Trial Outcomes & Findings for A Comparison Study Between the Fixed Dose Triple Combination of Fluticasone Furoate/ Umeclidinium/ Vilanterol Trifenatate (FF/UMEC/VI) With Budesonide/Formoterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT02345161)
NCT ID: NCT02345161
Last Updated: 2018-07-13
Results Overview
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 at Week 24 was defined as the FEV1 values obtained prior to morning dose of the study treatment. Baseline was defined as the value obtained predose (0 minutes) on Day 1. Change from Baseline was calculated as the pre-dose measurement at Week 24 minus the Baseline value. The analysis was performed using a mixed model repeated measures (MMRM) method including covariates of treatment group, smoking status (screening), geographical region, visit, baseline, baseline by visit and treatment by visit interactions. ITT Population comprised of all randomized subjects excluding those who were randomized in error. Only participants with analyzable data at the given time point were analyzed.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1811 participants
Primary outcome timeframe
Baseline to Week 24
Results posted on
2018-07-13
Participant Flow
This was a phase IIIa, randomized, double-blind, double-dummy, parallel group multicenter study to evaluate once daily fluticasone furoate (FF)/umeclidinium (UMEC)/vilanterol (VI; 100 micrograms \[µg\]/62.5 µg/25 µg) inhalation versus twice daily budesonide/formoterol (400 µg/12 µg) in participants with chronic obstructive pulmonary disease.
A total of 2121 participants were screened in this study and 1811 were randomized following 2-week run-in. Of those, 1 participant was randomized in error and did not receive randomized treatment. This was followed by a 24-week treatment and 1-week follow-up periods. A sub-set of 430 participants continued in a blinded study treatment for 52 weeks.
Participant milestones
| Measure |
FF/UMEC/VI 100/62.5/25 µg
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Overall Study
STARTED
|
911
|
899
|
|
Overall Study
COMPLETED
|
866
|
842
|
|
Overall Study
NOT COMPLETED
|
45
|
57
|
Reasons for withdrawal
| Measure |
FF/UMEC/VI 100/62.5/25 µg
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
25
|
33
|
|
Overall Study
Adverse Event
|
16
|
19
|
|
Overall Study
Physician Decision
|
4
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
A Comparison Study Between the Fixed Dose Triple Combination of Fluticasone Furoate/ Umeclidinium/ Vilanterol Trifenatate (FF/UMEC/VI) With Budesonide/Formoterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Baseline characteristics by cohort
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=911 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=899 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
Total
n=1810 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.2 Years
STANDARD_DEVIATION 8.56 • n=5 Participants
|
63.7 Years
STANDARD_DEVIATION 8.71 • n=7 Participants
|
63.9 Years
STANDARD_DEVIATION 8.64 • n=5 Participants
|
|
Sex: Female, Male
Female
|
233 Participants
n=5 Participants
|
236 Participants
n=7 Participants
|
469 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
678 Participants
n=5 Participants
|
663 Participants
n=7 Participants
|
1341 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Amrican Indian or Alaskan Native
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian-East Asian Heritage
|
55 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian-South East Asian Heritag
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White-Arabic/North African Heritage
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White-White/Caucasina/Euorpean Heritage
|
771 Participants
n=5 Participants
|
759 Participants
n=7 Participants
|
1530 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
63 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: ITT Population
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 at Week 24 was defined as the FEV1 values obtained prior to morning dose of the study treatment. Baseline was defined as the value obtained predose (0 minutes) on Day 1. Change from Baseline was calculated as the pre-dose measurement at Week 24 minus the Baseline value. The analysis was performed using a mixed model repeated measures (MMRM) method including covariates of treatment group, smoking status (screening), geographical region, visit, baseline, baseline by visit and treatment by visit interactions. ITT Population comprised of all randomized subjects excluding those who were randomized in error. Only participants with analyzable data at the given time point were analyzed.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=836 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=781 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Week 24
|
0.142 Liters (L)
Standard Error 0.0083
|
-0.029 Liters (L)
Standard Error 0.0085
|
PRIMARY outcome
Timeframe: Baseline to Week 52Population: Extension Population; Only participants with analyzable data at the given time point were analyzed.
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 at Week 52 was defined as the FEV1 values obtained prior to morning dose of the study treatment. Baseline was defined as the value obtained predose (0 minutes) on Day 1. Change from Baseline was calculated as the pre-dose measurement at Week 24 minus the Baseline value. The analysis was performed using a mixed model repeated measures (MMRM) method including covariates of treatment group, smoking status (screening), geographical region, visit, baseline, baseline by visit and treatment by visit interactions. Extension Population: all participants in the ITT Population who were enrolled into the subset of participants with extension to 52 weeks.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=183 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=171 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Week 52
|
0.126 Liters (L)
Standard Error 0.0170
|
-0.053 Liters (L)
Standard Error 0.0172
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: ITT Population; Only participants with analyzable data at the given time point were analyzed.
The SGRQ-C is a disease-specific questionnaire designed to measure the impact of respiratory disease and its treatment on a COPD participant's health-related quality of life (HRQoL). SGRQ-C total score was converted to SGRQ total score (ranging from 0-100) according to manual. In addition to an overall summary (total) score, scores for the individual domains of Symptoms, Activity, and Impacts (each ranging from 0-100) are produced. A decrease in score indicated improvement in quality of life. The minimum clinically important difference (MCID) for this instrument is a 4-point improvement (decrease from Baseline). Baseline was defined as the value obtained predose on Day 1. Change from Baseline was calculated as total score at Week 24 minus the Baseline value. The analysis for SGRQ total score was performed using a MMRM method including covariates of treatment group, smoking status (screening), geographical region, visit, baseline, baseline by visit and treatment by visit interactions
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=846 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=791 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Change From Baseline in St George's Respiratory Questionnaire-Chronic Obstructive Pulmonary Disease (COPD; SGRQ) Total Score for COPD Participants at Week 24
|
-6.6 Scores on a scale
Standard Error 0.45
|
-4.3 Scores on a scale
Standard Error 0.46
|
PRIMARY outcome
Timeframe: Baseline to Week 52Population: Extension Population; Only participants with analyzable data at the given time point were analyzed.
The SGRQ-C is a disease-specific questionnaire designed to measure the impact of respiratory disease and its treatment on a COPD participant's health-related quality of life (HRQoL). SGRQ-C total score was converted to SGRQ total score (ranging from 0-100) according to manual. In addition to an overall summary (total) score, scores for the individual domains of Symptoms, Activity, and Impacts (each ranging from 0-100) are produced. A decrease in score indicated improvement in quality of life. The minimum clinically important difference (MCID) for this instrument is a 4-point improvement (decrease from Baseline). Baseline was defined as the value obtained predose on Day 1. Change from Baseline was calculated as total score at Week 52 minus the Baseline value. The analysis for SGRQ total score was performed using a MMRM method including covariates of treatment group, smoking status (screening), geographical region, visit, baseline, baseline by visit and treatment by visit interactions.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=182 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=174 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Change From Baseline in St George's Respiratory Questionnaire-COPD; SGRQ Total Score for COPD Participants at Week 52
|
-4.6 Scores on a scale
Standard Error 1.01
|
-1.9 Scores on a scale
Standard Error 1.03
|
SECONDARY outcome
Timeframe: Week 24Population: ITT Population; Only participants with analyzable data at the given time point were analyzed.
The TDI measures change in the participant's dyspnoea from Baseline. The scores in both indexes depend on ratings for three different categories: functional impairment; magnitude of task; and magnitude of effort. Each of these scales had a possible score ranging from -6 (major deterioration) to +6 (major improvement). TDI focal score was calculated as the sum of the three individual scores and then divided by 2 (so the range of the TDI focal score is -9 to +9). TDI was measured at Week 4 and Week 24. Analysis performed using a repeated measures model with covariates of treatment group, smoking status (screening), geographical region, visit, BDI focal score, BDI focal score by visit and treatment by visit interactions.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=839 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=788 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Transitional Dyspnea Index (TDI) Focal Score Expressed as Least Square Mean at Week 24
|
2.29 Scores on a scale
Standard Error 0.096
|
1.72 Scores on a scale
Standard Error 0.099
|
SECONDARY outcome
Timeframe: Week 52Population: Extension Population; Only participants with analyzable data at the given time point were analyzed.
The TDI measures change in the participant's dyspnoea from Baseline. The scores in both indexes depend on ratings for three different categories: functional impairment; magnitude of task; and magnitude of effort. Each of these scales had a possible score ranging from -6 (major deterioration) to +6 (major improvement). TDI focal score was calculated as the sum of the three individual scores and then divided by 2 (so the range of the TDI focal score is -9 to +9). TDI was measured at Weeks 4, 24 and 52. Analysis performed using a repeated measures model with covariates of treatment group, smoking status (screening), geographical region, visit, BDI focal score, BDI focal score by visit and treatment by visit interactions
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=182 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=174 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Transitional Dyspnea Index (TDI) Focal Score Expressed as Least Square Mean at Week 52
|
1.74 Scores on a scale
Standard Error 0.221
|
1.39 Scores on a scale
Standard Error 0.226
|
SECONDARY outcome
Timeframe: Up to Week 24Population: ITT Population; Only participants with analyzable data at the given time point were analyzed.
Participants were asked to complete the daily activity question as part of the eDiary, which included the following options: 0: fewer activities, 1: no affect on my activities, and 2: more activities than usual. Daily activity question percentage of days with score of 2 over Weeks 1-24 was analysed using an ANCOVA model with covariates of treatment group, smoking status (screening), geographical region and baseline.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=909 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=894 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Daily Activity Question Percentage of Days Reporting a Score of 2 up to Week 24
|
0.0 Percentage of days
Standard Error 0.38
|
-0.1 Percentage of days
Standard Error 0.39
|
SECONDARY outcome
Timeframe: Up to Week 52Population: Extension Population; Only participants with analyzable data at the given time point were analyzed.
Participants were asked to complete the daily activity question as aprt of the eDiary, which included the following options: 0: fewer activities, 1: no affect on my activities, and 2: more activities than usual. Daily activity question percentage of days with score of 2 over Weeks 1-24 was analysed using an ANCOVA model with covariates of treatment group, smoking status (screening), geographical region and baseline.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=210 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=219 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Daily Activity Question Percentage of Days Reporting a Score of 2 up to Week 52
|
0.0 Percentage of days
Standard Error 0.70
|
0.3 Percentage of days
Standard Error 0.69
|
SECONDARY outcome
Timeframe: Up to Week 24Population: ITT Population; Only participants with analyzable data at the given time point were analyzed.
The mean annual moderate and severe COPD exacerbations during the treatment (trt) period (per participant \[par.\] per year) was assessed. The event rate for exacerbations was calculated as the number of events x 1000 divided by the total participant exposure during the time-period of interest. An exacerbation of COPD, is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence \[color\]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptoms (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. Analysis performed using a generalised linear model assuming a negative binomial distribution and covariates of treatment group, exacerbation history (0, 1, \>=2 moderate/severe), smoking status (screening), geographical region and post-bronchodilator percent predicted FEV1 (day 1).
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=907 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=892 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Mean Annual On-treatment Moderate and/or Severe COPD Exacerbations up to Week 24
|
0.22 Exacerbations per participant per year
Interval 0.18 to 0.28
|
0.34 Exacerbations per participant per year
Interval 0.28 to 0.42
|
SECONDARY outcome
Timeframe: Up to Week 52Population: Extension Population; Only participants with analyzable data at the given time point were analyzed.
