Study to Evaluate the 24-Hour Pulmonary Function Profile of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25mcg Once Daily Compared With Tiotropium Bromide Inhalation Powder 18mcg Once Daily in Subjects With COPD Who Have or Are At Risk for Co-morbid Cardiovascular Disease
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|ClinicalTrials.gov Identifier: NCT01627327|
Recruitment Status : Completed
First Posted : June 25, 2012
Results First Posted : November 1, 2013
Last Update Posted : November 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Disease, Chronic Obstructive||Drug: fluticasone furoate/vilanterol 100/25mcg Drug: tiotropium bromide 18mcg||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||623 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A 12-Week Study to Evaluate the 24-Hour Pulmonary Function Profile of Fluticasone Furoate /Vilanterol (FF/VI) Inhalation Powder 100/25mcg Once-Daily Via a Novel Dry Powder Inhaler Compared With Tiotropium Bromide Inhalation Powder 18mcg Delivered Once-Daily Via the HandiHaler in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Who Have or Are at Risk for Co-morbid Cardiovascular Disease|
|Study Start Date :||April 1, 2012|
|Actual Primary Completion Date :||December 1, 2012|
|Actual Study Completion Date :||December 21, 2012|
Experimental: fluticasone furoate/vilanterol
inhaled corticosteroid (ICS)/long-acting beta2-agonist (LABA)
Drug: fluticasone furoate/vilanterol 100/25mcg
Active Comparator: tiotropium bromide
Drug: tiotropium bromide 18mcg
Other Name: Spiriva
- Change From Baseline Trough in 24-hour Weighted Mean FEV1 on Treatment Day 84 [ Time Frame: Baseline and Day 84 ]Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. The weighted mean was calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, 30 minutes and 1, 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours on Treatment Day 84. Baseline trough FEV1 was the mean of the two assessments made 30 and 5 minutes pre-dose on Treatment Day 1. Change from Baseline (BL) was calculated as the average of the Day 84 values minus the Baseline value. Analysis was performed using an analysis of covariance (ANCOVA) model with covariates of BL FEV1, exacerbation history and reversibility stratum, smoking status at screening, country, and treatment group.
- Time to Onset on Treatment Day 1 [ Time Frame: Baseline and Day 1 ]Time to onset on Treatment Day 1 is defined as the time to an increase of 100 milliliters (mL) from Baseline in FEV1. Time of onset was calculated over 0 to 4 hours (5 minutes (min), 15 min, 30 min, 60 min, 120 min, and 240 min) post-dose. Time to onset was analyzed using a log-rank test, stratified by exacerbation history and reversibility stratum.
- Change From Baseline in Trough FEV1 at Treatment Day 84 [ Time Frame: Baseline and Day 84 ]Pulmonary function was measured by FEV1. Trough FEV1 was defined as the 24-hour FEV1 assessment, which was obtained on Day 84. Baseline is defined as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Change from Baseline was calculated as the average of the Day 84 values minus the Baseline value. Analysis was performed using an ANCOVA model with covariates of BL FEV1, exacerbation history and reversibility stratum, smoking status at screening, country, and treatment group.
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): NCT01627327
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|Study Director:||GSK Clinical Trials||GlaxoSmithKline|