CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 283 enrolled
Drug / intervention
Fluticasone Furoate/Vilanterol +1 moredrug
Likely dose
Fluticasone Furoate/Vilanterol 100 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01957150
NCT01957150Phase 4Completed
CompareCT.gov

Multi-centre, Randomized, Double-blind, Parallel-group Study Evaluating the Effect of Fluticasone Furoate/ Vilanterol (FF/VI) Inhalation Powder Once Daily Compared With Vilanterol (VI) Inhalation Powder Once Daily on Bone Mineral Density (BMD) in Subjects With Chronic Obstructive Pulmonary Disease (COPD).

GlaxoSmithKline·interventional·Posted Oct 8, 2013·Updated Apr 10, 2019

In Brief

A Phase 4 clinical trial evaluating Fluticasone Furoate/Vilanterol and Vilanterol for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 283 participants across 45 sites in 5 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive
CountriesCanada, Germany, Netherlands, Spain, United States
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 8, 2013
Enrollment StartJan 28, 2014
Primary CompletionMar 26, 2018
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 12.7 years ago

Interventions

Fluticasone Furoate/Vilanteroldrug

Dry white powder containing 100 mcg of Fluticasone Furoate blended with lactose per blister was administered by NDPI. Dry white powder containing 25 mcg of Vilanterol micronised drug (as the 'M' salt triphenylacetate) blended with lactose and magnesium stearate per blister was administered by NDPI.

Vilanteroldrug

Dry white powder containing 25 mcg of Vilanterol micronised drug (as the 'M' salt triphenylacetate) blended with lactose and magnesium stearate per blister was administered by NDPI.