The mean annual moderate and severe COPD exacerbations during the treatment (trt) period (per participant \[par.\] per year) was assessed. The event rate for exacerbations was calculated as the number of events x 1000 divided by the total participant exposure during the time-period of interest. An exacerbation of COPD, is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence \[color\]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptoms (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. Analysis performed using a generalised linear model assuming a negative binomial distribution and covariates of treatment group, exacerbation history (0, 1, \>=2 moderate/severe), smoking status (screening), geographical region and post-bronchodilator percent predicted FEV1 (day 1).
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=210 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=219 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Mean Annual On-treatment Moderate and/or Severe COPD Exacerbations up to Week 52
|
0.20 Exacerbations per participant per year
Interval 0.15 to 0.28
|
0.36 Exacerbations per participant per year
Interval 0.28 to 0.47
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: ITT Population
The EXACT-PRO is a 14 item instrument designed to capture information on the occurrence, frequency, severity, and duration of exacerbations of disease in participants with COPD. EXACT-RS consists of 11 items from the 14 item EXACT-PRO instrument and has a scoring range of 0-40. Three subscales are used to describe different symptoms; dyspnoea (range 0-17), cough and sputum (range 0-11) and chest symptoms (range 0-12). Baseline was defined as the mean value during the period between Visits 1 and 2. Mean scores were calculated for each four weekly period and change from Baseline was calculated as four weekly score minus the Baseline value. Four weekly intervals were analyzed using a MMRM method with covariates of treatment group, smoking status (screening), geographical region, time period, baseline, baseline by time period and treatment by time period interactions. Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title).
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=911 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=899 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean Exacerbations of Chronic Pulmonary Disease Tool (EXACT)-RS Scores up to Week 24
Week 1-4, n=870,859
|
-1.45 Scores on a scale
Standard Error 0.106
|
-0.50 Scores on a scale
Standard Error 0.106
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean Exacerbations of Chronic Pulmonary Disease Tool (EXACT)-RS Scores up to Week 24
Week 5-8, n=851,830
|
-2.00 Scores on a scale
Standard Error 0.129
|
-0.77 Scores on a scale
Standard Error 0.130
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean Exacerbations of Chronic Pulmonary Disease Tool (EXACT)-RS Scores up to Week 24
Week 9-12, n=841,813
|
-2.23 Scores on a scale
Standard Error 0.141
|
-1.05 Scores on a scale
Standard Error 0.143
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean Exacerbations of Chronic Pulmonary Disease Tool (EXACT)-RS Scores up to Week 24
Week 13-16, n=831,802
|
-2.42 Scores on a scale
Standard Error 0.150
|
-1.09 Scores on a scale
Standard Error 0.151
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean Exacerbations of Chronic Pulmonary Disease Tool (EXACT)-RS Scores up to Week 24
Week 17-20, n=828,788
|
-2.43 Scores on a scale
Standard Error 0.156
|
-1.02 Scores on a scale
Standard Error 0.159
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean Exacerbations of Chronic Pulmonary Disease Tool (EXACT)-RS Scores up to Week 24
Week 21-24, n=825,783
|
-2.31 Scores on a scale
Standard Error 0.157
|
-0.96 Scores on a scale
Standard Error 0.160
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean Exacerbations of Chronic Pulmonary Disease Tool (EXACT)-RS Scores up to Week 24
Breathlessness score, Week 1-4, n=870,859
|
-0.71 Scores on a scale
Standard Error 0.057
|
-0.20 Scores on a scale
Standard Error 0.057
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean Exacerbations of Chronic Pulmonary Disease Tool (EXACT)-RS Scores up to Week 24
Breathlessness score, Week 5-8, n=851,830
|
-0.95 Scores on a scale
Standard Error 0.069
|
-0.26 Scores on a scale
Standard Error 0.070
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean Exacerbations of Chronic Pulmonary Disease Tool (EXACT)-RS Scores up to Week 24
Breathlessness score, Week 9-12, n=841,813
|
-1.03 Scores on a scale
Standard Error 0.076
|
-0.34 Scores on a scale
Standard Error 0.076
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean Exacerbations of Chronic Pulmonary Disease Tool (EXACT)-RS Scores up to Week 24
Breathlessness score, Week 13-16, n=831, 802
|
-1.11 Scores on a scale
Standard Error 0.080
|
-0.36 Scores on a scale
Standard Error 0.081
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean Exacerbations of Chronic Pulmonary Disease Tool (EXACT)-RS Scores up to Week 24
Breathlessness score, Week 17-20, n=828,788
|
-1.10 Scores on a scale
Standard Error 0.084
|
-0.31 Scores on a scale
Standard Error 0.085
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean Exacerbations of Chronic Pulmonary Disease Tool (EXACT)-RS Scores up to Week 24
Breathlessness score, Week 21-24, n=825,783
|
-1.07 Scores on a scale
Standard Error 0.085
|
-0.30 Scores on a scale
Standard Error 0.087
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean Exacerbations of Chronic Pulmonary Disease Tool (EXACT)-RS Scores up to Week 24
Cough, sputum score, Week 1-4, n=870,859
|
-0.41 Scores on a scale
Standard Error 0.031
|
-0.24 Scores on a scale
Standard Error 0.031
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean Exacerbations of Chronic Pulmonary Disease Tool (EXACT)-RS Scores up to Week 24
Cough, sputum score, Week 5-8, n=851,830
|
-0.59 Scores on a scale
Standard Error 0.037
|
-0.39 Scores on a scale
Standard Error 0.038
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean Exacerbations of Chronic Pulmonary Disease Tool (EXACT)-RS Scores up to Week 24
Cough, sputum score, Week 9-12, n=841,813
|
-0.67 Scores on a scale
Standard Error 0.041
|
-0.50 Scores on a scale
Standard Error 0.041
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean Exacerbations of Chronic Pulmonary Disease Tool (EXACT)-RS Scores up to Week 24
Cough, sputum score, Week 13-16, n=831,802
|
-0.74 Scores on a scale
Standard Error 0.043
|
-0.53 Scores on a scale
Standard Error 0.043
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean Exacerbations of Chronic Pulmonary Disease Tool (EXACT)-RS Scores up to Week 24
Cough, sputum score, Week 17-20, n=828,788
|
-0.77 Scores on a scale
Standard Error 0.045
|
-0.53 Scores on a scale
Standard Error 0.045
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean Exacerbations of Chronic Pulmonary Disease Tool (EXACT)-RS Scores up to Week 24
Cough, sputum score, Week 21-24, n=825,783
|
-0.72 Scores on a scale
Standard Error 0.046
|
-0.50 Scores on a scale
Standard Error 0.046
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean Exacerbations of Chronic Pulmonary Disease Tool (EXACT)-RS Scores up to Week 24
Chest score, Week 1-4, n=870,859
|
-0.33 Scores on a scale
Standard Error 0.034
|
-0.06 Scores on a scale
Standard Error 0.035
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean Exacerbations of Chronic Pulmonary Disease Tool (EXACT)-RS Scores up to Week 24
Chest score, Week 5-8, n=851,830
|
-0.46 Scores on a scale
Standard Error 0.042
|
-0.12 Scores on a scale
Standard Error 0.043
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean Exacerbations of Chronic Pulmonary Disease Tool (EXACT)-RS Scores up to Week 24
Chest score, Week 9-12, n=841,813
|
-0.54 Scores on a scale
Standard Error 0.046
|
-0.20 Scores on a scale
Standard Error 0.047
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean Exacerbations of Chronic Pulmonary Disease Tool (EXACT)-RS Scores up to Week 24
Chest score, Week 13-16, n=831,802
|
-0.58 Scores on a scale
Standard Error 0.048
|
-0.20 Scores on a scale
Standard Error 0.048
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean Exacerbations of Chronic Pulmonary Disease Tool (EXACT)-RS Scores up to Week 24
Chest score, Week 17-20, n=828,788
|
-0.57 Scores on a scale
Standard Error 0.050
|
-0.17 Scores on a scale
Standard Error 0.050
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean Exacerbations of Chronic Pulmonary Disease Tool (EXACT)-RS Scores up to Week 24
Chest score, Week 21-24, n=825,783
|
-0.53 Scores on a scale
Standard Error 0.050
|
-0.17 Scores on a scale
Standard Error 0.051
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: Extension Population
The EXACT-PRO is a 14 item instrument designed to capture information on the occurrence, frequency, severity, and duration of exacerbations of disease in participants with COPD. EXACT-RS consists of 11 items from the 14 item EXACT-PRO instrument and has a scoring range of 0-40. Three subscales are used to describe different symptoms; dyspnoea (range 0-17), cough and sputum (range 0-11) and chest symptoms (range 0-12). Baseline was defined as the mean value during the period between Visits 1 and 2. Mean scores were calculated for each four weekly period and change from Baseline was calculated as four weekly score minus the Baseline value. Four weekly intervals were analyzed using a MMRM method with covariates of treatment group, smoking status (screening), geographical region, time period, baseline, baseline by time period and treatment by time period interactions. Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title).
