A Study to Evaluate the Efficacy and Safety of Umeclidinium Bromide/Vilanterol Compared With Fluticasone Propionate/Salmeterol Over 12 Weeks in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
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|ClinicalTrials.gov Identifier: NCT01822899|
Recruitment Status : Completed
First Posted : April 2, 2013
Results First Posted : May 29, 2014
Last Update Posted : September 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Disease, Chronic Obstructive||Drug: Umeclidinium bromide/Vilanterol Drug: Placebo ACCUHALER/DISKUS Drug: Fluticasone propionate/Salmeterol Drug: Placebo NDPI||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||717 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||DB2116134: A Randomized, Multi-center, Double-blind, Double-dummy, Parallel Group Study to Evaluate the Efficacy and Safety of Umeclidinium Bromide/Vilanterol Compared With Fluticasone Propionate/Salmeterol Over 12 Weeks in Subjects With COPD|
|Study Start Date :||April 4, 2013|
|Actual Primary Completion Date :||October 1, 2013|
|Actual Study Completion Date :||October 7, 2013|
Experimental: Umeclidinium bromide/Vilanterol + placebo ACCUHALER/DISKUS
Subjects will receive UMEC/ VI 62.5/25 mcg, one inhalation administered once-daily in the morning via the NDPI and one placebo ACCUHALER/DISKUS administered as one inhalation each morning and evening.
Drug: Umeclidinium bromide/Vilanterol
Dry white powder of UMEC 62.5 mcg per blister and VI 25 mcg per blister as NDPI with 30 doses (2 strips with 30 blisters per strip).
Drug: Placebo ACCUHALER/DISKUS
Dry white powder of matching placebo as multidose dry powder inhaler containing a foil strip with 60 blisters (1 strip with 60 blisters per strip).
Active Comparator: Fluticasone propionate/Salmeterol + placebo NDPI
Subjects will receive FSC 500/50 mcg, administered as one inhalation each morning and evening via ACCUHALER/DISKUS + placebo administered once daily in the morning via NDPI.
Drug: Fluticasone propionate/Salmeterol
Dry white powder of fluticasone propionate 500 mcg per blister 50 mcg salmeterol per blister as multidose dry powder inhaler containing a foil strip with 60 blisters (1 strip with 60 blisters per strip).
Drug: Placebo NDPI
Dry white powder of matching placebo as NDPI with 30 doses (2 strips with 30 blisters per strip).
- Change From Baseline (BL) in 0 to 24 Hour Weighted Mean Serial Forced Expiratory Volume in One Second (FEV1) at Day 84 [ Time Frame: Baseline and Day 84 ]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 was calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5 and 15 minutes and 1, 3, 6, 9, 12 (pre-evening dose), 13, 15, 18, 23, and 24 hours after the morning dose. Analysis was performed using an analysis of covariance (ANCOVA) model with covariates of treatment, Baseline FEV1 (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), and smoking status.
- Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) at Day 85 [ Time Frame: Baseline and Day 85 ]FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. BL is defined as the mean of the assessments made 30 and 5 minutes (min) pre-dose on Treatment Day 1. Trough FEV1 on Day 85 is defined as the mean of the FEV1values obtained 23 and 24 hours after the previous morning's dosing (i.e., trough FEV1 on Day 85 is the mean of the FEV1 values obtained 23 and 24 hours after morning dosing on Day 84). Analysis was performed using a repeated measures model with covariates of treatment, BL (mean of the two assessments made 30 min and 5 min pre-dose on Day 1), smoking status, day, and day by BL and day by treatment interactions. The model used all available trough FEV1 values recorded on Days 28, 56, 84, and 85. Missing data were not directly imputed in this analysis; however, all non-missing data for a participant were used within the analysis to estimate the treatment effect for trough FEV1 at Day 85.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01822899
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|Study Director:||GSK Clinical Trials||GlaxoSmithKline|