Trial Outcomes & Findings for A Randomized, Double Blind, Placebo Controlled, Incomplete Block, Crossover, Dose Ranging Study to Evaluate the Dose Response of GSK573719 Administered Once or Twice Daily Over 7 Days in Patients With Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT01372410)
NCT ID: NCT01372410
Last Updated: 2017-11-08
Results Overview
The trough FEV1 data for both the once-daily (QD) and twice-daily (BID) UMEC doses were included in a parametric analysis in order to evaluate trough FEV1dose response. The Day 8 dataset and a pooled dataset for Day 7 and Day 8 were analyzed separately and reported. The rationale for pooling Day 7 and Day 8 (post-hoc analysis) was to ensure informative interpretation of FEV1 response as a function of dose given the repeated measures for trough FEV1 response within each participant on different days. The fixed-effects parameters of the dose response model include Emax (the maximum predicted FEV1 response), ED50 (potency), and S0 (estimated Baseline FEV1). FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Data for Emax and S0 are reported in this table. mITT=Modified Intent-to-Treat; par.=participants; BL=Baseline.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
163 participants
Primary outcome timeframe
Day 7 and Day 8 of each treatment period (up to Study Day 50)
Results posted on
2017-11-08
Participant Flow
Participants were randomized to receive a sequence of 3 of 8 possible treatments over 3 treatment periods. There are 56 combinations of 3 treatments from the 8 study treatments, each of which can be ordered in 6 ways (totaling 336 possible sequences; 163 were randomly assigned). Participant Flow data are presented by treatment rather than sequence.
Participant milestones
| Measure |
Placebo
Participants received matching placebo once in the morning and once in the evening for 7 days via a dry powder inhaler (DPI) in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 15.6 µg QD
Participants received an inhaled dose of a dry powder formulation of umeclidinium bromide (UMEC) 15.6 micrograms (µg) once a day (QD) for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 31.25 µg QD
Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 62.5 µg QD
Participants received an inhaled dose of a dry powder formulation of UMEC 62.5 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 125 µg QD
Participants received an inhaled dose of a dry powder formulation of UMEC 125 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 15.6 µg BID
Participants received an inhaled dose of a dry powder formulation of UMEC 15.6 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 31.25 µg BID
Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
TIO 18 µg QD
Participants received tiotropium bromide (TIO) 18 µg inhalation capsules via the HandiHaler dry powder inhaler for 7 days in the morning and placebo via the DPI in the evening in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
|---|---|---|---|---|---|---|---|---|
|
Treatment Period 1 (7 Days)
STARTED
|
20
|
21
|
19
|
20
|
21
|
21
|
22
|
19
|
|
Treatment Period 1 (7 Days)
COMPLETED
|
19
|
19
|
19
|
20
|
19
|
21
|
20
|
19
|
|
Treatment Period 1 (7 Days)
NOT COMPLETED
|
1
|
2
|
0
|
0
|
2
|
0
|
2
|
0
|
|
Washout Period 1 (10-14 Days)
STARTED
|
19
|
19
|
19
|
20
|
19
|
21
|
20
|
19
|
|
Washout Period 1 (10-14 Days)
COMPLETED
|
18
|
19
|
19
|
20
|
19
|
21
|
20
|
18
|
|
Washout Period 1 (10-14 Days)
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Treatment Period 2 (7 Days)
STARTED
|
19
|
21
|
22
|
17
|
19
|
16
|
21
|
19
|
|
Treatment Period 2 (7 Days)
COMPLETED
|
19
|
21
|
22
|
17
|
19
|
16
|
21
|
19
|
|
Treatment Period 2 (7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period 2 (10-14 Days)
STARTED
|
19
|
21
|
22
|
17
|
19
|
16
|
21
|
19
|
|
Washout Period 2 (10-14 Days)
COMPLETED
|
19
|
21
|
22
|
17
|
17
|
16
|
20
|
17
|
|
Washout Period 2 (10-14 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
2
|
0
|
1
|
2
|
|
Treatment Period 3 (7 Days)
STARTED
|
21
|
18
|
16
|
22
|
20
|
19
|
15
|
18
|
|
Treatment Period 3 (7 Days)
COMPLETED
|
21
|
18
|
15
|
22
|
20
|
18
|
15
|
18
|
|
Treatment Period 3 (7 Days)
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Participants received matching placebo once in the morning and once in the evening for 7 days via a dry powder inhaler (DPI) in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 15.6 µg QD