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=210 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=220 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Chest scores, Week 9-12, n=201, 206
|
-0.51 Scores on a scale
Standard Error 0.093
|
-0.24 Scores on a scale
Standard Error 0.092
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Chest scores, Week 17-20, n=201, 199
|
-0.67 Scores on a scale
Standard Error 0.104
|
-0.29 Scores on a scale
Standard Error 0.103
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Chest scores, Week 21-24, n=202, 197
|
-0.68 Scores on a scale
Standard Error 0.102
|
-0.30 Scores on a scale
Standard Error 0.101
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Chest scores, Week 41-44, n=180, 174
|
-0.58 Scores on a scale
Standard Error 0.108
|
-0.16 Scores on a scale
Standard Error 0.108
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Chest scores, Week 45-48, n=180, 173
|
-0.57 Scores on a scale
Standard Error 0.113
|
-0.13 Scores on a scale
Standard Error 0.113
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Week 1-4, n=205, 213
|
-1.24 Scores on a scale
Standard Error 0.222
|
-0.72 Scores on a scale
Standard Error 0.218
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Week 5-8, n=203, 208
|
-1.97 Scores on a scale
Standard Error 0.265
|
-0.90 Scores on a scale
Standard Error 0.260
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Week 9-12, n=201, 206
|
-2.18 Scores on a scale
Standard Error 0.298
|
-1.21 Scores on a scale
Standard Error 0.294
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Week 13-16, n=201, 204
|
-2.53 Scores on a scale
Standard Error 0.317
|
-1.52 Scores on a scale
Standard Error 0.313
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Week 17-20, n=201, 199
|
-2.64 Scores on a scale
Standard Error 0.342
|
-1.53 Scores on a scale
Standard Error 0.338
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Week 21-24, n=202, 197
|
-2.63 Scores on a scale
Standard Error 0.341
|
-1.52 Scores on a scale
Standard Error 0.338
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Week 25-28, n=194, 186
|
-2.48 Scores on a scale
Standard Error 0.349
|
-1.16 Scores on a scale
Standard Error 0.347
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Week 29-32, n=192, 181
|
-2.33 Scores on a scale
Standard Error 0.350
|
-0.90 Scores on a scale
Standard Error 0.349
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Week 33-36, n=187, 180
|
-2.12 Scores on a scale
Standard Error 0.367
|
-0.62 Scores on a scale
Standard Error 0.366
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Week 37-40, n=185, 177
|
-2.34 Scores on a scale
Standard Error 0.359
|
-1.11 Scores on a scale
Standard Error 0.358
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Week 41-44, n=180, 174
|
-2.30 Scores on a scale
Standard Error 0.363
|
-0.81 Scores on a scale
Standard Error 0.362
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Week 45-48, n=180, 173
|
-2.17 Scores on a scale
Standard Error 0.371
|
-0.64 Scores on a scale
Standard Error 0.371
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
EXACT-RS Scores, Week 49-52, n=179, 171
|
-2.03 Scores on a scale
Standard Error 0.370
|
-0.61 Scores on a scale
Standard Error 0.370
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Breathlessness scores, Week 1-4, n=205, 213
|
-0.64 Scores on a scale
Standard Error 0.120
|
-0.31 Scores on a scale
Standard Error 0.118
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Breathlessness scores, Week 5-8, n=203, 208
|
-0.93 Scores on a scale
Standard Error 0.147
|
-0.32 Scores on a scale
Standard Error 0.145
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Breathlessness scores, Week 9-12, n=201, 206
|
-1.05 Scores on a scale
Standard Error 0.167
|
-0.44 Scores on a scale
Standard Error 0.164
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Breathlessness scores, Week 13-16, n=201, 204
|
-1.19 Scores on a scale
Standard Error 0.175
|
-0.57 Scores on a scale
Standard Error 0.173
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Breathlessness scores, Week 17-20, n=201, 199
|
-1.17 Scores on a scale
Standard Error 0.189
|
-0.50 Scores on a scale
Standard Error 0.186
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Breathlessness scores, Week 21-24, n=202, 197
|
-1.13 Scores on a scale
Standard Error 0.190
|
-0.50 Scores on a scale
Standard Error 0.188
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Breathlessness scores, Week 25-28, n=194, 186
|
-1.14 Scores on a scale
Standard Error 0.195
|
-0.38 Scores on a scale
Standard Error 0.194
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Breathlessness scores, Week 29-32, n=192, 181
|
-1.11 Scores on a scale
Standard Error 0.196
|
-0.26 Scores on a scale
Standard Error 0.194
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Breathlessness scores, Week 33-36, n=187, 180
|
-1.08 Scores on a scale
Standard Error 0.204
|
-0.14 Scores on a scale
Standard Error 0.203
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Breathlessness scores, Week 37-40, n=185, 177
|
-1.13 Scores on a scale
Standard Error 0.203
|
-0.37 Scores on a scale
Standard Error 0.202
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Breathlessness scores, Week 41-44, n=180, 174
|
-1.06 Scores on a scale
Standard Error 0.208
|
-0.24 Scores on a scale
Standard Error 0.208
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Breathlessness scores, Week 45-48, n=180, 173
|
-0.97 Scores on a scale
Standard Error 0.211
|
-0.11 Scores on a scale
Standard Error 0.211
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Breathlessness scores, Week 49-52, n=179, 171
|
-0.96 Scores on a scale
Standard Error 0.207
|
-0.08 Scores on a scale
Standard Error 0.207
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Cough and sputum scores, Week 1-4, n=205, 213
|
-0.34 Scores on a scale
Standard Error 0.065
|
-0.32 Scores on a scale
Standard Error 0.064
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Cough and sputum scores, Week 5-8, n=203, 208
|
-0.59 Scores on a scale
Standard Error 0.076
|
-0.44 Scores on a scale
Standard Error 0.074
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Cough and sputum scores, Week 9-12, n=201, 206
|
-0.63 Scores on a scale
Standard Error 0.083
|
-0.52 Scores on a scale
Standard Error 0.082
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Cough and sputum scores, Week 13-16, n=201, 204
|
-0.73 Scores on a scale
Standard Error 0.088
|
-0.62 Scores on a scale
Standard Error 0.087
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Cough and sputum scores, Week 17-20, n=201, 199
|
-0.83 Scores on a scale
Standard Error 0.095
|
-0.73 Scores on a scale
Standard Error 0.094
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Cough and sputum scores, Week 21-24, n=202, 197
|
-0.83 Scores on a scale
Standard Error 0.098
|
-0.71 Scores on a scale
Standard Error 0.097
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Cough and sputum scores, Week 25-28, n=194, 186
|
-0.73 Scores on a scale
Standard Error 0.097
|
-0.57 Scores on a scale
Standard Error 0.097
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Cough and sputum scores, Week 29-32, n=192, 181
|
-0.68 Scores on a scale
Standard Error 0.096
|
-0.48 Scores on a scale
Standard Error 0.096
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Cough and sputum scores, Week 33-36, n=187, 180
|
-0.56 Scores on a scale
Standard Error 0.099
|
-0.40 Scores on a scale
Standard Error 0.099
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Cough and sputum scores, Week 37-40, n=185, 177
|
-0.65 Scores on a scale
Standard Error 0.097
|
-0.54 Scores on a scale
Standard Error 0.097
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Cough and sputum scores, Week 41-44, n=180, 174
|
-0.66 Scores on a scale
Standard Error 0.101
|
-0.41 Scores on a scale
Standard Error 0.102
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Cough and sputum scores, Week 45-48, n=180, 173
|
-0.66 Scores on a scale
Standard Error 0.098
|
-0.39 Scores on a scale
Standard Error 0.099
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Cough and sputum scores, Week 49-52, n=179, 171
|
-0.61 Scores on a scale
Standard Error 0.100
|
-0.44 Scores on a scale
Standard Error 0.100
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Chest scores, Week 1-4, n=205, 213
|
-0.27 Scores on a scale
Standard Error 0.069
|
-0.09 Scores on a scale
Standard Error 0.068
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Chest scores, Week 5-8, n=203, 208
|
-0.46 Scores on a scale
Standard Error 0.084
|
-0.13 Scores on a scale
Standard Error 0.082
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Chest scores, Week 13-16, n=201, 204
|
-0.61 Scores on a scale
Standard Error 0.097
|
-0.31 Scores on a scale
Standard Error 0.095
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Chest scores, Week 25-28, n=194, 186
|
-0.63 Scores on a scale
Standard Error 0.105
|
-0.21 Scores on a scale
Standard Error 0.104
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Chest scores, Week 29-32, n=192, 181
|
-0.55 Scores on a scale
Standard Error 0.107
|
-0.16 Scores on a scale
Standard Error 0.107
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Chest scores, Week 33-36, n=187, 180
|
-0.48 Scores on a scale
Standard Error 0.111
|
-0.08 Scores on a scale
Standard Error 0.111
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Chest scores, Week 37-40, n=185, 177
|
-0.57 Scores on a scale
Standard Error 0.107
|
-0.20 Scores on a scale
Standard Error 0.107
|
|
Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52
Chest scores, Week 49-52, n=179, 171
|
-0.49 Scores on a scale
Standard Error 0.115
|
-0.08 Scores on a scale
Standard Error 0.115
|
SECONDARY outcome
Timeframe: Up to Week 24Population: ITT Population
An AE was any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. These included an exacerbation of a chronic or intermittent pre-existing condition. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; or all events of possible drug-induced liver injury. Abnormal and clinically significant laboratory test results were also recorded as an AE or SAE. COPD exacerbations were an expected disease-related outcome and were not to be recorded as an AE, unless they met the definition of an SAE. Participants were not to be withdrawn from the study due to COPD exacerbations and their evaluation was an efficacy endpoint.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=911 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=899 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Number of Participants With Any On-treatment Adverse Event (AE) and Serious Adverse Event (SAE) in the Treatment Period
Any AE
|
354 Participants
|
339 Participants
|
|
Number of Participants With Any On-treatment Adverse Event (AE) and Serious Adverse Event (SAE) in the Treatment Period
Any SAE
|
49 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: Up to Week 52Population: Extension Population
An AE was any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. These included an exacerbation of a chronic or intermittent pre-existing condition. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; or all events of possible drug-induced liver injury. Abnormal and clinically significant laboratory test results were also recorded as an AE or SAE. COPD exacerbations were an expected disease-related outcome and were not to be recorded as an AE, unless they met the definition of an SAE. Participants were not to be withdrawn from the study due to COPD exacerbations and their evaluation was an efficacy endpoint.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=210 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=220 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Number of Participants With Any On-treatment AE/SAEs in the Extension Part of the Study
Any AE
|
100 Participants
|
122 Participants
|
|
Number of Participants With Any On-treatment AE/SAEs in the Extension Part of the Study
Any SAE
|
21 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Up to Week 24Population: ITT Population.
All suspected pneumonias required confirmation as defined by the presence of new infiltrate(s) on chest x-ray and at least 2 of the following signs and symptoms: Increased cough, Increased sputum purulence (colour) or production, Auscultatory findings of adventitious sounds , Dyspnea or tachypnea, Fever (oral temperature \> 37.5 °C), Elevated white blood cells (WBC) (\>10,000/millimeter \[mm\^3\] or \>15 percent immature forms) or Hypoxemia (hemoglobin/oxygen \[HbO2\] saturation \<88 percent or at least 2 percent lower than Baseline value).
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=911 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=899 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Number of Participants With an On-treatment Penumonia Event in the Treatment Period
|
20 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to Week 52Population: Extension Population
All suspected pneumonias required confirmation as defined by the presence of new infiltrate(s) on chest x-ray AND at least 2 of the following signs and symptoms: Increased cough, Increased sputum purulence (colour) or production, Auscultatory findings of adventitious sounds , Dyspnea or tachypnea, Fever (oral temperature \> 37.5 °C), Elevated WBC (\>10,000/mm3 or \>15 percent immature forms) orr Hypoxemia (HbO2 saturation \<88 percent or at least 2 percent lower than Baseline value).
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=210 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=220 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Number of Participants With an On-treatment Penumonia Event in the Extension Part of the Study
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to Week 24Population: ITT Population
Cardiovascular safety was monitored via AE reporting with categorization and analysis of adverse events of special interest (AESIs) including cardiac arrhythmia, cardiac failure, ischemic heart disease, hypertension, and central nervous system hemorrhages and cerebrovascular conditions. In addition, ECGs and vital signs were measured in all subjects and24-hour Holter monitoring was performed in a predefined subset. Pre-specified MACE analysis was conducted based on adjudicated CV deaths and investigator-reported non-fatal AEs. Number of participants with any of the following MACE events were to be included per the broad and narrow analyses: Broad MACE criteria (ischemic heart disease standardized MedDRA query \[SMQ; myocardial infarction SMQ and other ischemic diseases\]) and narrow MACE criteria (myocardial infarction \[acute myocardial infarction\].
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=911 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=899 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Number of Participants With Any On-treatment Cardiovascular (CV) Events (Including Supraventricular Arrhythmia and Non Fatal Myocardial Infarction) in the Treatment Period
Any MACE, Narrow definition
|
4 Participants
|
7 Participants
|
|
Number of Participants With Any On-treatment Cardiovascular (CV) Events (Including Supraventricular Arrhythmia and Non Fatal Myocardial Infarction) in the Treatment Period
Any MACE, Broad definition
|
12 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Up to Week 52Population: Extension Population
Cardiovascular safety was monitored via AE reporting with categorization and analysis of adverse events of special interest (AESIs) including cardiac arrhythmia, cardiac failure, ischemic heart disease, hypertension, and central nervous system hemorrhages and cerebrovascular conditions. In addition, ECGs and vital signs were measured in all subjects and24-hour Holter monitoring was performed in a predefined subset. Pre-specified MACE analysis was conducted based on adjudicated CV deaths and investigator-reported non-fatal AEs. Number of participants with any of the following MACE events were to be included per the broad and narrow analyses: Broad MACE criteria (ischemic heart disease standardized MedDRA query \[SMQ; myocardial infarction SMQ and other ischemic diseases\]) and narrow MACE criteria (myocardial infarction \[acute myocardial infarction\]
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=210 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=220 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Number of Participants With Any On-treatment CV Events (Including Supraventricular Arrhythmia and Non Fatal Myocardial Infarction) in the Extension Part of the Study
Any MACE, Broad definition
|
7 Participants
|
5 Participants
|
|
Number of Participants With Any On-treatment CV Events (Including Supraventricular Arrhythmia and Non Fatal Myocardial Infarction) in the Extension Part of the Study
Any MACE, Narrow definition
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: ITT Population; Only participants with analyzable data at the given time point were analyzed.
