A Study to Evaluate the 24 Hour Spirometric Effect (FEV1) of Fluticasone Furoate/Vilanterol Inhalation Powder (100mcg Fluticasone Furoate (FF)/25mcg Vilanterol (VI)) Compared With Salmeterol/Fluticasone Propionate Inhalation Powder (50mcg Salmeterol/500mcg Fluticasone Propionate (FP))
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|ClinicalTrials.gov Identifier: NCT01342913|
Recruitment Status : Completed
First Posted : April 27, 2011
Results First Posted : July 30, 2013
Last Update Posted : August 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Disease, Chronic Obstructive||Drug: Fluticasone Furoate 100mcg/Vilanterol 25mcg Drug: Fluticaosne Propionate 500mcg/Salmeterol 50mcg||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||528 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A 12-week Study to Evaluate the 24 Hour Pulmonary Function of Fluticasone Furoate (FF)/Vilanterol Inhalation Powder (FF/VI Inhalation Powder) Once Daily Compared With Salmeterol/Fluticasone Propionate (FP) Inhalation Powder Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)|
|Study Start Date :||February 1, 2011|
|Actual Primary Completion Date :||October 1, 2011|
|Actual Study Completion Date :||October 19, 2011|
Experimental: Fluticasone Furoate/Vilanterol
Inhaled Corticosteroid (ICS)/Long Acting Beta Agonist (LABA)
Drug: Fluticasone Furoate 100mcg/Vilanterol 25mcg
Active Comparator: Fluticasone Propionate/Salmeterol
Inhaled Corticosteroid (ICS)/Long Acting Beta Agonist (LABA
Drug: Fluticaosne Propionate 500mcg/Salmeterol 50mcg
- 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). The weighted mean was calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, 30, and 60 minutes (min) and 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 was calculated as the average of the Day 84 values minus the Baseline value.
- Time to Onset on Treatment Day 1 [ Time Frame: 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 min, 15 min, 30 min, 60 min, 120 min, and 240 min) post-dose.
- Change From Baseline in Trough FEV1 on Treatment Day 85 [ Time Frame: Baseline and Day 85 ]Pulmonary function was measured by forced expiratory volume in one second (FEV1). Trough FEV1 was defined as the 24-hour FEV1 assessment, which was obtained on Day 85. 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 85 values minus the Baseline value.
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): NCT01342913
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|Study Director:||GSK Clinical Trials||GlaxoSmithKline|