At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, 3-Way, Cross-Over Study to Evaluate Lung Function Response After Treatment With Umeclidinium 62.5mcg, Vilanterol 25mcg, and Umeclidinium/Vilanterol 62.5/25mcg Once-Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
In Brief
A Phase 3 clinical trial evaluating Umeclidinium/Vilanterol 62.5/25 mcg, Umeclidinium 62.5 mcg, and 1 other intervention for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 182 participants across 21 sites in 2 countries.
Detailed Summary
The purpose of this study is to evaluate the lung function response to UMEC/VI, UMEC, and VI in individual patients using a cross-over design. This is a multicenter, randomized, double-blind, 3-way crossover study. Eligible subjects will be randomized to a sequence of UMEC 62.5mcg, VI 25mcg, and UMEC/VI 62.5/25mcg. All subjects will receive each treatment once-daily for 14 days, and each treatment will be separated by a 10-14 day washout period. There will be a 5-7 day run-in period prior to randomization.
Study Details
Timeline
Interventions
Umeclidinium/Vilanterol 62.5/25 mcg once daily in the morning via novel dry powder inhaler (NDPI)
Umeclidinium 62.5 mcg once daily in the morning via novel dry powder inhaler (NDPI)
Vilanterol 25 mcg once daily in the morning via novel dry powder inhaler (NDPI)