Participants received an inhaled dose of a dry powder formulation of umeclidinium bromide (UMEC) 15.6 micrograms (µg) once a day (QD) for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 31.25 µg QD
Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 62.5 µg QD
Participants received an inhaled dose of a dry powder formulation of UMEC 62.5 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 125 µg QD
Participants received an inhaled dose of a dry powder formulation of UMEC 125 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 15.6 µg BID
Participants received an inhaled dose of a dry powder formulation of UMEC 15.6 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 31.25 µg BID
Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
TIO 18 µg QD
Participants received tiotropium bromide (TIO) 18 µg inhalation capsules via the HandiHaler dry powder inhaler for 7 days in the morning and placebo via the DPI in the evening in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
|---|---|---|---|---|---|---|---|---|
|
Treatment Period 1 (7 Days)
Lack of Efficacy
|
1
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Treatment Period 1 (7 Days)
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Treatment Period 1 (7 Days)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Treatment Period 1 (7 Days)
Participant Withdrew Consent
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Washout Period 1 (10-14 Days)
Participant Withdrew Consent
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Washout Period 2 (10-14 Days)
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Washout Period 2 (10-14 Days)
Participant Withdrew Consent
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
1
|
|
Washout Period 2 (10-14 Days)
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Treatment Period 3 (7 Days)
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 3 (7 Days)
Protocol Deviation
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Randomized, Double Blind, Placebo Controlled, Incomplete Block, Crossover, Dose Ranging Study to Evaluate the Dose Response of GSK573719 Administered Once or Twice Daily Over 7 Days in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Baseline characteristics by cohort
| Measure |
All Study Treatments
n=163 Participants
Participants received a sequence containing 3 of the following 8 possible treatments: placebo; UMEC 15.6 µg, 31.25 µg, 62.5 µg, and 125 µg QD; UMEC 15.6 µg and 31.25 µg BID; TIO 18 µg QD. Participants received each of the treatments in 1 of 3 7-day treatment periods, each of which was followed by a Washout Period. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
|---|---|
|
Age, Continuous
|
59.5 Years
STANDARD_DEVIATION 9.21 • n=93 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
16 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
145 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
1 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Day 7 and Day 8 of each treatment period (up to Study Day 50)Population: mITT Population: par. randomized to treatment who received \>=1 dose of study medication. Par. with \>=1 post-BL assessment and non-missing covariate data are included in the analysis. Different par. may have been analyzed at different time points (n=X in category titles); the overall number of par. analyzed reflects everyone in the mITT Population.
The trough FEV1 data for both the once-daily (QD) and twice-daily (BID) UMEC doses were included in a parametric analysis in order to evaluate trough FEV1dose response. The Day 8 dataset and a pooled dataset for Day 7 and Day 8 were analyzed separately and reported. The rationale for pooling Day 7 and Day 8 (post-hoc analysis) was to ensure informative interpretation of FEV1 response as a function of dose given the repeated measures for trough FEV1 response within each participant on different days. The fixed-effects parameters of the dose response model include Emax (the maximum predicted FEV1 response), ED50 (potency), and S0 (estimated Baseline FEV1). FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Data for Emax and S0 are reported in this table. mITT=Modified Intent-to-Treat; par.=participants; BL=Baseline.
