Trial Outcomes & Findings for A Cross-Over Study to Evaluate Lung Function Response After Treatment With Umeclidinium (UMEC) 62.5 Micrograms (mcg), Vilanterol (VI) 25 mcg, and Umeclidinium/Vilanterol (UMEC/VI) 62.5/25 mcg Once-Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT02014480)
NCT ID: NCT02014480
Last Updated: 2018-02-15
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.
COMPLETED
PHASE3
207 participants
Baseline and Day 14 of each treatment period (up to study day 85)
2018-02-15
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.
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 trifenatate (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
|
35
|
35
|
34
|
34
|
35
|
34
|
|
Treatment Period 1 (14 Days)
COMPLETED
|
35
|
34
|
33
|
32
|
34
|
34
|
|
Treatment Period 1 (14 Days)
NOT COMPLETED
|
0
|
1
|
1
|
2
|
1
|
0
|
|
Washout Period 1 (10 to 14 Days)
STARTED
|
35
|
34
|
33
|
32
|
34
|
34
|
|
Washout Period 1 (10 to 14 Days)
COMPLETED
|
35
|
34
|
32
|
32
|
34
|
34
|
|
Washout Period 1 (10 to 14 Days)
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Treatment Period 2 (14 Days)
STARTED
|
35
|
34
|
32
|
32
|
34
|
34
|
|
Treatment Period 2 (14 Days)
COMPLETED
|
34
|
33
|
30
|
31
|
34
|
34
|
|
Treatment Period 2 (14 Days)
NOT COMPLETED
|
1
|
1
|
2
|
1
|
0
|
0
|
|
Washout Period 2 (10 to 14 Days)
STARTED
|
34
|
33
|
30
|
31
|
34
|
34
|
|
Washout Period 2 (10 to 14 Days)
COMPLETED
|
34
|
33
|
30
|
31
|
34
|
34
|
|
Washout Period 2 (10 to 14 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 3 (14 Days)
STARTED
|
34
|
33
|
30
|
31
|
34
|
34
|
|
Treatment Period 3 (14 Days)
COMPLETED
|
34
|
32
|
29
|
31
|
34
|
32
|
|
Treatment Period 3 (14 Days)
NOT COMPLETED
|
0
|
1
|
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 trifenatate (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)
Lack of Efficacy
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Treatment Period 1 (14 Days)
Withdrawal by Subject
|
0
|
1
|
0
|
2
|
1
|
0
|
|
Washout Period 1 (10 to 14 Days)
Lack of Efficacy
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Treatment Period 2 (14 Days)
Protocol Violation
|
1
|
1
|
2
|
1
|
0
|
0
|
|
Treatment Period 3 (14 Days)
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Treatment Period 3 (14 Days)
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
1
|
|
Treatment Period 3 (14 Days)
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Cross-Over Study to Evaluate Lung Function Response After Treatment With Umeclidinium (UMEC) 62.5 Micrograms (mcg), Vilanterol (VI) 25 mcg, and Umeclidinium/Vilanterol (UMEC/VI) 62.5/25 mcg Once-Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Baseline characteristics by cohort
| Measure |
UMEC 62.5 µg, VI 25 µg, UMEC/VI 62.5/25 µg
n=207 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
|
60.5 Years
STANDARD_DEVIATION 7.99 • n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
169 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
207 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 14 of each treatment period (up to study day 85)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.
Outcome measures
| Measure |
UMEC 62.5 µg
n=202 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=200 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=202 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 VI, n=78, 77, 80
|
0.135 Liters
Standard Error 0.0182
|
0.182 Liters
Standard Error 0.0183
|
0.264 Liters
Standard Error 0.0180
|
|
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=79, 78, 81
|
0.155 Liters
Standard Error 0.0184
|
0.156 Liters
Standard Error 0.0185
|
0.263 Liters
Standard Error 0.0179
|
|
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=80, 79, 80
|
0.014 Liters
Standard Error 0.0179
|
0.035 Liters
Standard Error 0.0180
|
0.092 Liters
Standard Error 0.0179
|
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 66)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=202 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=200 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=202 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)
Non-responder
|
121 participants
|
119 participants
|
99 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)
Responder
|
81 participants
|
81 participants
|
103 participants
|
SECONDARY outcome
Timeframe: Baseline and Day 14 of each treatment period (up to study day 85)Population: ITT Population. Only those participants available at the indicated time point were assessed.
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=193 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=192 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
Improved on UMEC/VI
|
124 participants
|
130 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
Not improved on UMEC/VI
|
69 participants
|
62 participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and Day 15 of each treatment period (up to study day 81)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=202 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=200 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=202 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 Clinic Visit Pre-dose Trough FEV1 at Day 15 of Each Treatment Period
Responder to UMEC, n=79, 78, 80
|
0.105 Liters
Standard Error 0.0196
|
0.086 Liters
Standard Error 0.0197
|
0.170 Liters
Standard Error 0.0191
|
|
Change From Baseline in Clinic Visit Pre-dose Trough FEV1 at Day 15 of Each Treatment Period
Responder to VI, n=78, 78, 80
|
0.088 Liters
Standard Error 0.0194
|
0.106 Liters
Standard Error 0.0193
|
0.166 Liters
Standard Error 0.0191
|
|
Change From Baseline in Clinic Visit Pre-dose Trough FEV1 at Day 15 of Each Treatment Period
Responder to Neither, n=80, 79, 79
|
0.016 Liters
Standard Error 0.0190
|
0.004 Liters
Standard Error 0.0191
|
0.062 Liters
Standard Error 0.0191
|
Adverse Events
UMEC 62.5 µg
VI 25 µg
UMEC/VI 62.5/25 µg
Serious adverse events
| Measure |
UMEC 62.5 µg
n=202 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=200 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=202 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
Gastroenteritis
|
0.00%
0/202 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of treatment (up to Week 24).
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%
0/200 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of treatment (up to Week 24).
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.
|
0.50%
1/202 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of treatment (up to Week 24).
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
Orchitis
|
0.50%
1/202 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of treatment (up to Week 24).
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%
0/200 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of treatment (up to Week 24).
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%
0/202 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of treatment (up to Week 24).
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)
Squamous cell carcinoma
|
0.00%
0/202 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of treatment (up to Week 24).
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.
|
0.50%
1/200 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of treatment (up to Week 24).
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%
0/202 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of treatment (up to Week 24).
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=202 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=200 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=202 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.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
2.5%
5/202 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of treatment (up to Week 24).
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.
|
5.0%
10/200 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of treatment (up to Week 24).
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.
|
5.0%
10/202 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of treatment (up to Week 24).
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.
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Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER