Baseline in Lung Lobar Volumes Measured at FRC and TLC Scan Conditions, Presented in Longitudinal Scan Types, Measured in 5 Lobes and 5 Regions at Day 12 and Day 28
TLC Lower Day 12, n =58, 59
|
1.009 L
Interval 0.982 to 1.037
|
0.997 L
Interval 0.972 to 1.023
|
|
Change From Baseline in Lung Lobar Volumes Measured at FRC and TLC Scan Conditions, Presented in Longitudinal Scan Types, Measured in 5 Lobes and 5 Regions at Day 12 and Day 28
TLC Lower Day 28, n =56, 59
|
1.000 L
Interval 0.978 to 1.024
|
1.003 L
Interval 0.973 to 1.034
|
|
Change From Baseline in Lung Lobar Volumes Measured at FRC and TLC Scan Conditions, Presented in Longitudinal Scan Types, Measured in 5 Lobes and 5 Regions at Day 12 and Day 28
TLC Total Day 12, n =58, 59
|
1.005 L
Interval 0.989 to 1.022
|
0.997 L
Interval 0.98 to 1.015
|
|
Change From Baseline in Lung Lobar Volumes Measured at FRC and TLC Scan Conditions, Presented in Longitudinal Scan Types, Measured in 5 Lobes and 5 Regions at Day 12 and Day 28
TLC Total Day 28, n =56, 59
|
1.002 L
Interval 0.982 to 1.022
|
1.001 L
Interval 0.981 to 1.021
|
SECONDARY outcome
Timeframe: Baseline, Day 12 and Day 28Population: ITT Population excluding the subject with a pacemaker.
Imaging trachea length and diameter was derived from HRCT to evaluate the effect of once daily inhaled dose of GSK2269557 on lung parameters. TLC is the volume in the lungs at maximal inflation and FRC is the volume in the lungs at the end-expiratory position. The Baseline for the assessment on Day 12 and Day 28 is the Screening value. Change from Baseline is the post-Baseline value minus the Baseline value. The change from Baseline data is presented for Day 12 and Day 28 for trachea length and diameter. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Outcome measures
| Measure |
Placebo
n=62 Participants
Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
GSK2269557 1000 mcg
n=63 Participants
Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
|---|---|---|
|
Change From Baseline in Imaging Trachea Length and Diameter After 12 Days of Treatment and After 28 Days of Treatment
FRC Length Day 12, n=56, 59
|
-1.886 Millimeter (mm)
Standard Deviation 7.6043
|
0.517 Millimeter (mm)
Standard Deviation 6.0882
|
|
Change From Baseline in Imaging Trachea Length and Diameter After 12 Days of Treatment and After 28 Days of Treatment
FRC Length Day 28, n=56, 58
|
-1.434 Millimeter (mm)
Standard Deviation 6.7887
|
0.485 Millimeter (mm)
Standard Deviation 6.6552
|
|
Change From Baseline in Imaging Trachea Length and Diameter After 12 Days of Treatment and After 28 Days of Treatment
FRC Diameter Day 12, n=56, 59
|
-0.247 Millimeter (mm)
Standard Deviation 1.8777
|
0.059 Millimeter (mm)
Standard Deviation 1.1657
|
|
Change From Baseline in Imaging Trachea Length and Diameter After 12 Days of Treatment and After 28 Days of Treatment
FRC Diameter Day 28, n=56, 58
|
-0.261 Millimeter (mm)
Standard Deviation 1.8672
|
-0.047 Millimeter (mm)
Standard Deviation 1.1522
|
|
Change From Baseline in Imaging Trachea Length and Diameter After 12 Days of Treatment and After 28 Days of Treatment
TLC Length Day 12, n=58, 59
|
0.295 Millimeter (mm)
Standard Deviation 4.0608
|
-0.663 Millimeter (mm)
Standard Deviation 3.8027
|
|
Change From Baseline in Imaging Trachea Length and Diameter After 12 Days of Treatment and After 28 Days of Treatment
TLC Length Day 28, n=56, 59
|
0.168 Millimeter (mm)
Standard Deviation 4.5501
|
-0.495 Millimeter (mm)
Standard Deviation 3.7295
|
|
Change From Baseline in Imaging Trachea Length and Diameter After 12 Days of Treatment and After 28 Days of Treatment
TLC Diameter Day 12, n=58, 59
|
-0.067 Millimeter (mm)
Standard Deviation 1.0127
|
-0.056 Millimeter (mm)
Standard Deviation 0.5098
|
|
Change From Baseline in Imaging Trachea Length and Diameter After 12 Days of Treatment and After 28 Days of Treatment
TLC Diameter Day 28, n=56, 59
|
-0.046 Millimeter (mm)
Standard Deviation 1.0240
|
-0.082 Millimeter (mm)
Standard Deviation 0.5579
|
SECONDARY outcome
Timeframe: Baseline, Day 12 and Day 28Population: ITT Population excluding the subject with a pacemaker.