Outcome measures
| Measure |
All Study Treatments
n=163 Participants
Participants received a sequence containing 3 of the following 8 possible treatments: placebo; UMEC 15.6 µg, 31.25 µg, 62.5 µg, and 125 µg QD; UMEC 15.6 µg and 31.25 µg BID; TIO 18 µg QD. Participants received each of the treatments in 1 of 3 7-day treatment periods, each of which was followed by a Washout Period. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 15.6 µg QD
Participants received an inhaled dose of a dry powder formulation of umeclidinium bromide (UMEC) 15.6 micrograms (µg) once a day (QD) for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 31.25 µg QD
Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 62.5 µg QD
Participants received an inhaled dose of a dry powder formulation of UMEC 62.5 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 125 µg QD
Participants received an inhaled dose of a dry powder formulation of UMEC 125 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 15.6 µg BID
Participants received an inhaled dose of a dry powder formulation of UMEC 15.6 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 31.25 µg BID
Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
TIO 18 µg QD
Participants received tiotropium bromide (TIO) 18 µg inhalation capsules via the HandiHaler dry powder inhaler for 7 days in the morning and placebo via the DPI in the evening in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
|---|---|---|---|---|---|---|---|---|
|
Final Dose-response Model for Trough Forced Expiratory Volume in One Second (FEV1)
Day 8, Emax, n=157
|
0.185 Liters
Interval 0.154 to 0.216
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Final Dose-response Model for Trough Forced Expiratory Volume in One Second (FEV1)
Pooled Day 7 and Day 8, Emax, n=160
|
0.156 Liters
Interval 0.123 to 0.189
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Final Dose-response Model for Trough Forced Expiratory Volume in One Second (FEV1)
Day 8, S0, n=157
|
1.24 Liters
Interval 1.21 to 1.27
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Final Dose-response Model for Trough Forced Expiratory Volume in One Second (FEV1)
Pooled Day 7 and 8, S0, n=160
|
1.24 Liters
Interval 1.21 to 1.27
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 7 and Day 8 of each treatment period (up to Study Day 50)Population: mITT Population: par. randomized to treatment who received \>=1 dose of study medication. Par. with \>=1 post-BL assessment and non-missing covariate data are included in the analysis. Different par. may have been analyzed at different time points (n=X in category titles); the overall number of par. analyzed reflects everyone in the mITT Population.
The trough FEV1 data for both the once-daily (QD) and twice-daily (BID) UMEC doses were included in a parametric analysis in order to evaluate dose response. Both a Day 8 dataset and a pooled dataset for Day 7 and Day 8 were analyzed and reported. The rationale for pooling Day 7 and Day 8 (post-hoc analysis) was to ensure informative interpretation of FEV1 response as a function of dose given the repeated measures for trough FEV1 response within each participant on different days. ED50 is defined as the potency and is the dose that yields 50% of Emax (maximum predicted FEV1 response). FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second.
Outcome measures
| Measure |
All Study Treatments
n=163 Participants
Participants received a sequence containing 3 of the following 8 possible treatments: placebo; UMEC 15.6 µg, 31.25 µg, 62.5 µg, and 125 µg QD; UMEC 15.6 µg and 31.25 µg BID; TIO 18 µg QD. Participants received each of the treatments in 1 of 3 7-day treatment periods, each of which was followed by a Washout Period. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 15.6 µg QD
Participants received an inhaled dose of a dry powder formulation of umeclidinium bromide (UMEC) 15.6 micrograms (µg) once a day (QD) for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 31.25 µg QD
Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 62.5 µg QD
Participants received an inhaled dose of a dry powder formulation of UMEC 62.5 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 125 µg QD
Participants received an inhaled dose of a dry powder formulation of UMEC 125 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 15.6 µg BID
Participants received an inhaled dose of a dry powder formulation of UMEC 15.6 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 31.25 µg BID
Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
TIO 18 µg QD
Participants received tiotropium bromide (TIO) 18 µg inhalation capsules via the HandiHaler dry powder inhaler for 7 days in the morning and placebo via the DPI in the evening in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
|---|---|---|---|---|---|---|---|---|
|
Final Dose-response Model for Trough FEV1 for ED50 (Potency) Parameter
Day 8, ED50, n=157
|
37.4 micrograms
Interval 17.8 to 57.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Final Dose-response Model for Trough FEV1 for ED50 (Potency) Parameter
Pooled Day 7 and Day 8, ED50, n=160
|
38.2 micrograms
Interval 14.7 to 61.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 7 and Day 8 of each treatment period (up to Study Day 50)Population: mITT Population: par. randomized to treatment who received \>=1 dose of study medication. Par. with \>=1 post-BL assessment and non-missing covariate data are included in the analysis. Different par. may have been analyzed at different time points (n=X in category titles); the overall number of par. analyzed reflects everyone in the mITT Population.