A single 12-lead electrocardiogram (ECG) and rhythm strip were recorded after measurement of vital signs and spirometry. Recordings were made at Screening (Visit 1) and approximately 15-45 minutes after dosing on treatment Week 4 and Week 24 or IP Discontinuation Visit. Change from Baseline in ECG heart rate was summarized for each post-Baseline assessment up to Week 24. Change from Baseline was calculated as the individual post-Baseline value at Week 24 minus the Baseline value. Baseline value is defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). All ECG measurements were made with the participants in a supine position having rested in this position for approximately 5 minutes before each reading.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=840 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=787 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Change From Baseline in Heart Rate at Week 24
|
-1.1 Beats per minute (Bpm)
Standard Deviation 11.51
|
-1.2 Beats per minute (Bpm)
Standard Deviation 10.91
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Extension Population; Only participants with analyzable data at the given time point were analyzed.
A single 12-lead ECG and rhythm strip were recorded after measurement of vital signs and spirometry. Recordings were made at Screening (Visit 1) and approximately 15-45 minutes after dosing on treatment Week 4, Week 24 and Week 52 or IP Discontinuation Visit. Change from Baseline in ECG heart rate was summarized for each post-Baseline assessment up to Week 24. Change from Baseline was calculated as the individual post-Baseline value at Week 52 minus the Baseline value. Baseline value is defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). All ECG measurements were made with the participants in a supine position having rested in this position for approximately 5 minutes before each reading.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=181 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=169 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Change From Baseline in Heart Rate at Week 52
|
0.2 Bpm
Standard Deviation 11.30
|
-1.0 Bpm
Standard Deviation 10.77
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: ITT population
A single 12-lead ECG and rhythm strip were recorded after measurement of vital signs and spirometry. Recordings were made at Screening (Visit 1) and approximately 15-45 minutes after dosing on treatment Week 4 and Week 24 or IP Discontinuation Visit. Change from Baseline in ECG QTcF and PR interval was summarized for each post-Baseline assessment up to Week 24. Change from Baseline was calculated as the individual post-Baseline value at Week 24 minus the Baseline value. Baseline value is defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). All ECG measurements were made with the participants in a supine position having rested in this position for approximately 5 minutes before each reading.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=911 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=899 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Change From Baseline in Corrected QT Interval Using Fridericia's Correction (QTcF) and PR Interval at Week 24
QTcF, n=840,787
|
2.5 Milliseconds (msec)
Standard Error 0.56
|
0.6 Milliseconds (msec)
Standard Error 0.58
|
|
Change From Baseline in Corrected QT Interval Using Fridericia's Correction (QTcF) and PR Interval at Week 24
PR, n=812,766
|
-0.1 Milliseconds (msec)
Standard Error 0.54
|
0.5 Milliseconds (msec)
Standard Error 0.56
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Extension Population
Single 12-lead ECG and rhythm strip were recorded after measurement of vital signs and spirometry. Recordings were made at Screening (Visit 1) and approximately 15-45 minutes after dosing on treatment Week 4, Week 24 and Week 52 or IP Discontinuation Visit. Change from Baseline in ECG QTcF and PR interval was summarized for each post-Baseline assessment up to Week 24. Change from Baseline was calculated as the individual post-Baseline value at Week 52 minus the Baseline value. Baseline value is defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title).
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=210 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=220 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Change From Baseline in QTcF and PR Interval at Week 52
QTcF, n=181,169
|
1.4 Msec
Standard Error 1.27
|
2.4 Msec
Standard Error 1.31
|
|
Change From Baseline in QTcF and PR Interval at Week 52
PR, n=174,160
|
1.6 Msec
Standard Error 1.09
|
1.4 Msec
Standard Error 1.13
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: ITT Population; Only participants with analyzable data at the given time point were analyzed.
A single 12-lead ECG and rhythm strip were recorded after measurement of vital signs and spirometry. Recordings were made at Screening (Visit 1) and approximately 15-45 minutes after dosing on treatment Week 4 and Week 24 or IP Discontinuation Visit. Change from Baseline in QTcB was summarized for each post-Baseline assessment up to Week 24. Change from Baseline was calculated as the individual post-Baseline value at Week 24 minus the Baseline value. Baseline value is defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). All ECG measurements were made with the participants in a supine position having rested in this position for approximately 5 minutes before each reading.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=840 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=787 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Change From Baseline in QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB) at Week 24
|
1.5 Msec
Standard Deviation 21.00
|
-0.7 Msec
Standard Deviation 20.48
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Extension Population; Only participants with analyzable data at the given time point were analyzed.
A single 12-lead ECG and rhythm strip were recorded after measurement of vital signs and spirometry. Recordings were made at Screening (Visit 1) and approximately 15-45 minutes after dosing on treatment Week 4, Week 24, and Week 52 or IP Discontinuation Visit. Change from Baseline in QTcB was summarized for each post-Baseline assessment up to Week 52. Change from Baseline was calculated as the individual post-Baseline value at Week 52 minus the Baseline value. Baseline value is defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). All ECG measurements were made with the participants in a supine position having rested in this position for approximately 5 minutes before each reading.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=181 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=169 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Change From Baseline in QTcB at Week 52
|
0.9 Msec
Standard Deviation 21.30
|
2.2 Msec
Standard Deviation 22.46
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: ITT Population; Only participants with analyzable data at the given time point were analyzed.
Vital signs were obtained at the Screening Visit and prior to taking the morning dose of study treatment and prior to conducting spirometry at Week 4 and Week 24 or at the Study Treatment Discontinuation Visit. A single set of blood pressure (systolic and diastolic) measurements were collected taken after the participant had rested for 5 minutes in the sitting position. Change from Baseline values for systolic and diastolic BP (SBP and DBP) at Week 24 were summarised and these data were analyzed using MMRM analysis. Baseline was defined as the values from most recent assessment prior to randomization which records both systolic and diastolic BP (generally Screening but could be a test repeat).
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=855 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=805 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Change From Baseline in Systolic and Diastolic Blood Pressures (BP) at Week 24
SBP
|
-1.0 Millimeter of mercury (mmHg)
Standard Error 0.39
|
-1.1 Millimeter of mercury (mmHg)
Standard Error 0.40
|
|
Change From Baseline in Systolic and Diastolic Blood Pressures (BP) at Week 24
DBP
|
-0.3 Millimeter of mercury (mmHg)
Standard Error 0.27
|
-0.5 Millimeter of mercury (mmHg)
Standard Error 0.27
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Extension Population; Only participants with analyzable data at the given time point were analyzed.
Vital signs were obtained at the Screening Visit and prior to taking the morning dose of study treatment and prior to conducting spirometry at Week 4, Week 24, and Week 52 or at the Study Treatment Discontinuation Visit. A single set of blood pressure (systolic and diastolic) measurements were taken after the participant had rested for 5 minutes in the sitting position. Change from Baseline values for systolic and diastolic BP (SBP and DBP) at Week 52 were summarised and these data were analyzed using MMRM analysis. Baseline was defined as the values from most recent assessment prior to randomization which records both systolic and diastolic BP (generally Screening but could be a test repeat).
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=184 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=175 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Change From Baseline in Systolic and Diastolic Blood Pressures (BP) at Week 52
DBP
|
-0.4 mmHg
Standard Error 0.52
|
0.4 mmHg
Standard Error 0.53
|
|
Change From Baseline in Systolic and Diastolic Blood Pressures (BP) at Week 52
SBP
|
-1.3 mmHg
Standard Error 0.83
|
0.3 mmHg
Standard Error 0.85
|
SECONDARY outcome
Timeframe: Up to Week 24Population: Holter Monitoring Population; Only participants with analyzable data at the given time point were analyzed.
The 24-hour holter measurements were obtained at Screening and 24 hours prior to Week 24 (Visits 1 and 6). The number of participants with clinically significant change (abnormal) were reported. Holter Monitoring Population: all participants in the ITT Population who had at least one holter monitoring evaluation.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=212 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=206 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Number of Participants With Any Abnormal Holter Electrocardiogram (ECG) Finding at Week 24
|
180 Participants
|
165 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: ITT Population; Only participants with analyzable data at the given time point were analyzed.
Pulse rate was obtained at the Screening Visit and prior to taking the morning dose of study treatment and prior to conducting spirometry at Week 4 and Week 24 or at the Study Treatment Discontinuation. Pulse rate was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Change from Baseline values for pulse rate at Week 24 were summarised and these data were analyzed using MMRM analysis. Baseline was defined as the values from most recent assessment prior to randomization (generally Screening but could be a test repeat).
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=855 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=805 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Change From Baseline in Pulse Rate at Week 24
|
-0.5 Bpm
Standard Error 0.31
|
-0.8 Bpm
Standard Error 0.32
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Extension Population; Only participants with analyzable data at the given time point were analyzed.
Pulse rate was obtained at the Screening Visit and prior to taking the morning dose of study treatment and prior to conducting spirometry at Week 4, Week 24, and Week 52 or at the Study Treatment Discontinuation. Pulse rate was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Change from Baseline values for pulse rate at Week 52 were summarized and these data were analyzed using MMRM analysis. Baseline was defined as the values from most recent assessment prior to randomization (generally Screening but could be a test repeat).