Imaging trachea length/diameter was derived from HRCT to evaluate the effect of once daily inhaled dose of GSK2269557 on lung parameters. TLC is the volume in the lungs at maximal inflation and FRC is the volume in the lungs at the end-expiratory position. The Baseline for the assessment on Day 12 and Day 28 is the Screening value. Change from Baseline is the post-Baseline value minus the Baseline value. The change from Baseline data is presented for Day 12 and Day 28 for trachea length/diameter. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Outcome measures
| Measure |
Placebo
n=62 Participants
Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
GSK2269557 1000 mcg
n=63 Participants
Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
|---|---|---|
|
Change From Baseline in Imaging Trachea Length/Diameter After 12 Days of Treatment and After 28 Days of Treatment
FRC Length/Diameter Day 12, n=56
|
-0.030 ratio
Standard Deviation 0.7717
|
0.000 ratio
Standard Deviation 0.5620
|
|
Change From Baseline in Imaging Trachea Length/Diameter After 12 Days of Treatment and After 28 Days of Treatment
FRC Length/Diameter Day 28, n=56
|
-0.017 ratio
Standard Deviation 0.7469
|
0.059 ratio
Standard Deviation 0.5169
|
|
Change From Baseline in Imaging Trachea Length/Diameter After 12 Days of Treatment and After 28 Days of Treatment
TLC Length/Diameter Day 12, n=5
|
0.024 ratio
Standard Deviation 0.3602
|
-0.023 ratio
Standard Deviation 0.2913
|
|
Change From Baseline in Imaging Trachea Length/Diameter After 12 Days of Treatment and After 28 Days of Treatment
TLC Length/Diameter Day 28, n=5
|
0.004 ratio
Standard Deviation 0.3715
|
-0.006 ratio
Standard Deviation 0.2783
|
SECONDARY outcome
Timeframe: From start of IP through the Study Phase (84 days post-dose) (assessed up to follow-up duration of approximately 100 days)Population: All Subjects Population: all randomized participants who received at least one dose of study treatment.
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were collected from the start of study treatment until the follow-up contact.
Outcome measures
| Measure |
Placebo
n=63 Participants
Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
GSK2269557 1000 mcg
n=63 Participants
Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
|---|---|---|
|
Number of Participants With Adverse Events (AE)
|
41 Participants
|
49 Participants
|
SECONDARY outcome
Timeframe: Day 1, Day 12, Day 28, Day 56, Day 84 and at follow-up (approximately 100 Days)Population: All Subjects Population
Hematology parameter included Hematocrit (HCT), Hemoglobin (HB), Lymphocytes (LC), Platelet Count (PC), Total Neutrophils (TN), and White Blood Cell (WBC) count at the indicated timepoints: Day 1, Day 12, Day 28, Day 56, Day 84, and at follow-up/Early withdrawal. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Outcome measures
| Measure |
Placebo
n=63 Participants
Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
GSK2269557 1000 mcg
n=63 Participants
Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
|---|---|---|
|
Number of Participants With Abnormal Hematology Parameters
High HCT Screening/Day 1, n=63, 62
|
4 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
High HCT Day 12, n=60, 58
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
High HCT Day 28, n=57, 58
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
High HCT Day 56, n=55, 52
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
High HCT Day 84, n=49, 53
|
2 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
High HCT Follow-up/Early Withdraw, n=54, 53
|
4 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
High HB Screening/ Day 1, n=63, 63
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
High HB Day 12, n=60, 58
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
High HB Day 28, n=57, 58
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
High HB Day 56, n=55, 52
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
High HB Day 84, n=49, 53
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
High HB Follow-up/Early Withdraw, n=54, 53
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
Low LC Screening/ Day 1, n=62, 60
|
9 Participants
|
7 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
Low LC Day 12, n=59, 58
|
2 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
Low LC Day 28, n=56, 57
|
3 Participants
|
3 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
Low LC Day 56, n=54, 52
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
Low LC Day 84, n=48, 50
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
Low LC Follow-up/Early Withdraw, n=53, 53
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
High PC Screening/Day 1, n=63, 63
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
High PC Day 12, n=58, 57
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
High PC Day 28, n=57, 58
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
High PC Day 56, n=55, 52
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
High PC Day 84, n=49, 53
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
High PC Follow-up/Early Withdraw, n=54, 53
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
Low PC Screening/ Day 1, n=63, 63
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
Low PC Day 12, n=58, 57
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
Low PC Day 28, n=57, 58
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
Low PC Day 56, n=55, 52
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
Low PC Day 84, n=49, 53
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
Low PC Follow-up/Early Withdraw, n=54, 53
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
Low TN Screening/ Day 1, n=62, 60
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
Low TN Day 12, n=59, 58
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
Low TN Day 28, n=56, 57
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
Low TN Day 56, n=54, 52
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
Low TN Day 84, n=48, 50
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
Low TN Follow-up/Early Withdraw, n=53, 53
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
High WBC Screening/ Day 1, n=63, 63
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
High WBC Day 12, n=56, 56
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
High WBC Day 28, n=56, 57
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
High WBC Day 56, n=54, 52
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
High WBC Day 84, n=48, 50
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
High WBC Follow-up/Early Withdraw, n=53, 53
|
0 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
Low WBC Screening/ Day 1, n=63, 63
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
Low WBC Day 12, n=56, 56
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
Low WBC Day 28, n=56, 57
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
Low WBC Day 56, n=54, 52
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
Low WBC Day 84, n=48, 50
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hematology Parameters
Low WBC Follow-up/Early Withdraw, n=53, 53
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1, Day 12, Day 28, Day 56, Day 84 and at follow-up (approximately 100 days)Population: All Subject Population
Clinical Chemistry parameters included Alanine Amino Transferase (ALT), Albumin, Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Calcium (Ca), Glucose, Potassium (K), Sodium (Na), and Total Bilirubin (TBL) at the indicated timepoints: Day 1, Day 12, Day 28, Day 56, Day 84, and at follow-up/Early withdrawal. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Outcome measures
| Measure |
Placebo
n=63 Participants
Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
GSK2269557 1000 mcg
n=63 Participants
Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
|---|---|---|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High ALT Screening/ Day 1, n=63, 63
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High ALT Day 12, n=61, 60
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High ALT Day 28, n=58, 60
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High ALT Day 56, n=55, 56
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High ALT Day 84, n=52, 55
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High ALT Follow-up/Early Withdraw, n=53, 54
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
Low Albumin Screening/ Day 1, n=63, 63
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
Low Albumin Day 12, n=61, 60
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
Low Albumin Day 28, n=58, 60
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
Low Albumin Day 56, n=55, 56
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
Low Albumin Day 84, n=52, 55
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
Low Albumin Follow-up/Early Withdraw, n=53, 53
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High ALP Screening/ Day 1, n=63, 63
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High ALP Day 12, n=61, 60
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High ALP Day 28, n=58, 60
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High ALP Day 56, n=55, 56
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High ALP Day 84, n=52, 55
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High ALP Follow-up/Early Withdraw, n=53, 54
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High AST Screening/ Day 1, n=63, 63
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High AST Day 12, n=61, 60
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High AST Day 28, n=58, 60
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High AST Day 56, n=55, 56
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High AST Day 84, n=52, 55
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High AST Follow-up/Early Withdraw, n=53, 54
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High Ca Screening/ Day 1, n=63, 63
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High Ca Day 12, n=61, 60
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High Ca Day 28, n=58, 60
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High Ca Day 56, n=55, 56
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High Ca Day 84, n=52, 55
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High Ca Follow-up/Early Withdraw, n=53, 53
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
Low Ca Screening/ Day 1, n=63, 63
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
Low Ca Day 12, n=61, 60
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
Low Ca Day 28, n=58, 60
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
Low Ca Day 56, n=55, 56
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
Low Ca Day 84, n=52, 55
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
Low Ca Follow-up/Early Withdraw, n=53, 53
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High Glucose Screening/ Day 1, n=63, 63
|
6 Participants
|
8 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High Glucose Day 12, n=61, 60
|
2 Participants
|
6 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High Glucose Day 28, n=58, 60
|
1 Participants
|
3 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High Glucose Day 56, n=55, 56
|
3 Participants
|
5 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High Glucose Day 84, n=52, 55
|
5 Participants
|
3 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High Glucose Follow-up/Early Withdraw, n=53, 53
|
4 Participants
|
6 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
Low Glucose Screening/ Day 1, n=63, 63
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
Low Glucose Day 12, n=61, 60
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
Low Glucose Day 28, n=58, 60
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
Low Glucose Day 56, n=55, 56
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
Low Glucose Day 84, n=52, 55
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
Low Glucose Follow-up/Early Withdraw, n=53, 53
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High Potassium Screening/ Day 1, n=63, 63
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High Potassium Day 12, n=61, 60
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High Potassium Day 28, n=58, 60
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High Potassium Day 56, n=55, 56
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High Potassium Day 84, n=52, 550
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High Potassium Follow-up/Early Withdraw, n=53, 53
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
Low Potassium Screening/ Day 1, n=63, 63
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
Low Potassium Day 12, n=61, 60
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
Low Potassium V4 Day 28, n=58, 60
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
Low Potassium Day 56, n=55, 56
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
Low Potassium Day 84, n=52, 55
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
Low Potassium Follow-up/Early Withdraw, n=53, 53
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High Sodium Screening/ Day 1, n=63, 63
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High Sodium Day 12, n=61, 60
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High Sodium Day 28, n=58, 60
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High Sodium Day 56, n=55, 56
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High Sodium Day 84, n=52, 55
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High Sodium Follow-up/Early Withdraw, n=53, 53
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
Low Sodium Screening/ Day 1, n=63, 63
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
Low Sodium Day 12, n=61, 60
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
Low Sodium Day 28, n=58, 60
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
Low Sodium Day 56, n=55, 56
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
Low Sodium Day 84, n=52, 55
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
Low Sodium Follow-up/Early Withdraw, n=53, 53
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High TBL Screening/ Day 1, n=63, 63
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High TBL Day 12, n=61, 60
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High TBL Day 28, n=58,60
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High TBL Day 56, n=55, 56
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High TBL Day 84, n=51, 55
