At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 497 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.
DB2116960: A Randomized, Double-Dummy, Parallel Group, Multicenter Trial Comparing the Efficacy and Safety of UMEC/VI (a Fixed Combination of Umeclidinium and Vilanterol) With Tiotropium In Subjects With COPD Who Continue To Have Symptoms on Tiotropium
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 497 participants across 64 sites in 10 countries.
Detailed Summary
The primary objective is to compare the efficacy of UMEC/VI Inhalation Powder (62.5/25 mcg) once-daily with tiotropium (18 mcg) once-daily over 12 weeks for the treatment of subjects with COPD who have received tiotropium and continue to have symptoms while on tiotropium.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive
CountriesArgentina, Estonia, Germany, Norway, Russia, South Africa, South Korea, Sweden, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 2013
Enrollment StartSep 2014
Primary CompletionJul 2015
TodayJul 2026
First PostedJul 15, 2013
Enrollment StartSep 15, 2014
Primary CompletionJul 22, 2015
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 13.0 years ago
Interventions
Umeclidinium/Vilanterol 62.5/25 mcgdrug
Inhalation Powder
Tiotropium 18 mcgdrug
Inhalation Powder