The trough FEV1 data for both the once-daily (QD) and twice-daily (BID) UMEC doses were included in a parametric analysis in order to evaluate dose response. Both a Day 8 dataset and a pooled dataset for Day 7 and Day 8 were analyzed and reported. The rationale for pooling Day 7 and Day 8 (post-hoc analysis) was to ensure informative interpretation of FEV1 response as a function of dose given the repeated measures for trough FEV1 response within each participant on different days. β-FEV1MB-S0 is defined as the covariate (Baseline trough FEV1) effect on the mean Baseline trough FEV1 estimate (S0). FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second.
Outcome measures
| Measure |
All Study Treatments
n=163 Participants
Participants received a sequence containing 3 of the following 8 possible treatments: placebo; UMEC 15.6 µg, 31.25 µg, 62.5 µg, and 125 µg QD; UMEC 15.6 µg and 31.25 µg BID; TIO 18 µg QD. Participants received each of the treatments in 1 of 3 7-day treatment periods, each of which was followed by a Washout Period. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 15.6 µg QD
Participants received an inhaled dose of a dry powder formulation of umeclidinium bromide (UMEC) 15.6 micrograms (µg) once a day (QD) for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 31.25 µg QD
Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 62.5 µg QD
Participants received an inhaled dose of a dry powder formulation of UMEC 62.5 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 125 µg QD
Participants received an inhaled dose of a dry powder formulation of UMEC 125 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 15.6 µg BID
Participants received an inhaled dose of a dry powder formulation of UMEC 15.6 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 31.25 µg BID
Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
TIO 18 µg QD
Participants received tiotropium bromide (TIO) 18 µg inhalation capsules via the HandiHaler dry powder inhaler for 7 days in the morning and placebo via the DPI in the evening in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
|---|---|---|---|---|---|---|---|---|
|
Final Dose-response Model Parameter β-FEV1MB-S0 for Trough FEV1
Day 8, βFEV1MB-S0, n=157
|
0.691 fraction of mean estimated Baseline FEV1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Final Dose-response Model Parameter β-FEV1MB-S0 for Trough FEV1
Pooled Day 7 and 8, βFEV1MB-S0, n=160
|
0.686 fraction of mean estimated Baseline FEV1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and Day 8 of each treatment period (up to Study Day 50)Population: mITT Population. All participants with \>=1 post-baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 8.
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 on Treatment Day 8 is defined as the value obtained 24 hours after the morning dose administered on Day 7. Analysis was performed using a mixed model with covariates of mean Baseline, period Baseline, treatment, and period as fixed effects and participant as a random effect. Baseline is the FEV1 value recorded 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 particiapant. Change from Baseline for each treatment period is the trough FEV1 at Day 8 minus the Baseline value for that treatment period.