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Chemistry Parameters
High TBL Follow-up/Early Withdraw, n=53, 54
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1, Day 12, Day 28, Day 56, Day 84 and at follow-up (approximately 100 days)Population: All Subject Population
Vital signs included high and low diastolic and systolic blood presure (BP), and high and low heart rate (HR). Vital signs outside the range of potential clinical importance are presented at the indicated timepoints: Day 1, Day 12, Day 28, Day 56, Day 84, follow-up/Early withdrawal and at any visit post-baseline . Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Outcome measures
| Measure |
Placebo
n=63 Participants
Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
GSK2269557 1000 mcg
n=63 Participants
Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
|---|---|---|
|
Number of Participants With Abnormal Vital Signs
High DBP Screening/Day 1, n=63, 63
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
High DBP Day 12, n=61, 60
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
High DBP Day 28, n=58, 60
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
High DBP Day 56, n=55, 56
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
High DBP Day 84, n=52, 55
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
High DBP Follow-up/Early Withdraw, n=55, 60
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
High DBP Any Visit Post Baseline, n=62, 62
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
Low DBP Screening/ Day 1, n=63, 63
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
Low DBP Day 12, n=61, 60
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
Low DBP Day 28, n=58, 60
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
Low DBP Day 56, n=55, 56
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
Low DBP V6 Day 84, n=52, 55
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
Low DBP Follow-up/Early Withdraw, n=55, 60
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
Low DBP Any Visit Post Baseline, n=62, 62
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
High SBP Screening/ Day 1, n=63, 63
|
2 Participants
|
3 Participants
|
|
Number of Participants With Abnormal Vital Signs
High SBP Day 12, n=61, 60
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Vital Signs
High SBP Day 28, n=58, 60
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
High SBP Day 56, n=55, 56
|
2 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Vital Signs
High SBP Day 84, n=52, 55
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Vital Signs
High SBP Follow-up/Early Withdraw, n=55, 60
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Vital Signs
High SBP Any Visit Post Baseline, n=62, 62
|
3 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Vital Signs
Low SBP Screening/ V1 Day 1, n=63, 63
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
Low SBP Day 12, n=61, 60
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
Low SBP Day 28, n=58, 60
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
Low SBP Day 56, n=55, 56
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
Low SBP Day 84, n=52, 55
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
Low SBP Follow-up/Early Withdraw, n=55, 60
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
Low SBP Any Visit Post Baseline, n=62, 62
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
High HR Screening/ Day 1, n=63, 63
|
0 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Vital Signs
High HR Day 12, n=61, 60
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
High HR Day 28, n=58, 60
|
2 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Vital Signs
High HR Day 56, n=55, 56
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Vital Signs
High HR Day 84, n=52, 55
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Vital Signs
High HR Follow-up/Early Withdraw, n=55, 60
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Vital Signs
High HR Any Visit Post Baseline, n=62, 62
|
2 Participants
|
3 Participants
|
|
Number of Participants With Abnormal Vital Signs
Low HR Screening/ Day 1, n=63, 63
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
Low HR Day 12, n=61, 60
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
Low HR Day 28, n=58, 60
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
Low HR Day 56, n=55, 56
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
Low HR Day 84, n=52, 55
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
Low HR Follow-up/Early Withdraw, n=55, 60
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
Low HR Any Visit Post Baseline, n=62, 62
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1, Day 12, Day 28, Day 56, Day 84 and at follow-up (approximately 100 days)Population: All Subject Population
12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT interval corrected using the Fridericia's formula (QTcF). Clinically non-significant (CN) and Clinically significant (CS) abnormal ECG measurements are presented for Day 1, Day 12, Day 28, Day 56, Day 84, follow-up/Early withdrawal and at any visit post-baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Outcome measures
| Measure |
Placebo
n=63 Participants
Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
GSK2269557 1000 mcg
n=63 Participants
Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
|---|---|---|
|
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG)
CN ECG Screening/ Day 1, n=63, 63
|
45 Participants
|
40 Participants
|
|
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG)
CS ECG Screening/ Day 1, n=63, 63
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG)
CN ECG Day 12, n=61, 60
|
43 Participants
|
40 Participants
|
|
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG)
CS ECG Day 12, n=61, 60
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG)
CN ECG Day 28, n=58, 60
|
41 Participants
|
40 Participants
|
|
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG)
CS ECG Day 28, n=58, 60
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG)
CN ECG Day 56, n=55, 56
|
36 Participants
|
39 Participants
|
|
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG)
CS ECG Day 56, n=55, 56
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG)
CN ECG Day 84, n=52, 55
|
36 Participants
|
38 Participants
|
|
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG)
CS ECG Day 84, n=52, 55
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG)
CN ECG Follow-up/Early Withdraw, n=56, 60
|
35 Participants
|
43 Participants
|
|
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG)
CS ECG Follow-up/Early Withdraw, n=56, 60
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG)
CN ECG Any Visit Post Baseline, n=63, 62
|
51 Participants
|
51 Participants
|
|
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG)
CS ECG Any Visit Post Baseline, n=63, 62
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Pre-dose, 5 min, 3 hrs and 24 hrsPopulation: Pharmacokinetic (PK) Population
Plasma samples were collected at pre-dose, 5 minutes (min), 3 hrs, and 24 hrs post-dose on Day 1. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Pharmacokinetic (PK) Population: all participants in the Safety Population for whom a PK sample was obtained and analyzed. Safety Population comprises of all participants who were randomized.