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=184 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=175 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Change From Baseline in Pulse Rate at Week 52
|
0.7 Bpm
Standard Error 0.67
|
-1.9 Bpm
Standard Error 0.69
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: ITT Population
Hematology laboratory assessments included basophils, eosinophils, lymphocytes, monocytes, neutrophils, total neutrophil, leukocytes, and platelets; parameters were measured at Baseline (BL), Week 12 and Week 24. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose value at Week 24. Baseline was defined as the most recent individual value prior to randomization (generally Screening but could be a repeat test). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). The maximum post-Baseline values have also been presented.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=911 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=899 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Change From Baseline in Basophils, Eosinophils, Monocytes, Neutrophils, Leukocytes, Lymphocytes, and Platelets at Week 24
Week 24, Leukocytes, n=819,761
|
0.06 10^9 cells/Liter(L)
Standard Deviation 1.847
|
0.11 10^9 cells/Liter(L)
Standard Deviation 1.915
|
|
Change From Baseline in Basophils, Eosinophils, Monocytes, Neutrophils, Leukocytes, Lymphocytes, and Platelets at Week 24
Week 24, Basophils, n=817,761
|
-0.001 10^9 cells/Liter(L)
Standard Deviation 0.0217
|
-0.001 10^9 cells/Liter(L)
Standard Deviation 0.0204
|
|
Change From Baseline in Basophils, Eosinophils, Monocytes, Neutrophils, Leukocytes, Lymphocytes, and Platelets at Week 24
Maximum post BL, Basophils, n=876,853
|
0.005 10^9 cells/Liter(L)
Standard Deviation 0.0211
|
0.005 10^9 cells/Liter(L)
Standard Deviation 0.0206
|
|
Change From Baseline in Basophils, Eosinophils, Monocytes, Neutrophils, Leukocytes, Lymphocytes, and Platelets at Week 24
Week 24, Eosinophils, n=817, 761
|
-0.008 10^9 cells/Liter(L)
Standard Deviation 0.1926
|
-0.015 10^9 cells/Liter(L)
Standard Deviation 0.1926
|
|
Change From Baseline in Basophils, Eosinophils, Monocytes, Neutrophils, Leukocytes, Lymphocytes, and Platelets at Week 24
Maxmium post BL, Eosinophils, n=876,853
|
0.034 10^9 cells/Liter(L)
Standard Deviation 0.1941
|
0.019 10^9 cells/Liter(L)
Standard Deviation 0.1952
|
|
Change From Baseline in Basophils, Eosinophils, Monocytes, Neutrophils, Leukocytes, Lymphocytes, and Platelets at Week 24
Maximum post BL, Monocytes, n=876,853
|
0.040 10^9 cells/Liter(L)
Standard Deviation 0.1985
|
0.048 10^9 cells/Liter(L)
Standard Deviation 0.2069
|
|
Change From Baseline in Basophils, Eosinophils, Monocytes, Neutrophils, Leukocytes, Lymphocytes, and Platelets at Week 24
Maximum post BL, Leukocytes, n=877,853
|
0.52 10^9 cells/Liter(L)
Standard Deviation 1.940
|
0.64 10^9 cells/Liter(L)
Standard Deviation 1.947
|
|
Change From Baseline in Basophils, Eosinophils, Monocytes, Neutrophils, Leukocytes, Lymphocytes, and Platelets at Week 24
Week 24, Platelets, n=810,759
|
-0.7 10^9 cells/Liter(L)
Standard Deviation 43.12
|
-0.7 10^9 cells/Liter(L)
Standard Deviation 44.26
|
|
Change From Baseline in Basophils, Eosinophils, Monocytes, Neutrophils, Leukocytes, Lymphocytes, and Platelets at Week 24
Maximum post BL, Platelets, n=871,846
|
10.8 10^9 cells/Liter(L)
Standard Deviation 42.50
|
10.2 10^9 cells/Liter(L)
Standard Deviation 45.46
|
|
Change From Baseline in Basophils, Eosinophils, Monocytes, Neutrophils, Leukocytes, Lymphocytes, and Platelets at Week 24
Week 24, Lymphocytes, n=817,761
|
0.002 10^9 cells/Liter(L)
Standard Deviation 0.5311
|
-0.023 10^9 cells/Liter(L)
Standard Deviation 0.5669
|
|
Change From Baseline in Basophils, Eosinophils, Monocytes, Neutrophils, Leukocytes, Lymphocytes, and Platelets at Week 24
Maximum post BL, Lymphocytes, n=876,853
|
0.187 10^9 cells/Liter(L)
Standard Deviation 0.5468
|
0.150 10^9 cells/Liter(L)
Standard Deviation 0.5767
|
|
Change From Baseline in Basophils, Eosinophils, Monocytes, Neutrophils, Leukocytes, Lymphocytes, and Platelets at Week 24
Category title 5. Week 24, Monocytes, n=817,761
|
-0.006 10^9 cells/Liter(L)
Standard Deviation 0.1977
|
0.004 10^9 cells/Liter(L)
Standard Deviation 0.2125
|
|
Change From Baseline in Basophils, Eosinophils, Monocytes, Neutrophils, Leukocytes, Lymphocytes, and Platelets at Week 24
Week 24, Neutrophils, n=817,761
|
0.071 10^9 cells/Liter(L)
Standard Deviation 1.7682
|
0.142 10^9 cells/Liter(L)
Standard Deviation 1.8552
|
|
Change From Baseline in Basophils, Eosinophils, Monocytes, Neutrophils, Leukocytes, Lymphocytes, and Platelets at Week 24
Maximum post BL, Neutrophils, n=876,853
|
0.481 10^9 cells/Liter(L)
Standard Deviation 1.8761
|
0.649 10^9 cells/Liter(L)
Standard Deviation 1.9143
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Extension Population
Hematology laboratory assessments included Basophils, eosinophils, lymphocytes, monocytes,neutrophils, total neutrophil, leukocytes, and platelets; parameters were measured at Baseline (BL), Week 12, Week 24, and Week 52 for the extension part of the study. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose value at Week 52. Baseline was defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). The maximum post-Baseline values have also been presented.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=210 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=220 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Change From Baseline in Basophils, Eosinophils, Monocytes, Neutrophils, Leukocytes, Lymphocytes, and Platelets at Week 52
Week 52, Basophils, n=168,166
|
0.002 10^9 cells/L
Standard Deviation 0.0203
|
0.003 10^9 cells/L
Standard Deviation 0.0241
|
|
Change From Baseline in Basophils, Eosinophils, Monocytes, Neutrophils, Leukocytes, Lymphocytes, and Platelets at Week 52
Maximum post BL, Basophils, n=205,212
|
0.011 10^9 cells/L
Standard Deviation 0.0196
|
0.010 10^9 cells/L
Standard Deviation 0.0226
|
|
Change From Baseline in Basophils, Eosinophils, Monocytes, Neutrophils, Leukocytes, Lymphocytes, and Platelets at Week 52
Week 52, Eosinophils, n=168,166
|
0.002 10^9 cells/L
Standard Deviation 0.1819
|
-0.011 10^9 cells/L
Standard Deviation 0.2567
|
|
Change From Baseline in Basophils, Eosinophils, Monocytes, Neutrophils, Leukocytes, Lymphocytes, and Platelets at Week 52
Maximum post BL, Eosinophils, n=205,212
|
0.074 10^9 cells/L
Standard Deviation 0.2460
|
0.057 10^9 cells/L
Standard Deviation 0.2884
|
|
Change From Baseline in Basophils, Eosinophils, Monocytes, Neutrophils, Leukocytes, Lymphocytes, and Platelets at Week 52
Week 52, Monocytes, n=168,166
|
0.025 10^9 cells/L
Standard Deviation 0.2382
|
0.028 10^9 cells/L
Standard Deviation 0.2164
|
|
Change From Baseline in Basophils, Eosinophils, Monocytes, Neutrophils, Leukocytes, Lymphocytes, and Platelets at Week 52
Maximum post BL, Monocytes, n=205,212
|
0.075 10^9 cells/L
Standard Deviation 0.2359
|
0.072 10^9 cells/L
Standard Deviation 0.2123
|
|
Change From Baseline in Basophils, Eosinophils, Monocytes, Neutrophils, Leukocytes, Lymphocytes, and Platelets at Week 52
Week 52, Neutrophils, n=168,166
|
0.246 10^9 cells/L
Standard Deviation 2.1768
|
-0.163 10^9 cells/L
Standard Deviation 2.3222
|
|
Change From Baseline in Basophils, Eosinophils, Monocytes, Neutrophils, Leukocytes, Lymphocytes, and Platelets at Week 52
Maximum post BL, Neutrophils, n=205,212
|
0.923 10^9 cells/L
Standard Deviation 2.1444
|
0.835 10^9 cells/L
Standard Deviation 2.1223
|
|
Change From Baseline in Basophils, Eosinophils, Monocytes, Neutrophils, Leukocytes, Lymphocytes, and Platelets at Week 52
Week 52, Leukocytes, n=168,166
|
0.33 10^9 cells/L
Standard Deviation 2.243
|
-0.17 10^9 cells/L
Standard Deviation 2.387
|
|
Change From Baseline in Basophils, Eosinophils, Monocytes, Neutrophils, Leukocytes, Lymphocytes, and Platelets at Week 52
Maximum post BL, Leukocytes, n=205,212
|
0.97 10^9 cells/L
Standard Deviation 2.163
|
0.87 10^9 cells/L
Standard Deviation 2.168
|
|
Change From Baseline in Basophils, Eosinophils, Monocytes, Neutrophils, Leukocytes, Lymphocytes, and Platelets at Week 52
Week 52, Platelets, n=170,166
|
-1.8 10^9 cells/L
Standard Deviation 39.96
|
-2.7 10^9 cells/L
Standard Deviation 49.22
|
|
Change From Baseline in Basophils, Eosinophils, Monocytes, Neutrophils, Leukocytes, Lymphocytes, and Platelets at Week 52
Maximum post BL, Platelets, n=203,210
|
13.6 10^9 cells/L
Standard Deviation 40.57
|
13.9 10^9 cells/L
Standard Deviation 51.61
|
|
Change From Baseline in Basophils, Eosinophils, Monocytes, Neutrophils, Leukocytes, Lymphocytes, and Platelets at Week 52
Week 52, Lymphocytes, n=168,166
|
0.060 10^9 cells/L
Standard Deviation 0.6850
|
-0.027 10^9 cells/L
Standard Deviation 0.5714
|
|
Change From Baseline in Basophils, Eosinophils, Monocytes, Neutrophils, Leukocytes, Lymphocytes, and Platelets at Week 52
Maximum post BL, Lymphocytes, n=202,212
|
0.325 10^9 cells/L
Standard Deviation 0.6299
|
0.295 10^9 cells/L
Standard Deviation 0.5910
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: ITT Population
Hematology laboratory assessments included erythrocytes and was measured at Baseline, Week 12 and Week 24. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose value at Week 24. Baseline was defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). The maximum post-Baseline values have also been presented.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=911 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=899 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Change From Baseline in Erythrocytes at Week 24
Week 24, n=822,769
|
-0.02 10^12 cells/L
Standard Deviation 0.292
|
-0.04 10^12 cells/L
Standard Deviation 0.294
|
|
Change From Baseline in Erythrocytes at Week 24
Maximum post BL, n=880,857
|
0.06 10^12 cells/L
Standard Deviation 0.270
|
0.04 10^12 cells/L
Standard Deviation 0.273
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Extension Population
Hematology laboratory assessments included erythrocytes and was measured at Baseline, Week 12 and Week 24, and Week 52 for the extension part of the study. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose value at Week 52. Baseline was defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). The maximum post-Baseline values have also been presented.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=210 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=220 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Change From Baseline in Erythrocytes at Week 52
Week 52, n=174,170
|
0.02 10^12 cells/L
Standard Deviation 0.282
|
0.00 10^12 cells/L
Standard Deviation 0.313
|
|
Change From Baseline in Erythrocytes at Week 52
Maximum post BL, n=206,212
|
0.11 10^12 cells/L
Standard Deviation 0.261
|
0.07 10^12 cells/L
Standard Deviation 0.289
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: ITT Population
Blood samples were collected for the measurement of hemoglobin at Baseline, Week 12, and Week 24. Change from Baseline was calculated as the post-Baseline value at Week 24 minus the Baseline value. Baseline was defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). The maximum post-Baseline values have also been presented.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=911 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=899 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Change From Baseline in Hemoglobin at Week 24
Week 24, n=822,769
|
-0.9 Grams per liter (g/L)
Standard Deviation 8.17
|
-1.0 Grams per liter (g/L)
Standard Deviation 8.65
|
|
Change From Baseline in Hemoglobin at Week 24
Maximum post BL, n=880,857
|
1.5 Grams per liter (g/L)
Standard Deviation 7.55
|
1.5 Grams per liter (g/L)
Standard Deviation 8.26
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Extension Population