Outcome measures
| Measure |
All Study Treatments
n=59 Participants
Participants received a sequence containing 3 of the following 8 possible treatments: placebo; UMEC 15.6 µg, 31.25 µg, 62.5 µg, and 125 µg QD; UMEC 15.6 µg and 31.25 µg BID; TIO 18 µg QD. Participants received each of the treatments in 1 of 3 7-day treatment periods, each of which was followed by a Washout Period. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 15.6 µg QD
n=58 Participants
Participants received an inhaled dose of a dry powder formulation of umeclidinium bromide (UMEC) 15.6 micrograms (µg) once a day (QD) for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 31.25 µg QD
n=56 Participants
Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 62.5 µg QD
n=59 Participants
Participants received an inhaled dose of a dry powder formulation of UMEC 62.5 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 125 µg QD
n=59 Participants
Participants received an inhaled dose of a dry powder formulation of UMEC 125 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 15.6 µg BID
n=55 Participants
Participants received an inhaled dose of a dry powder formulation of UMEC 15.6 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 31.25 µg BID
n=57 Participants
Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
TIO 18 µg QD
n=56 Participants
Participants received tiotropium bromide (TIO) 18 µg inhalation capsules via the HandiHaler dry powder inhaler for 7 days in the morning and placebo via the DPI in the evening in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 8 of Each Treatment Period
|
-0.074 Liters
Standard Error 0.022
|
0.038 Liters
Standard Error 0.022
|
0.027 Liters
Standard Error 0.023
|
0.049 Liters
Standard Error 0.022
|
0.109 Liters
Standard Error 0.022
|
0.051 Liters
Standard Error 0.023
|
0.065 Liters
Standard Error 0.023
|
0.027 Liters
Standard Error 0.023
|
SECONDARY outcome
Timeframe: Baseline and Day 7 of each treatment period (TP; up to Study Day 49)Population: mITT Population. All participants (par.) with \>=1 post-BL assessment and non-missing covariate data are included in the analysis. Different par. may have been analyzed at different time points (n=X, X, X, X in the category titles), so the overall number of par. analyzed reflects everyone in the mITT Population with data available at \>=1 time point.
Serial FEV1 for once daily dosing is recorded at the pre-AM dose (AMD; time 0 hour \[h\]) and at 1, 3, 6, 9, 12,13, 15, 23, and 24 hours after the AMD on Day 7. For twice daily dosing, the 12 h AMD corresponds to the pre-PM dose (PMD), the 13 h AMD corresponds to the 1 h PMD, the 15 h AMD corresponds to the 3 h PMD, the 23 h AMD corresponds to the 11 h PMD, and the 24 h AMD corresponds to the 12 h PMD in this table. Analysis was performed using a mixed model with covariates of mean BL, period BL, treatment, period, time, time by period BL interaction, time by mean BL interaction, and time by treatment interaction as fixed effects and participant as a random effect. BL is the value recorded pre-dose on Day 1 of each TP, mean BLis 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 timepoint within a TP is the serial FEV1 measure at that timepoint minus the BL value for that TP.
Outcome measures
| Measure |
All Study Treatments
n=60 Participants
Participants received a sequence containing 3 of the following 8 possible treatments: placebo; UMEC 15.6 µg, 31.25 µg, 62.5 µg, and 125 µg QD; UMEC 15.6 µg and 31.25 µg BID; TIO 18 µg QD. Participants received each of the treatments in 1 of 3 7-day treatment periods, each of which was followed by a Washout Period. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 15.6 µg QD
n=59 Participants
Participants received an inhaled dose of a dry powder formulation of umeclidinium bromide (UMEC) 15.6 micrograms (µg) once a day (QD) for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 31.25 µg QD
n=56 Participants
Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 62.5 µg QD
n=59 Participants
Participants received an inhaled dose of a dry powder formulation of UMEC 62.5 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 125 µg QD
n=60 Participants
Participants received an inhaled dose of a dry powder formulation of UMEC 125 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 15.6 µg BID
n=55 Participants
Participants received an inhaled dose of a dry powder formulation of UMEC 15.6 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 31.25 µg BID
n=57 Participants
Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
TIO 18 µg QD
n=56 Participants