Outcome measures
| Measure |
Placebo
n=62 Participants
Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
GSK2269557 1000 mcg
Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
|---|---|---|
|
Day 1 Plasma Concentration up to 24 Hours (Hrs) Post-dose
Pre-dose, n=61
|
33.0 pg/mL
Standard Deviation NA
Only 5 of the 61 values had not been imputed as zero; therefore, calculation of the SD would result in a potentially misleading value and hence is omitted from the data display (if \>30% of values are imputed then the SD will not be included).
|
—
|
|
Day 1 Plasma Concentration up to 24 Hours (Hrs) Post-dose
5 min, n=60
|
476.6 pg/mL
Standard Deviation 520.85
|
—
|
|
Day 1 Plasma Concentration up to 24 Hours (Hrs) Post-dose
3 hrs, n=61
|
553.7 pg/mL
Standard Deviation 326.98
|
—
|
|
Day 1 Plasma Concentration up to 24 Hours (Hrs) Post-dose
24 hrs, n=20
|
539.0 pg/mL
Standard Deviation 482.76
|
—
|
SECONDARY outcome
Timeframe: Pre-dose Day 12, Day 28, Day 56, and Day 84Population: PK Population
Trough concentrations are presented for Pre-dose Day 12, Pre-dose Day 28, Pre-dose Day 56, and Pre-dose Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Outcome measures
| Measure |
Placebo
n=62 Participants
Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
GSK2269557 1000 mcg
Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
|---|---|---|
|
Trough Concentration After 12 Days, 28 Days, 56 Days and 84 Days of Treatment
Pre-dose Day 12, n=57
|
1001.8 pg/mL
Standard Deviation 669.05
|
—
|
|
Trough Concentration After 12 Days, 28 Days, 56 Days and 84 Days of Treatment
Pre-dose Day 28, n=60
|
1028.8 pg/mL
Standard Deviation 798.38
|
—
|
|
Trough Concentration After 12 Days, 28 Days, 56 Days and 84 Days of Treatment
Pre-dose Day 56, n=55
|
1119.8 pg/mL
Standard Deviation 1389.53
|
—
|
|
Trough Concentration After 12 Days, 28 Days, 56 Days and 84 Days of Treatment
Pre-dose Day 84, n=54
|
948.6 pg/mL
Standard Deviation 1078.31
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 28, and Day 84Population: ITT Population
FEV1 is the volume of air that can forcibly be blown out in one second. A triplicate FEV1 measurement were taken daily in the morning before dose administration. Baseline is defined as the assessment on Day 1 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84.Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Outcome measures
| Measure |
Placebo
n=63 Participants
Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
GSK2269557 1000 mcg
n=63 Participants
Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
|---|---|---|
|
Changes From Baseline in Forced Expiratory Volume in One Second (FEV1) Measured Daily
Day 28, n=55, 58
|
-70.4 mL
Standard Deviation 43.07
|
-72.2 mL
Standard Deviation 41.28
|
|
Changes From Baseline in Forced Expiratory Volume in One Second (FEV1) Measured Daily
Day 84, n=46, 54
|
-83.3 mL
Standard Deviation 49.73
|
-22.7 mL
Standard Deviation 46.77
|
SECONDARY outcome
Timeframe: Baseline, Day 28, and Day 84Population: ITT Population
PEF is the maximal flow (or speed) achieved during the maximally forced expiration initiated at full inspiration. Baseline is defined as the assessment on Day 1 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84.Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Outcome measures
| Measure |
Placebo
n=63 Participants
Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
GSK2269557 1000 mcg
n=63 Participants
Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
|---|---|---|
|
Changes From Baseline in Peak Expiratory Flow (PEF) Measured Daily
Day 28, n=54, 57
|
-13.12 L/min
Standard Deviation 60.421
|
-4.76 L/min
Standard Deviation 57.578
|
|
Changes From Baseline in Peak Expiratory Flow (PEF) Measured Daily
Day 84, n=45, 53
|
-0.52 L/min
Standard Deviation 65.374
|
-0.85 L/min
Standard Deviation 71.170
|
SECONDARY outcome
Timeframe: Baseline, Day 28 and Day 84Population: ITT Population
DLco is diffusing capacity o f the lungs for carbon monoxide and is defined as the extent to which oxygen passes from the air sacs of the lungs into the blood. KCO is the carbon monoxide transfer coefficient. It is an index of the efficiency of alveolar transfer of carbon monoxide. Baseline is defined as the assessment on Day 2 and percent change from Baseline is the post-Baseline value minus Baseline value/100. Change from Baseline data is presented for Day 28 and Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Outcome measures
| Measure |
Placebo
n=63 Participants
Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
GSK2269557 1000 mcg
n=63 Participants
Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
|---|---|---|
|
Percent Change From Baseline in Diffusion Capacity (DLco, Kco) After 28 Days and After 84 Days of Treatment
DLco Day 28, n=53, 56
|
-2.783 Percent
Standard Deviation 9.3950
|
-0.687 Percent
Standard Deviation 8.2655
|
|
Percent Change From Baseline in Diffusion Capacity (DLco, Kco) After 28 Days and After 84 Days of Treatment
DLco Day 84, n=45, 51
|
-2.385 Percent
Standard Deviation 9.6016
|
0.560 Percent
Standard Deviation 9.5434
|
|
Percent Change From Baseline in Diffusion Capacity (DLco, Kco) After 28 Days and After 84 Days of Treatment
Kco Day 28, n=53, 55
|
-2.745 Percent
Standard Deviation 9.7851
|
-0.875 Percent
Standard Deviation 8.0041
|
|
Percent Change From Baseline in Diffusion Capacity (DLco, Kco) After 28 Days and After 84 Days of Treatment
Kco Day 84, n=45, 50
|
-2.367 Percent
Standard Deviation 10.2835
|
-0.759 Percent
Standard Deviation 8.7801
|
SECONDARY outcome
Timeframe: Baseline, Day 28 and Day 84Population: ITT Population
TLC is the maximum amount of air that can fill the lungs. Baseline is defined as the assessment on Day 2 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Note: values mentioned as 95% confidence interval below are in fact values of 95% credible interval.