Blood samples were collected for the measurement of hemoglobin at Baseline, Week 12, Week 24, and Week 52 for the extension part of the study. Change from Baseline was calculated as the post-Baseline value at Week 52 minus the Baseline value. Baseline was defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). The maximum post-Baseline values have also been presented.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=210 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=220 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Change From Baseline in Hemoglobin at Week 52
Week 52, n=174,170
|
-2.5 g/L
Standard Deviation 8.06
|
-2.5 g/L
Standard Deviation 9.82
|
|
Change From Baseline in Hemoglobin at Week 52
Maximum post BL, n=206,212
|
2.2 g/L
Standard Deviation 7.67
|
1.9 g/L
Standard Deviation 8.55
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: ITT Population
Blood samples were collected for the measurement of hematocrit (proportion of red blood cells in blood) at Baseline, Week 12, and Week 24. Change from Baseline was calculated as the post-Baseline value at Week 24 minus the Baseline value. Baseline was defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). The maximum post-Baseline values have also been presented.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=911 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=899 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Change From Baseline in Hematocrit at Week 24
Week 24, n=822,769
|
0.0024 Fraction of 1
Standard Deviation 0.02627
|
0.0024 Fraction of 1
Standard Deviation 0.02798
|
|
Change From Baseline in Hematocrit at Week 24
Maximum post BL, n=880,857
|
0.0115 Fraction of 1
Standard Deviation 0.02533
|
0.0123 Fraction of 1
Standard Deviation 0.02669
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Extension Population
Blood samples were collected for the measurement of hematocrit (proportion of red blood cells in blood) at Baseline, Week 12, Week 24, and Week 52 for the extension part of the study. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as Most recent individual value prior to randomization (generally Screening but could be a test repeat). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). The maximum post-Baseline values have also been presented.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=210 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=220 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Change From Baseline in Hematocrit at Week 52
Week 52, n=174,170
|
-0.0056 Fraction of 1
Standard Deviation 0.02468
|
-0.0056 Fraction of 1
Standard Deviation 0.03170
|
|
Change From Baseline in Hematocrit at Week 52
Maximum post BL, n=206,212
|
0.0153 Fraction of 1
Standard Deviation 0.02552
|
0.0149 Fraction of 1
Standard Deviation 0.02793
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: ITT Population
Blood samples were collected for the measurement of albumin and protein at Baseline, Week 12 and Week 24. Change from Baseline (BL) was calculated as the post-Baseline value at Week 24 minus the Baseline value. Baseline was defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). The maximum post BL values have been presented. Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). The maximum post-Baseline values have also been presented.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=911 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=899 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Change From Baseline in Albumin and Protein at Week 24
Maximum post BL, Protein, n=888,866
|
0.4 g/L
Standard Deviation 3.42
|
0.1 g/L
Standard Deviation 3.43
|
|
Change From Baseline in Albumin and Protein at Week 24
Week 24, Albumin, n=839,787
|
-0.7 g/L
Standard Deviation 2.55
|
-0.5 g/L
Standard Deviation 2.41
|
|
Change From Baseline in Albumin and Protein at Week 24
Week 24, Protein, n=839,787
|
-0.6 g/L
Standard Deviation 3.70
|
-1.0 g/L
Standard Deviation 3.64
|
|
Change From Baseline in Albumin and Protein at Week 24
Maximum post BL, Albumin, n=888,866
|
0.1 g/L
Standard Deviation 2.36
|
0.2 g/L
Standard Deviation 2.24
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Extension Population
Blood samples were collected for the measurement of albumin and protein at Baseline, Week 12, Week 24, and Week 52 for the extension part of the study. Change from Baseline was calculated as the post-Baseline value at Week 52 minus the Baseline value. Baseline was defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). The maximum post-Baseline values have also been presented.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=210 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=220 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Change From Baseline in Albumin and Protein at Week 52
Week 52, Albumin, n=181,174
|
-0.8 g/L
Standard Deviation 2.77
|
-0.7 g/L
Standard Deviation 2.64
|
|
Change From Baseline in Albumin and Protein at Week 52
Week 52, Protein, n=181,174
|
-1.1 g/L
Standard Deviation 4.04
|
-1.6 g/L
Standard Deviation 3.86
|
|
Change From Baseline in Albumin and Protein at Week 52
Maximum post BL, Protein, n=207,214
|
0.6 g/L
Standard Deviation 3.57
|
0.0 g/L
Standard Deviation 3.30
|
|
Change From Baseline in Albumin and Protein at Week 52
Maximum post BL,Albumin, n=207,214
|
0.4 g/L
Standard Deviation 2.45
|
0.2 g/L
Standard Deviation 2.25
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: ITT Population
Blood samples were collected for the measurement of ALP, ALT, AST, CK, and GGT at Baseline, Week 12 and Week 24. Change from Baseline was calculated as the post-Baseline value at Week 24 minus the Baseline value. Baseline was defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). The maximum post-Baseline values have also been presented.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=911 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=899 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Aminotransferase (GGT), Alkaline Phosphatase (ALP), and Creatine Kinase at Week 24
Week 24, ALT, n=838,785
|
1.4 International units per liter (IU/L)
Standard Deviation 10.81
|
3.8 International units per liter (IU/L)
Standard Deviation 69.15
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Aminotransferase (GGT), Alkaline Phosphatase (ALP), and Creatine Kinase at Week 24
Maximum post BL, ALT, n=887,864
|
3.0 International units per liter (IU/L)
Standard Deviation 11.99
|
5.5 International units per liter (IU/L)
Standard Deviation 66.01
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Aminotransferase (GGT), Alkaline Phosphatase (ALP), and Creatine Kinase at Week 24
Week 24, AST, n=835,785
|
1.1 International units per liter (IU/L)
Standard Deviation 10.30
|
4.0 International units per liter (IU/L)
Standard Deviation 86.63
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Aminotransferase (GGT), Alkaline Phosphatase (ALP), and Creatine Kinase at Week 24
Maximum post BL, AST, n=887,866
|
3.2 International units per liter (IU/L)
Standard Deviation 12.61
|
5.6 International units per liter (IU/L)
Standard Deviation 82.66
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Aminotransferase (GGT), Alkaline Phosphatase (ALP), and Creatine Kinase at Week 24
Week 24, ALP, n=839,787
|
1.1 International units per liter (IU/L)
Standard Deviation 15.42
|
-2.8 International units per liter (IU/L)
Standard Deviation 12.47
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Aminotransferase (GGT), Alkaline Phosphatase (ALP), and Creatine Kinase at Week 24
Maximum post BL, ALP, n=888,866
|
4.3 International units per liter (IU/L)
Standard Deviation 16.46
|
0.8 International units per liter (IU/L)
Standard Deviation 11.96
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Aminotransferase (GGT), Alkaline Phosphatase (ALP), and Creatine Kinase at Week 24
Week 24, GGT, n=839,787
|
3.4 International units per liter (IU/L)
Standard Deviation 31.65
|
0.5 International units per liter (IU/L)
Standard Deviation 21.84
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Aminotransferase (GGT), Alkaline Phosphatase (ALP), and Creatine Kinase at Week 24
Maximum post BL, GGT, n=888,866
|
7.5 International units per liter (IU/L)
Standard Deviation 42.66
|
4.7 International units per liter (IU/L)
Standard Deviation 27.76
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Aminotransferase (GGT), Alkaline Phosphatase (ALP), and Creatine Kinase at Week 24
Week 24, Creatine Kinase, n=839,787
|
-3.9 International units per liter (IU/L)
Standard Deviation 106.48
|
-3.4 International units per liter (IU/L)
Standard Deviation 191.25
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Aminotransferase (GGT), Alkaline Phosphatase (ALP), and Creatine Kinase at Week 24
Maximum post BL, Creatine Kinase, n=888,866
|
20.6 International units per liter (IU/L)
Standard Deviation 138.17
|
20.6 International units per liter (IU/L)
Standard Deviation 185.06
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Extension Population
Blood samples were collected for the measurement of ALP, ALT, AST, CK, and GGT at Baseline, Week 12, Week 24 and Week 52 for the extension part of the study. Change from Baseline was calculated as the post-Baseline value at Week 52 minus the Baseline value. Baseline was defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). The maximum post-Baseline values have also been presented.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=210 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=220 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Change From Baseline in ALT, AST, GGT, ALP, and Creatine Kinase at Week 52
Week 52, ALT, n=181,173
|
1.7 International units per liter (IU/L)
Standard Deviation 10.64
|
1.3 International units per liter (IU/L)
Standard Deviation 12.38
|
|
Change From Baseline in ALT, AST, GGT, ALP, and Creatine Kinase at Week 52
Week 52, AST, n=180,174
|
1.7 International units per liter (IU/L)
Standard Deviation 9.72
|
0.8 International units per liter (IU/L)
Standard Deviation 11.16
|
|
Change From Baseline in ALT, AST, GGT, ALP, and Creatine Kinase at Week 52
Maximum post BL, AST, n=207,214
|
5.5 International units per liter (IU/L)
Standard Deviation 15.55
|
3.7 International units per liter (IU/L)
Standard Deviation 11.65
|
|
Change From Baseline in ALT, AST, GGT, ALP, and Creatine Kinase at Week 52
Week 52, ALP, n=181,174
|
1.7 International units per liter (IU/L)
Standard Deviation 13.77
|
-2.7 International units per liter (IU/L)
Standard Deviation 10.83
|
|
Change From Baseline in ALT, AST, GGT, ALP, and Creatine Kinase at Week 52
Maximum post BL, Creatine Kinase, n=207,214
|
39.9 International units per liter (IU/L)
Standard Deviation 79.71
|
46.9 International units per liter (IU/L)
Standard Deviation 90.78
|
|
Change From Baseline in ALT, AST, GGT, ALP, and Creatine Kinase at Week 52
Maximum post BL, ALT, n=207,212
|
5.4 International units per liter (IU/L)
Standard Deviation 15.45
|
4.5 International units per liter (IU/L)
Standard Deviation 12.84
|
|
Change From Baseline in ALT, AST, GGT, ALP, and Creatine Kinase at Week 52
Maximum post BL, ALP, n=207,214
|
6.7 International units per liter (IU/L)
Standard Deviation 12.84
|
1.2 International units per liter (IU/L)
Standard Deviation 11.73
|
|
Change From Baseline in ALT, AST, GGT, ALP, and Creatine Kinase at Week 52
Week 52, GGT, n=181,174
|
0.2 International units per liter (IU/L)
Standard Deviation 28.77
|
0.2 International units per liter (IU/L)
Standard Deviation 26.86
|
|
Change From Baseline in ALT, AST, GGT, ALP, and Creatine Kinase at Week 52
Maximum post BL, GGT, n=207,214
|
7.7 International units per liter (IU/L)
Standard Deviation 31.33
|
8.9 International units per liter (IU/L)
Standard Deviation 34.98
|
|
Change From Baseline in ALT, AST, GGT, ALP, and Creatine Kinase at Week 52
Week 52, Creatine Kinase, n=181,174
|
6.1 International units per liter (IU/L)
