CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 905 enrolled
Drug / intervention
Umeclidinium/Vilanterol 62.5/25 mcg +1 moredrug
Likely dose
Umeclidinium/Vilanterol 62.5/25 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/NCT01777334
NCT01777334Phase 3Completed
CompareCT.gov

A Multicenter, Trial Comparing the Efficacy and Safety of Umeclidinium/Vilanterol 62.5/25 mcg Once Daily With Tiotropium 18 mcg Once Daily Over 24 Weeks in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

GlaxoSmithKline·interventional·Posted Jan 28, 2013·Updated Jan 24, 2018

In Brief

A Phase 3 clinical trial evaluating Umeclidinium/Vilanterol 62.5/25 mcg and Tiotropium 18 mcg for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 905 participants across 70 sites in 9 countries.

Detailed Summary

The purpose of this 24 week study is to evaluate the spirometric lung function effect (trough FEV1) of Umeclidinium/Vilanterol 62.5/25 once daily compared to Tiotropium 18 mcg once daily along with safety assessments in subjects with COPD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive
CountriesArgentina, Bulgaria, Canada, Germany, Hungary, Romania, Russia, Spain, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 28, 2013
Enrollment StartJan 23, 2013
Primary CompletionSep 24, 2013
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 13.4 years ago

Interventions

Umeclidinium/Vilanterol 62.5/25 mcgdrug

Inhalation Powder

Tiotropium 18 mcgdrug

Inhalation Powder