Participants received tiotropium bromide (TIO) 18 µg inhalation capsules via the HandiHaler dry powder inhaler for 7 days in the morning and placebo via the DPI in the evening in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline (BL) in Serial FEV1 Over Time on Day 7 of Each Treatment Period
Pre-AMD, n=59, 58, 55, 59, 60, 54, 57, 54
|
-0.007 Liters
Standard Error 0.021
|
0.068 Liters
Standard Error 0.021
|
0.067 Liters
Standard Error 0.021
|
0.065 Liters
Standard Error 0.021
|
0.122 Liters
Standard Error 0.021
|
0.069 Liters
Standard Error 0.022
|
0.097 Liters
Standard Error 0.021
|
0.084 Liters
Standard Error 0.022
|
|
Change From Baseline (BL) in Serial FEV1 Over Time on Day 7 of Each Treatment Period
1 h AMD, n=59, 59, 56, 59, 60, 55, 57, 56
|
-0.006 Liters
Standard Error 0.023
|
0.086 Liters
Standard Error 0.023
|
0.112 Liters
Standard Error 0.023
|
0.107 Liters
Standard Error 0.023
|
0.167 Liters
Standard Error 0.023
|
0.128 Liters
Standard Error 0.024
|
0.135 Liters
Standard Error 0.023
|
0.176 Liters
Standard Error 0.023
|
|
Change From Baseline (BL) in Serial FEV1 Over Time on Day 7 of Each Treatment Period
3 h AMD, n=59, 59, 56, 59, 59, 55, 57, 56
|
-0.013 Liters
Standard Error 0.024
|
0.082 Liters
Standard Error 0.024
|
0.132 Liters
Standard Error 0.024
|
0.082 Liters
Standard Error 0.024
|
0.176 Liters
Standard Error 0.024
|
0.126 Liters
Standard Error 0.025
|
0.120 Liters
Standard Error 0.024
|
0.180 Liters
Standard Error 0.025
|
|
Change From Baseline (BL) in Serial FEV1 Over Time on Day 7 of Each Treatment Period
6 h AMD, n=59, 59, 55, 59, 59, 55, 57, 56
|
-0.054 Liters
Standard Error 0.022
|
0.056 Liters
Standard Error 0.022
|
0.067 Liters
Standard Error 0.022
|
0.056 Liters
Standard Error 0.022
|
0.088 Liters
Standard Error 0.022
|
0.045 Liters
Standard Error 0.022
|
0.081 Liters
Standard Error 0.022
|
0.128 Liters
Standard Error 0.022
|
|
Change From Baseline (BL) in Serial FEV1 Over Time on Day 7 of Each Treatment Period
9 h AMD, n=59, 59, 56, 59, 58, 55, 56, 56
|
-0.072 Liters
Standard Error 0.022
|
0.040 Liters
Standard Error 0.022
|
0.050 Liters
Standard Error 0.022
|
0.084 Liters
Standard Error 0.022
|
0.132 Liters
Standard Error 0.022
|
0.070 Liters
Standard Error 0.023
|
0.038 Liters
Standard Error 0.022
|
0.094 Liters
Standard Error 0.023
|
|
Change From Baseline (BL) in Serial FEV1 Over Time on Day 7 of Each Treatment Period
12 h AMD/Pre-PMD, n=59, 59, 56, 59, 59, 55, 57, 56
|
-0.086 Liters
Standard Error 0.023
|
0.022 Liters
Standard Error 0.023
|
0.028 Liters
Standard Error 0.023
|
0.043 Liters
Standard Error 0.023
|
0.103 Liters
Standard Error 0.023
|
0.048 Liters
Standard Error 0.023
|
0.048 Liters
Standard Error 0.023
|
0.081 Liters
Standard Error 0.023
|
|
Change From Baseline (BL) in Serial FEV1 Over Time on Day 7 of Each Treatment Period
13 h AMD/1 h PMD, n=59, 59, 56, 59, 58, 55, 57, 56
|
-0.085 Liters
Standard Error 0.024
|
-0.001 Liters
Standard Error 0.024
|
-0.003 Liters
Standard Error 0.024
|
0.026 Liters
Standard Error 0.024
|
0.103 Liters
Standard Error 0.024
|
0.063 Liters
Standard Error 0.025
|
0.041 Liters
Standard Error 0.024
|
0.061 Liters
Standard Error 0.025
|
|
Change From Baseline (BL) in Serial FEV1 Over Time on Day 7 of Each Treatment Period
15 h AMD/3 h PMD, n=59, 58, 56, 58, 59, 55, 57, 56
|
-0.112 Liters
Standard Error 0.023
|
-0.008 Liters
Standard Error 0.023
|
0.004 Liters
Standard Error 0.023
|
0.022 Liters
Standard Error 0.023
|
0.073 Liters
Standard Error 0.023
|
0.041 Liters
Standard Error 0.024
|
0.047 Liters
Standard Error 0.023
|
0.037 Liters
Standard Error 0.023
|
|
Change From Baseline (BL) in Serial FEV1 Over Time on Day 7 of Each Treatment Period
23 h AMD/11 h PMD, n=59, 57, 56, 59, 59, 55, 57,56
|
-0.101 Liters
Standard Error 0.024
|
0.006 Liters
Standard Error 0.025
|
-0.006 Liters
Standard Error 0.025
|
0.012 Liters
Standard Error 0.024
|
0.073 Liters
Standard Error 0.024
|
0.001 Liters
Standard Error 0.025
|
0.33 Liters
Standard Error 0.025
|
0.002 Liters
Standard Error 0.025
|
|
Change From Baseline (BL) in Serial FEV1 Over Time on Day 7 of Each Treatment Period
24 h AMD/12 h PMD, n=59, 58, 56, 59, 59, 55, 57,56
|
-0.065 Liters
Standard Error 0.024
|
0.070 Liters
Standard Error 0.024
|
0.065 Liters
Standard Error 0.024
|
0.067 Liters
Standard Error 0.023
|
0.146 Liters
Standard Error 0.024
|
0.083 Liters
Standard Error 0.024
|
0.084 Liters
Standard Error 0.024
|
0.049 Liters
Standard Error 0.024
|
SECONDARY outcome
Timeframe: Baseline and Day 7 of each treatment period (TP; up to Study Day 49)Population: mITT Population. All participants with \>=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 7.
