drugset / Trial / NCT01627327

Study to Evaluate the 24-Hour Pulmonary Function Profile of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25mcg Once Daily Compared With Tiotropium Bromide Inhalation Powder 18mcg Once Daily in Subjects With COPD Who Have or Are At Risk for Co-morbid Cardiovascular Disease

NCT01627327

Phase 3 Completed 623 enrolled GlaxoSmithKline
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of Fluticasone Furoate/Vilanterol Inhalation Powder 100/25mcg once daily compared with tiotropium bromide inhalation powder 18mcg once daily over a 12-week treatment period in subjects with COPD who have or are at risk for co-morbid cardiovascular disease

Timeline

Start
2012-04-01
Primary completion
2012-12-01
Completion
2012-12-21

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tiotropium Other / unclassified 18 ug Inhaled
Subject fluticasone furoate/vilanterol Unknown 25 ug Inhaled
Subject fluticasone furoate/vilanterol Unknown 100 ug Inhaled