CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 338 enrolled
Drug / intervention
FF +2 moredrug
Likely dose
FF 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/NCT02164539
NCT02164539Phase 2Completed
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200699: A Clinical Study to Evaluate Four Doses of Umeclidinium Bromide in Combination With Fluticasone Furoate in COPD Subjects With an Asthmatic Component

GlaxoSmithKline·interventional·Posted Jun 16, 2014·Updated Oct 11, 2017

In Brief

A Phase 2 clinical trial evaluating FF, UMEC, and 1 other intervention for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 338 participants across 67 sites in 7 countries.

Detailed Summary

The purpose of this study is to evaluate the dose-response of 4 doses of umeclidinium bromide in combination with fluticasone furoate compared with fluticasone furoate monotherapy in chronic obstructive pulmonary disease participants with an asthmatic component. The fluticasone furoate/umeclidinium bromide treatments will also be compared to the once-daily inhaled corticosteroid/long-acting beta agonist combination fluticasone furoate/vilanterol.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive
CountriesArgentina, Germany, Poland, Romania, Russia, Ukraine, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 16, 2014
Enrollment StartJul 1, 2014
Primary CompletionJul 1, 2015
Study CompletionJul 18, 2015
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 12.0 years ago

Interventions

FFdrug

Fluticasone furoate is available as fluticasone furoate inhalation powder (100 mcg per blister), combination of fluticasone furoate/umeclidinium bromide inhalation powder (fluticasone furoate: 100 mcg per blister, umeclidinium bromide: 15.6, 62.5, 125, or 250 mcg per blister) and combination of fluticasone furoate/vilanterol inhalation powder (fluticasone furoate: 100 mcg per blister, vilanterol: 25 mcg per blister)

UMECdrug

Umeclidinium bromide is available as combination of fluticasone furoate/umeclidinium bromide inhalation powder (fluticasone furoate: 100 mcg per blister, umeclidinium bromide: 15.6, 62.5, 125, or 250 mcg per blister)

VIdrug

Vilanterol is available as vilanterol inhalation powder (25 mcg per blister) and combination of fluticasone furoate/vilanterol inhalation powder (fluticasone furoate: 100 mcg per blister, vilanterol: 25 mcg per blister)