Trial Outcomes & Findings for Cross-Over Study in Subjects With COPD, Evaluating Lung Function Response After Treatment With Once Daily Umeclidinium 62.5mcg, Vilanterol 25mcg, and Umeclidinium/Vilanterol 62.5/25mcg (NCT NCT01716520)
NCT ID: NCT01716520
Last Updated: 2017-01-09
Results Overview
FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM FEV1 was calculated using 0-6 hour post-dose measurements at Day 14 of each TP, which included pre-dose (trough value for Day 14 \[mean of the 23 and 24 hour assessments post Day 13 dosing\]) and post-dose 15 minutes (min), 30 min, and 1, 3, and 6 hours. BL is the mean FEV1 values recorded 30 min and 5 min pre-dose on Day 1 of each TP, mean BL is the mean of the BLs for each participant, and period BL is the difference between the BL and the mean BL in each TP for each participant. Change from BL for each TP is the Day 14 value minus the BL value for that TP. Participants could have been classified as responders to both UMEC and VI.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
182 participants
Primary outcome timeframe
Baseline and Day 14 of each treatment period (up to study day 83)
Results posted on
2017-01-09
Participant Flow
Participants who met the eligibility criteria at screening (Visit 1) completed a 5- to 7-day run-in period prior to being randomized to 1 of 6 treatment sequences. The treatment phase was comprised of three 14-day treatment periods, each separated by a 10- to 14-day washout period, starting on Day 15.
Participant milestones
| Measure |
Sequence 1: UMEC 62.5 µg, VI 25 µg, UMEC/VI 62.5/25 µg
Participants received umeclidinium (UMEC) 62.5 micrograms (µg), vilanterol (VI) 25 µg, and UMEC/VI 62.5/25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day (QD) for 14 days from a Dry Powder Inhaler (DPI). The three treatment periods were separated by a washout period of 10 to 14 days.
|
Sequence 2: VI 25 µg, UMEC/VI 62.5/25 µg, UMEC 62.5 µg
Participants received VI 25 µg, UMEC/VI 62.5/25 µg, and UMEC 62.5 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
|
Sequence 3: UMEC/VI 62.5/25 µg, UMEC 62.5 µg, VI 25 µg
Participants received UMEC/VI 62.5/25 µg, UMEC 62.5 µg, and VI 25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
|
Sequence 4: UMEC 62.5 µg, UMEC/VI 62.5/25 µg, VI 25 µg
Participants received UMEC 62.5 µg, UMEC/VI 62.5/25 µg, and VI 25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
|
Sequence 5: VI 25 µg, UMEC 62.5 µg, UMEC/VI 62.5/25 µg
Participants received VI 25 µg, UMEC 62.5 µg, and UMEC/VI 62.5/25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
|
Sequence 6: UMEC/VI 62.5/25 µg, VI 25 µg, UMEC 62.5 µg
Participants received UMEC/VI 62.5/25 µg, VI 25 µg, and UMEC 62.5 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
|
|---|---|---|---|---|---|---|
|
Treatment Period 1 (14 Days)
STARTED
|
31
|
30
|
30
|
30
|
31
|
30
|
|
Treatment Period 1 (14 Days)
COMPLETED
|
29
|
29
|
28
|
29
|
31
|
29
|
|
Treatment Period 1 (14 Days)
NOT COMPLETED
|
2
|
1
|
2
|
1
|
0
|
1
|
|
Washout Period 1 (10 to 14 Days)
STARTED
|
29
|
29
|
28
|
29
|
31
|
29
|
|
Washout Period 1 (10 to 14 Days)
COMPLETED
|
29
|
28
|
27
|
29
|
31
|
27
|
|
Washout Period 1 (10 to 14 Days)
NOT COMPLETED
|
0
|
1
|
1
|
0
|
0
|
2
|
|
Treatment Period 2 (14 Days)
STARTED
|
29
|
28
|
27
|
29
|
31
|
27
|
|
Treatment Period 2 (14 Days)
COMPLETED
|
29
|
28
|
27
|
28
|
29
|
27
|
|
Treatment Period 2 (14 Days)
NOT COMPLETED
|
0
|
0
|
0
|
1
|
2
|
0
|
|
Washout Period 2 (10 to 14 Days)
STARTED
|
29
|
28
|
27
|
28
|
29
|
27
|
|
Washout Period 2 (10 to 14 Days)
COMPLETED
|
27
|
27
|
26
|
28
|
29
|
25
|
|
Washout Period 2 (10 to 14 Days)
NOT COMPLETED
|
2
|
1
|
1
|
0
|
0
|
2
|
|
Treatment Period 3 (14 Days)
STARTED
|
27
|
27
|
26
|
28
|
29
|
25
|
|
Treatment Period 3 (14 Days)
COMPLETED
|
27
|
27
|
25
|
28
|
29
|
23
|
|
Treatment Period 3 (14 Days)
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Sequence 1: UMEC 62.5 µg, VI 25 µg, UMEC/VI 62.5/25 µg
Participants received umeclidinium (UMEC) 62.5 micrograms (µg), vilanterol (VI) 25 µg, and UMEC/VI 62.5/25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day (QD) for 14 days from a Dry Powder Inhaler (DPI). The three treatment periods were separated by a washout period of 10 to 14 days.
