drugset / Trial / NCT01957150

Study Evaluating the Effect of Fluticasone Furoate/ Vilanterol (FF/VI) Inhalation Powder Compared With Vilanterol (VI) Inhalation Powder on Bone Mineral Density (BMD) in Subjects With Chronic Obstructive Pulmonary Disease (COPD).

NCT01957150

Phase 4 Completed 283 enrolled GlaxoSmithKline
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a multi-center, randomized, double-blind, parallel-group study. The FF/VI inhalation powder once daily and VI inhalation powder once daily will be evaluated in subjects with COPD over 156 weeks. The primary objective of this study is to evaluate the effect of the inhaled corticosteroid FF on bone mineral density assessed at the total hip by comparing FF/VI treatment with VI treatment in subjects with moderate COPD.

Timeline

Start
2014-01-28
Primary completion
2018-03-26
Completion
2018-03-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluticasone Furoate Other / unclassified 100 ug Inhaled
Subject Vilanterol Other / unclassified 25 ug Inhaled