Outcome measures
| Measure |
Placebo
n=63 Participants
Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
GSK2269557 1000 mcg
n=63 Participants
Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
|---|---|---|
|
Change From Baseline in Total Lung Capacity (TLC) After 28 Days and After 84 Days of Treatment
Day 28, n=53, 59
|
-0.010 L
Interval -0.211 to 0.19
|
-0.155 L
Interval -0.344 to 0.035
|
|
Change From Baseline in Total Lung Capacity (TLC) After 28 Days and After 84 Days of Treatment
Day 84, n=47, 55
|
-0.149 L
Interval -0.462 to 0.163
|
-0.029 L
Interval -0.32 to 0.265
|
SECONDARY outcome
Timeframe: Baseline, Day 28 and Day 84Population: ITT Population
Residual volume is a lung volume representing the amount of air left in the lungs after a forced exhalation. Baseline is defined as the assessment on Day 2 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Note: values mentioned as 95% confidence interval below are in fact values of 95% credible interval.
Outcome measures
| Measure |
Placebo
n=63 Participants
Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
GSK2269557 1000 mcg
n=63 Participants
Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
|---|---|---|
|
Change From Baseline in Residual Volume After 28 Days and After 84 Days of Treatment
Day 28, n=53, 59
|
-0.157 L
Interval -0.441 to 0.129
|
0.022 L
Interval -0.249 to 0.292
|
|
Change From Baseline in Residual Volume After 28 Days and After 84 Days of Treatment
Day 84, =47, 54
|
-0.113 L
Interval -0.43 to 0.206
|
0.001 L
Interval -0.299 to 0.296
|
SECONDARY outcome
Timeframe: Baseline, Day 28 and Day 84Population: ITT Population
Functional residual capacity is the volume of air present in the lungs at the end of passive expiration. Baseline is defined as the assessment on Day 2 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Outcome measures
| Measure |
Placebo
n=63 Participants
Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
GSK2269557 1000 mcg
n=63 Participants
Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
|---|---|---|
|
Change From Baseline in Functional Residual Capacity After 28 Days and After 84 Days of Treatment
Day 28, n=52, 59
|
0.0010 L
Standard Deviation 0.86637
|
-0.0919 L
Standard Deviation 0.92501
|
|
Change From Baseline in Functional Residual Capacity After 28 Days and After 84 Days of Treatment
Day 84, =46, 55
|
-0.2219 L
Standard Deviation 1.06874
|
-0.0505 L
Standard Deviation 1.41910
|
SECONDARY outcome
Timeframe: Baseline, Day 28 and Day 84Population: ITT Population
sRaw is the measure of specific resistance. Baseline is defined as the assessment on Day 2 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Outcome measures
| Measure |
Placebo
n=63 Participants
Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
GSK2269557 1000 mcg
n=63 Participants
Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
|---|---|---|
|
Change From Baseline in Specific Resistance (sRaw) After 28 Days and After 84 Days of Treatment
Day 28, n= 17, 17
|
0.9734 KPa*s
Standard Deviation 0.45833
|
0.8372 KPa*s
Standard Deviation 0.49176
|
|
Change From Baseline in Specific Resistance (sRaw) After 28 Days and After 84 Days of Treatment
Day 84, n=11, 13
|
0.9949 KPa*s
Standard Deviation 0.24484
|
0.8495 KPa*s
Standard Deviation 0.39565
|
SECONDARY outcome
Timeframe: Baseline, Day 28 and Day 84Population: ITT Population
Baseline is defined as the assessment on Day 2 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).Note: values mentioned as 95% confidence interval below are in fact values of 95% Credible Interval.