|
Sequence 2: VI 25 µg, UMEC/VI 62.5/25 µg, UMEC 62.5 µg
Participants received VI 25 µg, UMEC/VI 62.5/25 µg, and UMEC 62.5 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
|
Sequence 3: UMEC/VI 62.5/25 µg, UMEC 62.5 µg, VI 25 µg
Participants received UMEC/VI 62.5/25 µg, UMEC 62.5 µg, and VI 25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
|
Sequence 4: UMEC 62.5 µg, UMEC/VI 62.5/25 µg, VI 25 µg
Participants received UMEC 62.5 µg, UMEC/VI 62.5/25 µg, and VI 25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
|
Sequence 5: VI 25 µg, UMEC 62.5 µg, UMEC/VI 62.5/25 µg
Participants received VI 25 µg, UMEC 62.5 µg, and UMEC/VI 62.5/25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
|
Sequence 6: UMEC/VI 62.5/25 µg, VI 25 µg, UMEC 62.5 µg
Participants received UMEC/VI 62.5/25 µg, VI 25 µg, and UMEC 62.5 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
|
|---|---|---|---|---|---|---|
|
Treatment Period 1 (14 Days)
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 1 (14 Days)
Protocol-defined Stopping Criteria
|
1
|
0
|
2
|
1
|
0
|
1
|
|
Treatment Period 1 (14 Days)
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Washout Period 1 (10 to 14 Days)
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Washout Period 1 (10 to 14 Days)
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Washout Period 1 (10 to 14 Days)
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
1
|
|
Treatment Period 2 (14 Days)
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Treatment Period 2 (14 Days)
Protocol Violation
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Treatment Period 2 (14 Days)
Protocol-defined Stopping Criteria
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Washout Period 2 (10 to 14 Days)
Adverse Event
|
1
|
0
|
1
|
0
|
0
|
1
|
|
Washout Period 2 (10 to 14 Days)
Lack of Efficacy
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period 2 (10 to 14 Days)
Protocol-defined Stopping Criteria
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Washout Period 2 (10 to 14 Days)
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Treatment Period 3 (14 Days)
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Treatment Period 3 (14 Days)
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Cross-Over Study in Subjects With COPD, Evaluating Lung Function Response After Treatment With Once Daily Umeclidinium 62.5mcg, Vilanterol 25mcg, and Umeclidinium/Vilanterol 62.5/25mcg
Baseline characteristics by cohort
| Measure |
UMEC 62.5 µg, VI 25 µg, UMEC/VI 62.5/25 µg
n=182 Participants
All participants received one of the following three treatments in one of three treatment periods QD from the DPI for 14 days: UMEC 62.5 µg inhalation powder; VI 25 µg inhalation powder; and UMEC/VI 62.5/25 µg inhalation powder. Participants were randomized to receive treatment in one of the six following sequences: (1) UMEC 62.5 µg, VI 25 µg, UMEC/VI 62.5/25 µg; (2) VI 25 µg, UMEC/VI 62.5/25 µg, UMEC 62.5 µg; (3) UMEC/VI 62.5/25 µg, UMEC 62.5 µg, VI 25 µg; (4) UMEC 62.5 µg, UMEC/VI 62.5/25 µg, VI 25 µg; (5) VI 25 µg, UMEC 62.5 µg, UMEC/VI 62.5/25 µg; (6) UMEC/VI 62.5/25 µg, VI 25 µg, UMEC 62.5 µg. The three treatment periods were separated by a washout period of 10 to 14 days.
|
|---|---|
|
Age, Continuous
|
63.2 Years
STANDARD_DEVIATION 8.19 • n=5 Participants
|
|
Gender
Female
|
55 Participants
n=5 Participants
|
|
Gender
Male
|
127 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
182 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 14 of each treatment period (up to study day 83)Population: Intent-to-Treat (ITT) Population: all participants (par.) randomized to treatment who received \>=1 dose of randomized study medication in a TP. Only par. available at the specified time points were analyzed. Different par. may have been analyzed for different parameters; the overall number of par, analyzed reflects everyone in the ITT Population.
FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM FEV1 was calculated using 0-6 hour post-dose measurements at Day 14 of each TP, which included pre-dose (trough value for Day 14 \[mean of the 23 and 24 hour assessments post Day 13 dosing\]) and post-dose 15 minutes (min), 30 min, and 1, 3, and 6 hours. BL is the mean FEV1 values recorded 30 min and 5 min pre-dose on Day 1 of each TP, mean BL is the mean of the BLs for each participant, and period BL is the difference between the BL and the mean BL in each TP for each participant. Change from BL for each TP is the Day 14 value minus the BL value for that TP. Participants could have been classified as responders to both UMEC and VI.
Outcome measures
| Measure |
UMEC 62.5 µg
n=171 Participants
Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
|
VI 25 µg
n=171 Participants
Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
|
UMEC/VI 62.5/25 µg
n=173 Participants
Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
|
|---|---|---|---|
|
Change From Baseline (BL) in Weighted Mean (WM) 0-6 Hour Forced Expiratory Volume in One Second (FEV1) Obtained Post-dose at Day 14 of Each Treatment Period (TP) by Response Type
Responder to UMEC, n=90, 90, 88
|
0.216 Liters
Standard Error 0.0166
|
0.201 Liters
Standard Error 0.0167
|
0.337 Liters
Standard Error 0.0166
|
|
Change From Baseline (BL) in Weighted Mean (WM) 0-6 Hour Forced Expiratory Volume in One Second (FEV1) Obtained Post-dose at Day 14 of Each Treatment Period (TP) by Response Type
Responder to VI, n=99, 102, 100
|
0.189 Liters
Standard Error 0.0150
|
0.233 Liters
Standard Error 0.0147
|
0.331 Liters
Standard Error 0.0148
|
|
Change From Baseline (BL) in Weighted Mean (WM) 0-6 Hour Forced Expiratory Volume in One Second (FEV1) Obtained Post-dose at Day 14 of Each Treatment Period (TP) by Response Type
Responder to Neither, n=36, 37, 36
|
0.077 Liters
Standard Error 0.0243
|
0.057 Liters
Standard Error 0.0240
|
0.130 Liters
Standard Error 0.0243
|
SECONDARY outcome
Timeframe: Baseline (BL) and 0-6 hours post-dose (15 minutes, 30 minutes, and 1, 3, and 6 hours post-dose) on Day 1 of each treatment period (up to study day 71)Population: ITT Population
A responder is a par. with an increase from BL of \>=12% and 200 milliliters (mL) at \>=1 time point over 0-6 hours post-dose (PD) in FEV1 on Day 1. A non-responder (NR) is a par. with \>=1 FEV1 assessment over 0-6 hours PD on Day 1 but no increase from BL of \>=12% and 200 mL at any assessment(s). Missing: no FEV1 data recorded over 0-6 hours PD on Day 1. Response type is defined based on a par.'s response to each individual monotherapy treatment. A responder to UMEC is a par. who is a responder in the UMEC treatment period (TP) and either a NR or has missing data in the VI TP. A responder to VI is a par. who is a responder in the VI TP and either a NR or has missing data in the UMEC TP. A responder to UMEC and VI is a par. who is a responder in both the UMEC and VI TPs. A responder to neither is a par. who is a NR in both the UMEC and VI TPs. Missing: a par. who has missing data in both the UMEC and VI TPs, or who has missing data in one monotherapy period and is a NR in the other.
Outcome measures
| Measure |
UMEC 62.5 µg
n=171 Participants
Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
|
VI 25 µg
n=171 Participants
Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
|
UMEC/VI 62.5/25 µg
n=173 Participants
Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
|
|---|---|---|---|
|
Number of Participants (Par.) Who Were Responsive to UMEC/VI, UMEC, or VI According to FEV1 at Day 1 of Each Treatment Period (TP)
Responders
|
92 participants
|
104 participants
|
124 participants
|
|
Number of Participants (Par.) Who Were Responsive to UMEC/VI, UMEC, or VI According to FEV1 at Day 1 of Each Treatment Period (TP)
Non-responders
|
79 participants
|
67 participants
|
49 participants
|
SECONDARY outcome
Timeframe: Baseline and Day 14 of each treatment period (up to study day 83)Population: ITT Population. Only those participants available at the specified time point were analyzed.
