drugset / Trial / NCT01899742

The Purpose of the This Study is to Evaluate the Spirometric Effect (Trough FEV1) of Umeclidinium/Vilanterol 62.5/25 mcg Once Daily Compared With Tiotropium 18mcg Once Daily Over a a 12-week Treatment Period in Subjects With COPD Who Continue to Have Symptoms on Tiotropium

NCT01899742

Phase 3 Completed 497 enrolled GlaxoSmithKline
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2014-09-15
Primary completion
2015-07-22
Completion
2015-07-22

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tiotropium Other / unclassified 18 ug Inhaled
Subject Umeclidinium Other / unclassified 62.5 ug Inhaled
Subject Vilanterol Other / unclassified 25 ug Inhaled