Standard Deviation 68.48
|
16.7 International units per liter (IU/L)
Standard Deviation 97.17
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: ITT Population
Blood samples were collected for the measurement of Glucose, calcium, CO2, chloride, phophate, potassium, sodium, and urea at Baseline, Week 12, and Week 24. Change from Baseline was calculated as the post-Baseline value at Week 24 minus the Baseline value. Baseline was defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). The maximum post-Baseline values have also been presented.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=911 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=899 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Change From Baseline in Glucose, Calcium, Carbon Dioxide (CO2), Chloride, Phosphate, Potassium, Sodium, and Urea at Week 24
Week 24, CO2, n=835,785
|
-0.6 Millimoles per liter (mmol/L)
Standard Deviation 2.54
|
-0.0 Millimoles per liter (mmol/L)
Standard Deviation 2.61
|
|
Change From Baseline in Glucose, Calcium, Carbon Dioxide (CO2), Chloride, Phosphate, Potassium, Sodium, and Urea at Week 24
Maximum post BL, CO2, n=835,785
|
0.0 Millimoles per liter (mmol/L)
Standard Deviation 2.38
|
0.5 Millimoles per liter (mmol/L)
Standard Deviation 2.48
|
|
Change From Baseline in Glucose, Calcium, Carbon Dioxide (CO2), Chloride, Phosphate, Potassium, Sodium, and Urea at Week 24
Week 24, Glucose, n=839,787
|
0.12 Millimoles per liter (mmol/L)
Standard Deviation 1.433
|
-0.00 Millimoles per liter (mmol/L)
Standard Deviation 1.449
|
|
Change From Baseline in Glucose, Calcium, Carbon Dioxide (CO2), Chloride, Phosphate, Potassium, Sodium, and Urea at Week 24
Maximum post BL, Glucose, n=887,866
|
0.53 Millimoles per liter (mmol/L)
Standard Deviation 1.506
|
0.37 Millimoles per liter (mmol/L)
Standard Deviation 1.463
|
|
Change From Baseline in Glucose, Calcium, Carbon Dioxide (CO2), Chloride, Phosphate, Potassium, Sodium, and Urea at Week 24
Week 24, Potassium, n=834,785
|
0.04 Millimoles per liter (mmol/L)
Standard Deviation 0.457
|
-0.03 Millimoles per liter (mmol/L)
Standard Deviation 0.456
|
|
Change From Baseline in Glucose, Calcium, Carbon Dioxide (CO2), Chloride, Phosphate, Potassium, Sodium, and Urea at Week 24
Maximum post BL, Potassium, n=887,866
|
0.18 Millimoles per liter (mmol/L)
Standard Deviation 0.428
|
0.13 Millimoles per liter (mmol/L)
Standard Deviation 0.417
|
|
Change From Baseline in Glucose, Calcium, Carbon Dioxide (CO2), Chloride, Phosphate, Potassium, Sodium, and Urea at Week 24
Maximum post BL, Phosphate, n=888,866
|
0.039 Millimoles per liter (mmol/L)
Standard Deviation 0.2310
|
0.043 Millimoles per liter (mmol/L)
Standard Deviation 0.2576
|
|
Change From Baseline in Glucose, Calcium, Carbon Dioxide (CO2), Chloride, Phosphate, Potassium, Sodium, and Urea at Week 24
Maximum post BL, Sodium, n=888,866
|
0.6 Millimoles per liter (mmol/L)
Standard Deviation 2.15
|
0.7 Millimoles per liter (mmol/L)
Standard Deviation 2.22
|
|
Change From Baseline in Glucose, Calcium, Carbon Dioxide (CO2), Chloride, Phosphate, Potassium, Sodium, and Urea at Week 24
Week 24, Urea, n=839,787
|
0.08 Millimoles per liter (mmol/L)
Standard Deviation 1.591
|
0.04 Millimoles per liter (mmol/L)
Standard Deviation 1.549
|
|
Change From Baseline in Glucose, Calcium, Carbon Dioxide (CO2), Chloride, Phosphate, Potassium, Sodium, and Urea at Week 24
Maximum post BL, Urea, n=888,866
|
0.68 Millimoles per liter (mmol/L)
Standard Deviation 1.601
|
0.64 Millimoles per liter (mmol/L)
Standard Deviation 1.604
|
|
Change From Baseline in Glucose, Calcium, Carbon Dioxide (CO2), Chloride, Phosphate, Potassium, Sodium, and Urea at Week 24
Week 24, Calcium, n=835,785
|
-0.016 Millimoles per liter (mmol/L)
Standard Deviation 0.0887
|
-0.014 Millimoles per liter (mmol/L)
Standard Deviation 0.0931
|
|
Change From Baseline in Glucose, Calcium, Carbon Dioxide (CO2), Chloride, Phosphate, Potassium, Sodium, and Urea at Week 24
Maximum post BL, Calcium, n=887,866
|
0.013 Millimoles per liter (mmol/L)
Standard Deviation 0.0817
|
0.012 Millimoles per liter (mmol/L)
Standard Deviation 0.0868
|
|
Change From Baseline in Glucose, Calcium, Carbon Dioxide (CO2), Chloride, Phosphate, Potassium, Sodium, and Urea at Week 24
Week 24, Chloride, n=838,787
|
-0.4 Millimoles per liter (mmol/L)
Standard Deviation 2.76
|
-0.7 Millimoles per liter (mmol/L)
Standard Deviation 2.60
|
|
Change From Baseline in Glucose, Calcium, Carbon Dioxide (CO2), Chloride, Phosphate, Potassium, Sodium, and Urea at Week 24
Maximum post BL, Chloride, n=888,866
|
0.9 Millimoles per liter (mmol/L)
Standard Deviation 2.53
|
0.6 Millimoles per liter (mmol/L)
Standard Deviation 2.35
|
|
Change From Baseline in Glucose, Calcium, Carbon Dioxide (CO2), Chloride, Phosphate, Potassium, Sodium, and Urea at Week 24
Week 24, Phosphate, n=839,787
|
-0.028 Millimoles per liter (mmol/L)
Standard Deviation 0.2373
|
-0.029 Millimoles per liter (mmol/L)
Standard Deviation 0.2728
|
|
Change From Baseline in Glucose, Calcium, Carbon Dioxide (CO2), Chloride, Phosphate, Potassium, Sodium, and Urea at Week 24
Week 24, Sodium, n=837,787
|
-0.3 Millimoles per liter (mmol/L)
Standard Deviation 2.35
|
-0.2 Millimoles per liter (mmol/L)
Standard Deviation 2.38
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Extension Population
Blood samples were collected for the measurement of Glucose, calcium, CO2, chloride, magnesium, phophate, potassium, sodium, and urea at Baseline, Week 12, Week 24, and Week 52 for the extension part of the study. Change from Baseline was calculated as the post-Baseline value at Week 52 minus the Baseline value. Baseline was defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). The maximum post-Baseline values have also been presented.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=210 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=220 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Change From Baseline in Glucose, Calcium, CO2, Chloride, Magnesium, Phosphate, Potassium, Sodium, and Urea at Week 52
Week 52, Calcium, n=180,174
|
-0.033 Mmol/L
Standard Deviation 0.0943
|
-0.040 Mmol/L
Standard Deviation 0.0968
|
|
Change From Baseline in Glucose, Calcium, CO2, Chloride, Magnesium, Phosphate, Potassium, Sodium, and Urea at Week 52
Maximum post BL,Chloride, n=207,214
|
1.4 Mmol/L
Standard Deviation 2.63
|
1.3 Mmol/L
Standard Deviation 2.39
|
|
Change From Baseline in Glucose, Calcium, CO2, Chloride, Magnesium, Phosphate, Potassium, Sodium, and Urea at Week 52
Week 52, CO2, n=180,174
|
-1.2 Mmol/L
Standard Deviation 2.46
|
-1.0 Mmol/L
Standard Deviation 2.58
|
|
Change From Baseline in Glucose, Calcium, CO2, Chloride, Magnesium, Phosphate, Potassium, Sodium, and Urea at Week 52
Maximum post BL,CO2, n=207,214
|
-0.2 Mmol/L
Standard Deviation 2.26
|
0.3 Mmol/L
Standard Deviation 2.28
|
|
Change From Baseline in Glucose, Calcium, CO2, Chloride, Magnesium, Phosphate, Potassium, Sodium, and Urea at Week 52
Week 52, Glucose, n=181,174
|
0.31 Mmol/L
Standard Deviation 1.538
|
0.22 Mmol/L
Standard Deviation 1.546
|
|
Change From Baseline in Glucose, Calcium, CO2, Chloride, Magnesium, Phosphate, Potassium, Sodium, and Urea at Week 52
Maximum post BL,Glucose, n=207,214
|
0.92 Mmol/L
Standard Deviation 1.683
|
0.63 Mmol/L
Standard Deviation 1.738
|
|
Change From Baseline in Glucose, Calcium, CO2, Chloride, Magnesium, Phosphate, Potassium, Sodium, and Urea at Week 52
Week 52, Potassium, n=180,174
|
-0.02 Mmol/L
Standard Deviation 0.443
|
-0.10 Mmol/L
Standard Deviation 0.454
|
|
Change From Baseline in Glucose, Calcium, CO2, Chloride, Magnesium, Phosphate, Potassium, Sodium, and Urea at Week 52
Maximum post BL,Potassium, n=207,214
|
0.29 Mmol/L
Standard Deviation 0.456
|
0.20 Mmol/L
Standard Deviation 0.418
|
|
Change From Baseline in Glucose, Calcium, CO2, Chloride, Magnesium, Phosphate, Potassium, Sodium, and Urea at Week 52
Week 52, Phosphate, n=181,174
|
-0.003 Mmol/L
Standard Deviation 0.1645
|
0.005 Mmol/L
Standard Deviation 0.1800
|
|
Change From Baseline in Glucose, Calcium, CO2, Chloride, Magnesium, Phosphate, Potassium, Sodium, and Urea at Week 52
Maximum post BL,Phosphate, n=207,214
|
0.109 Mmol/L
Standard Deviation 0.1551
|
0.110 Mmol/L
Standard Deviation 0.1770
|
|
Change From Baseline in Glucose, Calcium, CO2, Chloride, Magnesium, Phosphate, Potassium, Sodium, and Urea at Week 52
Week 52, Sodium, n=181,174
|
-0.2 Mmol/L
Standard Deviation 2.34
|
-0.1 Mmol/L
Standard Deviation 2.51
|
|
Change From Baseline in Glucose, Calcium, CO2, Chloride, Magnesium, Phosphate, Potassium, Sodium, and Urea at Week 52
Maximum post BL,Sodium, n=207,214
|
1.1 Mmol/L
Standard Deviation 2.13
|
1.1 Mmol/L
Standard Deviation 2.22
|
|
Change From Baseline in Glucose, Calcium, CO2, Chloride, Magnesium, Phosphate, Potassium, Sodium, and Urea at Week 52
Week 52, Urea, n=181,174
|
0.16 Mmol/L
Standard Deviation 1.625
|
0.12 Mmol/L
Standard Deviation 1.553
|
|
Change From Baseline in Glucose, Calcium, CO2, Chloride, Magnesium, Phosphate, Potassium, Sodium, and Urea at Week 52
Maximum post BL, Urea, n=207,214
|
1.06 Mmol/L
Standard Deviation 1.755
|
1.08 Mmol/L
Standard Deviation 1.629
|
|
Change From Baseline in Glucose, Calcium, CO2, Chloride, Magnesium, Phosphate, Potassium, Sodium, and Urea at Week 52
Maximum post BL,Calcium, n=207,214
|
0.026 Mmol/L
Standard Deviation 0.0849
|
0.008 Mmol/L
Standard Deviation 0.0868
|
|
Change From Baseline in Glucose, Calcium, CO2, Chloride, Magnesium, Phosphate, Potassium, Sodium, and Urea at Week 52
Week 52, Chloride, n=181,174
|
-0.1 Mmol/L
Standard Deviation 3.00
|
-0.2 Mmol/L
Standard Deviation 2.71
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: ITT Population
Blood samples were collected for the measurement of bilirubin, creatinine, and urate at Baseline, Week 12, and Week 24. Change from Baseline was calculated as the post-Baseline value at Week 24 minus the Baseline value. Baseline was defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). The maximum post-Baseline values have also been presented.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=911 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=899 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Change From Baseline in Bilirubin, Creatinine, and Urate at Week 24
Maximum post BL, Bilirubin, n=888,865
|
1.1 Micromoles per liter
Standard Deviation 4.09
|
1.2 Micromoles per liter
Standard Deviation 3.67
|
|
Change From Baseline in Bilirubin, Creatinine, and Urate at Week 24
Week 24, Creatinine, n=839,787
|
1.05 Micromoles per liter
Standard Deviation 9.816
|
1.14 Micromoles per liter
Standard Deviation 9.580
|
|
Change From Baseline in Bilirubin, Creatinine, and Urate at Week 24
Maximum post BL, Creatinine, n=888,866
|
4.12 Micromoles per liter
Standard Deviation 9.711
|
3.99 Micromoles per liter
Standard Deviation 9.509
|
|
Change From Baseline in Bilirubin, Creatinine, and Urate at Week 24
Week 24, Urate, n=839,787
|
2.8 Micromoles per liter
Standard Deviation 60.87
|
1.7 Micromoles per liter
Standard Deviation 62.96
|
|
Change From Baseline in Bilirubin, Creatinine, and Urate at Week 24
Maximum post BL, Urate, n=888,866
|
23.7 Micromoles per liter
Standard Deviation 58.64
|
21.9 Micromoles per liter
Standard Deviation 59.20
|
|
Change From Baseline in Bilirubin, Creatinine, and Urate at Week 24
Week 24, Bilirubin, n=839,786
|
-0.2 Micromoles per liter
Standard Deviation 3.88
|
0.1 Micromoles per liter
Standard Deviation 3.77
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Extension Population
Blood samples were collected for the measurement of bilirubin, creatinine, and urate at Baseline, Week 12, Week 24, and Week 52 of the extension part of the study. Change from Baseline was calculated as the post-Baseline value at Week 52 minus the Baseline value. Baseline was defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat).