Outcome measures
| Measure |
Placebo
n=63 Participants
Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
GSK2269557 1000 mcg
n=63 Participants
Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
|---|---|---|
|
Change From Baseline in Specific Conductance (sGaw) After 28 Days and After 84 Days of Treatment
Day 28, n=47, 52
|
0.875 1/KPA*S
Interval 0.773 to 0.99
|
1.024 1/KPA*S
Interval 0.91 to 1.15
|
|
Change From Baseline in Specific Conductance (sGaw) After 28 Days and After 84 Days of Treatment
Day 84, =40, 47
|
0.965 1/KPA*S
Interval 0.86 to 1.083
|
1.075 1/KPA*S
Interval 0.967 to 1.197
|
SECONDARY outcome
Timeframe: Baseline, Day 28 and Day 84Population: ITT Population
The chronic obstructive pulmonary disease (COPD) assessement test (CAT) and Modified Medical Research Council (MMRC) Dyspnea Scale were completed at the indicated timepoints: Baseline, Day 28 and Day 84. CAT and MMRC scales are prestned as: 1.I never cough/I cough all the time 2.I have no phelgm in my chest at all/My chest is completely full of phelgm 3. My chest does not feel tight at all/My chest feels very tight 4.Walk up hilll or stairs not breathless/Walk up hill or stairs very breathless 5. Not limited doing any home activities/Very limited doing any home activities 6. Confident leaving home/No confident leaving home 7. I sleep soundly/I don't sleep soundly because of my lung condition and 8. I have lots of energy/I have no energy at all. Baseline is defined as the assessment on Day 1. Score 0 indicates not troubled with breathlessness to 4:too breathless. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Outcome measures
| Measure |
Placebo
n=63 Participants
Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
GSK2269557 1000 mcg
n=63 Participants
Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
|---|---|---|
|
Questionnaires CAT and MMRC Scale at Baseline, Day 28 and Day 84
never cough/cough all the time D28, n=58, 60
|
-0.4 Scores on a scale
Standard Deviation 1.16
|
-0.7 Scores on a scale
Standard Deviation 1.14
|
|
Questionnaires CAT and MMRC Scale at Baseline, Day 28 and Day 84
never cough/cough all the time D84, n=53, 55
|
-0.6 Scores on a scale
Standard Deviation 1.48
|
-0.7 Scores on a scale
Standard Deviation 0.99
|
|
Questionnaires CAT and MMRC Scale at Baseline, Day 28 and Day 84
No phlegm/full of phlegm in chest D28, n=58, 60
|
-0.6 Scores on a scale
Standard Deviation 1.26
|
-0.3 Scores on a scale
Standard Deviation 1.24
|
|
Questionnaires CAT and MMRC Scale at Baseline, Day 28 and Day 84
No phlegm/full of phlegm in chest D84, n=53, 55
|
-0.8 Scores on a scale
Standard Deviation 1.20
|
-0.6 Scores on a scale
Standard Deviation 1.18
|
|
Questionnaires CAT and MMRC Scale at Baseline, Day 28 and Day 84
No tightness/very tight chest D28, n=58, 60
|
-0.2 Scores on a scale
Standard Deviation 1.30
|
-0.3 Scores on a scale
Standard Deviation 1.16
|
|
Questionnaires CAT and MMRC Scale at Baseline, Day 28 and Day 84
No tightness/very tight chest D84, n=53, 55
|
-0.1 Scores on a scale
Standard Deviation 1.43
|
-0.3 Scores on a scale
Standard Deviation 1.34
|
|
Questionnaires CAT and MMRC Scale at Baseline, Day 28 and Day 84
Hill/stairs nobreathless/breathlessD28, n=58, 60
|
-0.5 Scores on a scale
Standard Deviation 0.98
|
-0.5 Scores on a scale
Standard Deviation 1.08
|
|
Questionnaires CAT and MMRC Scale at Baseline, Day 28 and Day 84
Hill/stairs nobreathless/breathless D84, n=53, 55
|
-0.4 Scores on a scale
Standard Deviation 1.43
|
-0.3 Scores on a scale
Standard Deviation 1.03
|
|
Questionnaires CAT and MMRC Scale at Baseline, Day 28 and Day 84
Unlimited/limited home activity D28, n=58, 60
|
-0.3 Scores on a scale
Standard Deviation 1.43
|
-0.3 Scores on a scale
Standard Deviation 1.15
|
|
Questionnaires CAT and MMRC Scale at Baseline, Day 28 and Day 84
Unlimited/limited home activity D84, n=53, 55
|
-0.3 Scores on a scale
Standard Deviation 1.24
|
-0.1 Scores on a scale
Standard Deviation 1.39
|
|
Questionnaires CAT and MMRC Scale at Baseline, Day 28 and Day 84
Confident/not confident leave home D28, n=58, 60
|
-0.4 Scores on a scale
Standard Deviation 1.24
|
-0.1 Scores on a scale
Standard Deviation 1.27
|
|
Questionnaires CAT and MMRC Scale at Baseline, Day 28 and Day 84
Confident/not confident leave homeD84, n=53, 55
|
-0.2 Scores on a scale
Standard Deviation 1.49
|
-0.3 Scores on a scale
Standard Deviation 1.34
|
|
Questionnaires CAT and MMRC Scale at Baseline, Day 28 and Day 84
Sound sleep/No sound sleep D28, n=58, 60
|
-0.4 Scores on a scale
Standard Deviation 1.11
|
-0.2 Scores on a scale
Standard Deviation 1.30
|
|
Questionnaires CAT and MMRC Scale at Baseline, Day 28 and Day 84
Sound sleep/No sound sleep D84, n=53, 55
|
-0.3 Scores on a scale
Standard Deviation 1.60
|
-0.3 Scores on a scale
Standard Deviation 1.36
|
|
Questionnaires CAT and MMRC Scale at Baseline, Day 28 and Day 84
Lot of energy/no energy D28, n=58, 60
|
-0.1 Scores on a scale
Standard Deviation 1.46
|
-0.3 Scores on a scale
Standard Deviation 1.22
|
|
Questionnaires CAT and MMRC Scale at Baseline, Day 28 and Day 84
Lot of energy/no energy D84, n=53, 55
|
-0.2 Scores on a scale
Standard Deviation 1.49
|
-0.3 Scores on a scale
Standard Deviation 1.25
|
|
Questionnaires CAT and MMRC Scale at Baseline, Day 28 and Day 84
CAT Total Score D28, n=58, 60
|
-2.9 Scores on a scale
Standard Deviation 6.05
|
-2.6 Scores on a scale
Standard Deviation 5.13
|
|
Questionnaires CAT and MMRC Scale at Baseline, Day 28 and Day 84
CAT Total Score D84, n=53, 55
|
-3.0 Scores on a scale
Standard Deviation 7.16
|
-3.1 Scores on a scale
Standard Deviation 5.45
|
|
Questionnaires CAT and MMRC Scale at Baseline, Day 28 and Day 84
MMRC Dyspnoea Score D28, n=58, 60
|
-0.4 Scores on a scale
Standard Deviation 0.75
|
-0.2 Scores on a scale
Standard Deviation 0.72
|
|
Questionnaires CAT and MMRC Scale at Baseline, Day 28 and Day 84
MMRC Dyspnoea Score D84, n=53, 55
|
-0.4 Scores on a scale
Standard Deviation 0.95
|
-0.3 Scores on a scale
Standard Deviation 0.71
|
SECONDARY outcome
Timeframe: 13 weeksPopulation: ITT Population
Treatment failure types are presented as: recurrent exacerbations, prolonged treatment of current exacerbation (beyond 14 days), additional treatment with systemic / oral corticosteroids and / or antibiotics, and requirement for invasive mechanical ventilation.
Outcome measures
| Measure |
Placebo
n=63 Participants
Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
GSK2269557 1000 mcg
n=63 Participants
Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
|---|---|---|
|
Number of Participants With Treatment Failures
Recurrent exacerbation
|
17 Participants
|
13 Participants
|
|
Number of Participants With Treatment Failures
Prolonged Treatment of current exacerbation
|
9 Participants
|
7 Participants
|
|
Number of Participants With Treatment Failures
continuation of treatment with SOC/antibiotics
|
4 Participants
|
3 Participants
|
|
Number of Participants With Treatment Failures
Additional treatment with SOC/antibiotics
|
6 Participants
|
6 Participants
|
|
Number of Participants With Treatment Failures
Requirement of invasive mechanical ventilation
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo
GSK2269557 1000 mcg
Serious adverse events
| Measure |
Placebo
n=63 participants at risk
Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
GSK2269557 1000 mcg
n=63 participants at risk
Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
|---|---|---|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/63 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication up to approximately 100 days.
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
1.6%
1/63 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication up to approximately 100 days.
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Gastrointestinal disorders
Constipation
|
1.6%
1/63 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication up to approximately 100 days.
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
0.00%
0/63 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication up to approximately 100 days.
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
General disorders
Malaise
|
1.6%
1/63 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication up to approximately 100 days.
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
0.00%
0/63 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication up to approximately 100 days.
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Infections and infestations
Lower respiratory tract infection
|
1.6%
1/63 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication up to approximately 100 days.
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
0.00%
0/63 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication up to approximately 100 days.
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/63 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication up to approximately 100 days.
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
1.6%
1/63 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication up to approximately 100 days.
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/63 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication up to approximately 100 days.
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
1.6%
1/63 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication up to approximately 100 days.
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/63 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication up to approximately 100 days.
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
1.6%
1/63 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication up to approximately 100 days.
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Psychiatric disorders
Anxiety
|
1.6%
1/63 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication up to approximately 100 days.
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
0.00%
0/63 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication up to approximately 100 days.
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Psychiatric disorders
Suicide attempt
|
1.6%
1/63 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication up to approximately 100 days.
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
0.00%
0/63 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication up to approximately 100 days.
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
14.3%
9/63 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication up to approximately 100 days.
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
6.3%
4/63 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication up to approximately 100 days.
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/63 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication up to approximately 100 days.
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
1.6%
1/63 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication up to approximately 100 days.
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
Other adverse events
| Measure |
Placebo
n=63 participants at risk
Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
GSK2269557 1000 mcg
n=63 participants at risk
Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
|
|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
7.9%
5/63 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication up to approximately 100 days.
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
3.2%
2/63 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication up to approximately 100 days.
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Nervous system disorders
Headache
|
7.9%
5/63 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication up to approximately 100 days.
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
11.1%
7/63 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication up to approximately 100 days.
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.2%
2/63 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication up to approximately 100 days.
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
34.9%
22/63 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication up to approximately 100 days.
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
|
Vascular disorders
Hypertension
|
6.3%
4/63 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication up to approximately 100 days.
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
0.00%
0/63 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication up to approximately 100 days.
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of investigational product.
|
Additional Information
GSK Response Center
GlaxoSmithKline
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