Efficacy and safety of fluticasone furoate/vilanterol (50/25 mcg; 100/25 mcg; 200/25 mcg) in Asian patients with chronic obstructive pulmonary disease: a randomized placebo-controlled trial

Abstract Background and objective: Three strengths of fluticasone furoate/vilanterol (FF/VI) were previously evaluated for the treatment of chronic obstructive pulmonary disease (COPD) in a program of global Phase 3 studies that included only a small subgroup of Asian patients. This study further ev...

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Bibliographic Details
Published in:Current medical research and opinion 2015-06, Vol.31 (6), p.1191-1200
Main Authors: Zheng, Jinping, de Guia, Teresita, Wang-Jairaj, Jie, Newlands, Amy H., Wang, Changzheng, Crim, Courtney, Zhong, Nanshan
Format: Article
Language:English
Subjects:
Administration, Inhalation
Aged
Albuterol - therapeutic use
Androstadienes - administration & dosage
Androstadienes - adverse effects
Asian Continental Ancestry Group
Benzyl Alcohols - administration & dosage
Benzyl Alcohols - adverse effects
Bronchodilator agents
Chlorobenzenes - administration & dosage
Chlorobenzenes - adverse effects
Clinical respiratory medicine
Clinical trials
COPD
Dose-Response Relationship, Drug
Double-Blind Method
Drug Combinations
Dry Powder Inhalers
Female
Glucocorticoids - adverse effects
Humans
Hydrocortisone - metabolism
Male
Middle Aged
Pulmonary Disease, Chronic Obstructive - drug therapy
Respiratory function test
Treatment Outcome
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Summary:Abstract Background and objective: Three strengths of fluticasone furoate/vilanterol (FF/VI) were previously evaluated for the treatment of chronic obstructive pulmonary disease (COPD) in a program of global Phase 3 studies that included only a small subgroup of Asian patients. This study further evaluated the efficacy and safety of the same three strengths of FF/VI exclusively in Asian patients. Methods: A randomized, double-blind, placebo-controlled, parallel-group, multicenter study. Patients with post-bronchodilator FEV1/FVC 0.70, FEV1 70% predicted and modified Medical Research Council score 2 were randomized (1:1:1:1) to placebo, FF/VI 50/25 mcg, 100/25 mcg or 200/25 mcg once daily via the ELLIPTA dry powder inhaler. The primary efficacy endpoint was change from baseline in trough FEV1 at Week 24. Results: The intent-to-treat population comprised 643 patients. Statistically significant (p 
ISSN:0300-7995
1473-4877
DOI:10.1185/03007995.2015.1036016