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=210 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=220 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Change From Baseline in Bilirubin, Creatinine, and Urate at Week 52
Week 52, Bilirubin, n=181,174
|
0.3 Micromoles per liter
Standard Deviation 3.41
|
0.1 Micromoles per liter
Standard Deviation 3.94
|
|
Change From Baseline in Bilirubin, Creatinine, and Urate at Week 52
Maximum post BL, Bilirubin, n=207,214
|
2.0 Micromoles per liter
Standard Deviation 3.88
|
2.3 Micromoles per liter
Standard Deviation 4.28
|
|
Change From Baseline in Bilirubin, Creatinine, and Urate at Week 52
Week 52, Creatinine, n=181,174
|
2.95 Micromoles per liter
Standard Deviation 11.663
|
1.28 Micromoles per liter
Standard Deviation 11.563
|
|
Change From Baseline in Bilirubin, Creatinine, and Urate at Week 52
Maximum post BL, Creatinine, n=207,214
|
6.99 Micromoles per liter
Standard Deviation 11.425
|
6.00 Micromoles per liter
Standard Deviation 11.392
|
|
Change From Baseline in Bilirubin, Creatinine, and Urate at Week 52
Week 52, Urate, n=181,174
|
3.6 Micromoles per liter
Standard Deviation 60.92
|
3.9 Micromoles per liter
Standard Deviation 64.85
|
|
Change From Baseline in Bilirubin, Creatinine, and Urate at Week 52
Maximum post BL, Urate, n=207,214
|
42.0 Micromoles per liter
Standard Deviation 62.06
|
40.0 Micromoles per liter
Standard Deviation 63.47
|
SECONDARY outcome
Timeframe: Up to Week 24Population: ITT Population
Oropharyngeal examinations for clinical evidence of infection (e.g., Candida albicans) were performed at each clinic visit. All suspected cases of candidiasis were reported as AEs. The number of participants with oral candidiasis, Candida infection, oral fungal infection, and oropharyngeal candidiasis were reported.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=911 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=899 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Number of Participants Reporting an Adverse Event of Special Interest (AESI) of Oropharyngeal Origin in the Treatment Period
Oral candidiasis
|
2 Participants
|
4 Participants
|
|
Number of Participants Reporting an Adverse Event of Special Interest (AESI) of Oropharyngeal Origin in the Treatment Period
Candida infection
|
1 Participants
|
4 Participants
|
|
Number of Participants Reporting an Adverse Event of Special Interest (AESI) of Oropharyngeal Origin in the Treatment Period
Oral fungal infection
|
2 Participants
|
3 Participants
|
|
Number of Participants Reporting an Adverse Event of Special Interest (AESI) of Oropharyngeal Origin in the Treatment Period
Oropharyngeal candidiasis
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 52Population: Extension Population
Oropharyngeal examinations for clinical evidence of infection (e.g., Candida albicans) were performed at each clinic visit. All suspected cases of candidiasis were reported as AEs. The number of participants with oral candidiasis, candida infection, oral fungal infection, and oropharyngeal candidiasis were reported.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=210 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=220 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Number of Participants Reporting an AESI of Oropharyngeal Origin in the Extension Part of the Study
Candida infection
|
0 Participants
|
3 Participants
|
|
Number of Participants Reporting an AESI of Oropharyngeal Origin in the Extension Part of the Study
Oral fungal infection
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to Week 24Population: ITT Population
To evaluate the potential for bone systemic corticosteroid effects, the incidence of bone fractures was assessed. It was categorized as an adverse event of special interest.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=911 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=899 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Number of Participants With at Least One On-treatment Bone Fracture Incident in the Treatment Period
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to Week 52Population: Extension Population
To evaluate the potential for bone systemic corticosteroid effects, the incidence of bone fractures was assessed. It was categorized as an adverse event of special interest.
Outcome measures
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=210 Participants
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=220 Participants
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Number of Participants With at Least One On-treatment Bone Fracture Incident in the Extension Part of the Study
|
0 Participants
|
1 Participants
|
Adverse Events
FF/UMEC/VI 100/62.5/25 µg
Serious events: 61 serious events
Other events: 105 other events
Deaths: 0 deaths
BUD/FOR 400/12 µg
Serious events: 64 serious events
Other events: 104 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=911 participants at risk
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=899 participants at risk
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Cardiac disorders
Acute coronory syndrome
|
0.11%
1/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.00%
0/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Cardiac disorders
Acute myocardial infarction
|
0.11%
1/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.11%
1/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Cardiac disorders
Angina pectoris
|
0.11%
1/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.11%
1/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Cardiac disorders
Atrial fibrillation
|
0.11%
1/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.11%
1/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.11%
1/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Cardiac disorders
Atrioventricular block complete
|
0.11%
1/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.00%
0/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Cardiac disorders
Cardiac failure
|
0.11%
1/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.22%
2/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.11%
1/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Cardiac disorders
Cyanosis
|
0.00%
0/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.11%
1/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.22%
2/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Cardiac disorders
Myocaridal ischemia
|
0.00%
0/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.11%
1/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.11%
1/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Eye disorders
Cataract
|
0.00%
0/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.11%
1/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Gastrointestinal disorders
Constipation
|
0.22%
2/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.00%
0/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.11%
1/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.11%
1/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Gastrointestinal disorders
Intestinal mass
|
0.11%
1/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.00%
0/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.11%
1/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
General disorders
Catheter site phlebitis
|
0.00%
0/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.11%
1/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.11%
1/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
General disorders
Sudden cardiac death
|
0.22%
2/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.00%
0/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.11%
1/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.00%
0/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Infections and infestations
Appendicitis
|
0.11%
1/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.00%
0/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Infections and infestations
Cellulitis
|
0.00%
0/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.11%
1/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Infections and infestations
Infected dermal cyst
|
0.11%
1/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.00%
0/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Infections and infestations
Infective exacerbation of chronic onstructive airways diseas
|
0.00%
0/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.11%
1/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Infections and infestations
Lung infection
|
0.11%
1/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.00%
0/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Infections and infestations
Osteomyelitis
|
0.11%
1/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.00%
0/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Infections and infestations
Pneumonia
|
1.1%
10/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.56%
5/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.11%
1/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Infections and infestations
Sepsis
|
0.00%
0/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.11%
1/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Infections and infestations
Tuberculosis
|
0.11%
1/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.00%
0/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Infections and infestations
Urinary tract infection
|
0.11%
1/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.00%
0/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.22%
2/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.00%
0/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.11%
1/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.00%
0/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.11%
1/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.11%
1/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.00%
0/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Injury, poisoning and procedural complications
Procedural hemorrhage
|
0.11%
1/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.00%
0/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.11%
1/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Investigations
Electrocardiogram ST segment elevation
|
0.11%
1/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.00%
0/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Musculoskeletal and connective tissue disorders
Intervertebra; disc protrusion
|
0.11%
1/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.00%
0/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.11%
1/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.00%
0/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.11%
1/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.00%
0/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.11%
1/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brian neoplasm malignant
|
0.00%
0/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.11%
1/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.11%
1/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.00%
0/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.11%
1/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.11%
1/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.22%
2/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.11%
1/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.00%
0/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.11%
1/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.00%
0/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.11%
1/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.00%
0/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.11%
1/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.00%
0/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.11%
1/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.11%
1/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Nervous system disorders
Hemorrhagic stroke
|
0.11%
1/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.00%
0/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Nervous system disorders
Ischemic stroke
|
0.11%
1/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.00%
0/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Nervous system disorders
Postical paralysis
|
0.00%
0/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.11%
1/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Nervous system disorders
Presyncope
|
0.00%
0/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.11%
1/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Nervous system disorders
Transient ischemic stroke
|
0.11%
1/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.11%
1/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Psychiatric disorders
Anxiety
|
0.11%
1/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.00%
0/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Psychiatric disorders
Psychotic disorder
|
0.11%
1/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.00%
0/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Renal and urinary disorders
Chronic kideny disease
|
0.00%
0/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.11%
1/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Renal and urinary disorders
Hemorrhage urinary tract
|
0.11%
1/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.00%
0/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.11%
1/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.11%
1/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary edema
|
0.00%
0/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.11%
1/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.8%
16/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
3.4%
31/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.00%
0/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.11%
1/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.00%
0/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.11%
1/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.11%
1/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.11%
1/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.11%
1/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.00%
0/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.11%
1/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.11%
1/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.00%
0/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Surgical and medical procedures
Heart valve replacement
|
0.11%
1/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.00%
0/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.11%
1/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.00%
0/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.11%
1/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
0.00%
0/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
Other adverse events
| Measure |
FF/UMEC/VI 100/62.5/25 µg
n=911 participants at risk
Participants received FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA dry powder inhaler (DPI) once daily in the morning and placebo via the Turbuhaler twice daily (BID) for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
BUD/FOR 400/12 µg
n=899 participants at risk
Participants received BUD/FOR 400/12 µg via the Turbuhaler BID and placebo via the ELLIPTA once daily in the morning for 24 weeks in the treatment period and 52 weeks for participants in the extension part of the study.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
7.9%
72/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
5.7%
51/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
|
Nervous system disorders
Headache
|
4.8%
44/911 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
6.2%
56/899 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of the study drug until Week 24 and follow-up period for participants in ITT population and up to Week 52 and follow-up for participants in Extension Population
On-treatment SAEs and non-serious AEs are reported for ITT and extension populations
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
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