CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 617 enrolled
Drug / intervention
Umeclidinium bromide 62.5mcg +3 moredrug
Likely dose
Umeclidinium bromide 62.5mcgfrom 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/NCT01772134
NCT01772134Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of the Addition of Umeclidinium Bromide (62.5mcg) Once-daily to Fluticasone Propionate/Salmeterol (250/50mcg) Twice-daily, Umeclidinium Bromide (125mcg) Once-daily to Fluticasone Propionate/Salmeterol (250/50mcg) Twice-daily Versus Placebo to Fluticasone Propionate/Salmeterol (250/50mcg) Twice-daily Over 12 Weeks With COPD

GlaxoSmithKline·interventional·Posted Jan 21, 2013·Updated Jan 29, 2018

In Brief

A Phase 3 clinical trial evaluating Umeclidinium bromide 62.5mcg, Umeclidinium bromide 125mcg, and 2 other interventions for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 617 participants across 73 sites in 4 countries.

Detailed Summary

The purpose of this 12 week study is to evaluate the effects of the addition of umeclidinium bromide (62.5mcg) once-daily to fluticanse propionate/salmeterol (250/50mcg) twice-daily, umeclidinium bromide (125mcg) once-daily to fluticanse propionate/salmeterol (250/50mcg) twice-daily versus placebo to fluticanse propionate/salmeterol (250/50mcg) twice-daily on lung function, COPD-related health status assessments and safety in COPD subjects.

Study Details

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

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 21, 2013
Enrollment StartJan 1, 2013
Primary CompletionJul 1, 2013
Study CompletionJul 22, 2013
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 13.4 years ago

Interventions

Umeclidinium bromide 62.5mcgdrug

Inhalation Powder, LAMA 62.5mcg

Umeclidinium bromide 125mcgdrug

Inhalation Powder, LAMA 125mcg

Fluticasone propionate 250mcg/Salmeterol 50mcgdrug

Inhalation Powder, ICS/LABA

Placebodrug

Inhalation Powder, Placebo