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean 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 weighted mean FEV1 was calculated using 0-24 hour post-dose measurements at Day 7 of each treatment period, which included pre-dose and post-dose 1, 3, 6, 9, 12, 13, 15, 23, and 24 hours. Analysis was performed using a mixed model with covariates of mean BL, period BL, treatment, and period as fixed effects and participant as a random effect. BL is the FEV1 value recorded 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 weighted mean FEV1 at Day 7 minus the BL value for that TP.
Outcome measures
| Measure |
All Study Treatments
n=54 Participants
Participants received a sequence containing 3 of the following 8 possible treatments: placebo; UMEC 15.6 µg, 31.25 µg, 62.5 µg, and 125 µg QD; UMEC 15.6 µg and 31.25 µg BID; TIO 18 µg QD. Participants received each of the treatments in 1 of 3 7-day treatment periods, each of which was followed by a Washout Period. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 15.6 µg QD
n=56 Participants
Participants received an inhaled dose of a dry powder formulation of umeclidinium bromide (UMEC) 15.6 micrograms (µg) once a day (QD) for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 31.25 µg QD
n=51 Participants
Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 62.5 µg QD
n=54 Participants
Participants received an inhaled dose of a dry powder formulation of UMEC 62.5 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 125 µg QD
n=56 Participants
Participants received an inhaled dose of a dry powder formulation of UMEC 125 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 15.6 µg BID
n=52 Participants
Participants received an inhaled dose of a dry powder formulation of UMEC 15.6 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 31.25 µg BID
n=55 Participants
Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
TIO 18 µg QD
n=53 Participants
Participants received tiotropium bromide (TIO) 18 µg inhalation capsules via the HandiHaler dry powder inhaler for 7 days in the morning and placebo via the DPI in the evening in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline (BL) in Weighted Mean FEV1 Over 0 to 24 Hours After the Morning Dosing on Day 7 of Each Treatment Period
|
-0.074 Liters
Standard Error 0.018
|
0.043 Liters
Standard Error 0.018
|
0.045 Liters
Standard Error 0.019
|
0.059 Liters
Standard Error 0.018
|
0.100 Liters
Standard Error 0.018
|
0.062 Liters
Standard Error 0.018
|
0.068 Liters
Standard Error 0.018
|
0.084 Liters
Standard Error 0.018
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
UMEC 15.6 µg QD
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
UMEC 31.25 µg QD
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
UMEC 62.5 µg QD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
UMEC 125 µg QD
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
UMEC 15.6 µg BID
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
UMEC 31.25 µg BID
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
TIO 18 µg QD
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=60 participants at risk
Participants received matching placebo once in the morning and once in the evening for 7 days via a dry powder inhaler (DPI) in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 15.6 µg QD
n=60 participants at risk
Participants received an inhaled dose of a dry powder formulation of umeclidinium bromide (UMEC) 15.6 micrograms (µg) once a day (QD) for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 31.25 µg QD
n=57 participants at risk
Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 62.5 µg QD
n=59 participants at risk
Participants received an inhaled dose of a dry powder formulation of UMEC 62.5 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 125 µg QD
n=60 participants at risk
Participants received an inhaled dose of a dry powder formulation of UMEC 125 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 15.6 µg BID
n=56 participants at risk
Participants received an inhaled dose of a dry powder formulation of UMEC 15.6 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 31.25 µg BID
n=58 participants at risk
Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
TIO 18 µg QD
n=56 participants at risk
Participants received tiotropium bromide (TIO) 18 µg inhalation capsules via the HandiHaler dry powder inhaler for 7 days in the morning and placebo via the DPI in the evening in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/60 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
0.00%
0/60 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
1.8%
1/57 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
0.00%
0/59 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
0.00%