The number of participants with a larger change from Baseline in weighted mean FEV1 with UMEC/VI compared with UMEC and VI alone was recorded. Participants who improved on UMEC/VI had a larger change from Baseline difference in 0-6 hour weighted mean FEV1 on Day 14 on UMEC/VI compared to UMEC or VI alone. Baseline is the mean FEV1 values recorded 30 min and 5 min pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Change from Baseline for each treatment period is the Day 14 value minus the Baseline value for that treatment period.
Outcome measures
| Measure |
UMEC 62.5 µg
n=162 Participants
Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
|
VI 25 µg
n=163 Participants
Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
|
UMEC/VI 62.5/25 µg
Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
|
|---|---|---|---|
|
Number of Participants With a Larger Change From Baseline in 0-6 Hour Weighted Mean FEV1 at Day 14 of Each Treatment Period With UMEC/VI Compared With UMEC and VI Alone
Not Improved on UMEC/VI
|
49 participants
|
42 participants
|
—
|
|
Number of Participants With a Larger Change From Baseline in 0-6 Hour Weighted Mean FEV1 at Day 14 of Each Treatment Period With UMEC/VI Compared With UMEC and VI Alone
Improved on UMEC/VI
|
113 participants
|
121 participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and Day 15 of each treatment period (up to study day 84)Population: ITT Population. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed for different parameters; the overall number of participants analyzed reflects everyone in the ITT Population.
Trough FEV1 on Treatment Day 15 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after dosing on Day 14. Analysis was performed using an ANCOVA model with covariates of treatment, period, mean Baseline (BL), period BL, response type, and treatment by response type interaction. A participant is a reponder to UMEC if they were a responder to UMEC monotherapy or a responder to both UMEC monotherapy and VI monotherapy. A participant is a responder to VI if they were a responder to VI monotherapy or a responder to both UMEC monotherapy or VI monotherapy. BL is the mean FEV1 recorded 30 min and 5 min pre-dose on Day 1 of each treatment period, mean BL is the mean of the BLs for each participant, and period BL is the difference between BL and the mean BL in each treatment period for each participant. Change from BL for each treatment period is the Day 15 value minus the BL value for that treatment period.
Outcome measures
| Measure |
UMEC 62.5 µg
n=171 Participants
Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
|
VI 25 µg
n=171 Participants
Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
|
UMEC/VI 62.5/25 µg
n=173 Participants
Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
|
|---|---|---|---|
|
Change From Baseline in Trough FEV1 on Day 15 of Each Treatment Period
Responder to UMEC, n=90, 89, 87
|
0.159 Liters
Standard Error 0.0178
|
0.134 Liters
Standard Error 0.0180
|
0.242 Liters
Standard Error 0.0179
|
|
Change From Baseline in Trough FEV1 on Day 15 of Each Treatment Period
Responder to VI, n=99, 101, 99
|
0.135 Liters
Standard Error 0.0160
|
0.161 Liters
Standard Error 0.0158
|
0.268 Liters
Standard Error 0.0159
|
|
Change From Baseline in Trough FEV1 on Day 15 of Each Treatment Period
Responder to Neither, n=35, 37, 36
|
0.060 Liters
Standard Error 0.0263
|
0.035 Liters
Standard Error 0.0257
|
0.092 Liters
Standard Error 0.0260
|
Adverse Events
UMEC 62.5 µg
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
VI 25 µg
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
UMEC/VI 62.5/25 µg
Serious events: 3 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
UMEC 62.5 µg
n=171 participants at risk
Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
|
VI 25 µg
n=171 participants at risk
Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
|
UMEC/VI 62.5/25 µg
n=173 participants at risk
Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Study Week 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
0.00%
0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Study Week 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
0.58%
1/173 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Study Week 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.58%
1/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Study Week 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
0.00%
0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Study Week 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
0.00%
0/173 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Study Week 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.58%
1/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Study Week 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
0.00%
0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Study Week 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
0.00%
0/173 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Study Week 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.2%
2/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Study Week 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
0.00%
0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Study Week 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
0.00%
0/173 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Study Week 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Study Week 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
0.00%
0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Study Week 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
0.58%
1/173 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Study Week 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Study Week 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
0.00%
0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Study Week 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
0.58%
1/173 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Study Week 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Study Week 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
0.58%
1/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Study Week 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
0.00%
0/173 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Study Week 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
Other adverse events
| Measure |
UMEC 62.5 µg
n=171 participants at risk
Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
|
VI 25 µg
n=171 participants at risk
Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
|
UMEC/VI 62.5/25 µg
n=173 participants at risk
Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
2.9%
5/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Study Week 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
6.4%
11/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Study Week 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
4.0%
7/173 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Study Week 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
|
Nervous system disorders
Headache
|
1.8%
3/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Study Week 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
1.2%
2/171 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Study Week 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
3.5%
6/173 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Study Week 12).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
|
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