0/60 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
0.00%
0/56 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
0.00%
0/58 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
0.00%
0/56 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/60 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
1.7%
1/60 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
0.00%
0/57 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
0.00%
0/59 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
0.00%
0/60 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
0.00%
0/56 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
0.00%
0/58 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
0.00%
0/56 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
Other adverse events
| Measure |
Placebo
n=60 participants at risk
Participants received matching placebo once in the morning and once in the evening for 7 days via a dry powder inhaler (DPI) in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 15.6 µg QD
n=60 participants at risk
Participants received an inhaled dose of a dry powder formulation of umeclidinium bromide (UMEC) 15.6 micrograms (µg) once a day (QD) for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 31.25 µg QD
n=57 participants at risk
Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 62.5 µg QD
n=59 participants at risk
Participants received an inhaled dose of a dry powder formulation of UMEC 62.5 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 125 µg QD
n=60 participants at risk
Participants received an inhaled dose of a dry powder formulation of UMEC 125 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 15.6 µg BID
n=56 participants at risk
Participants received an inhaled dose of a dry powder formulation of UMEC 15.6 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
UMEC 31.25 µg BID
n=58 participants at risk
Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
TIO 18 µg QD
n=56 participants at risk
Participants received tiotropium bromide (TIO) 18 µg inhalation capsules via the HandiHaler dry powder inhaler for 7 days in the morning and placebo via the DPI in the evening in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
|
|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
3.3%
2/60 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
1.7%
1/60 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
0.00%
0/57 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
0.00%
0/59 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
5.0%
3/60 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
7.1%
4/56 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
1.7%
1/58 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
0.00%
0/56 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/60 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
1.7%
1/60 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
0.00%
0/57 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
0.00%
0/59 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
1.7%
1/60 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
0.00%
0/56 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
0.00%
0/58 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
3.6%
2/56 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/60 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
1.7%
1/60 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
0.00%
0/57 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
0.00%
0/59 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
3.3%
2/60 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
0.00%
0/56 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
0.00%
0/58 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
0.00%
0/56 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/60 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
0.00%
0/60 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
0.00%
0/57 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
0.00%
0/59 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
3.3%
2/60 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
0.00%
0/56 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
0.00%
0/58 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
0.00%
0/56 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occuring while participants were on treatment up until one day after the last dose (up to 7 weeks), are reported.
On-treatment SAEs and non-serious AEs were reported for members of the mITT Population, comprised of all participants who were randomized to treatment who had received at least one dose of study medication.
|
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