drugset / Trial / NCT01607398

ADOAIR250 Anti-inflammatory Effects in Japanese Subjects With Chronic Obstructive Pulmonary Disease

NCT01607398

Phase 4 Completed 56 enrolled GlaxoSmithKline
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The study will be conducted in a respiratory specialist institute in Japan, with standardized techniques and data assurance checks to optimize data quality. The licensed dosage and administration of Adoair in Japan will be applied in this study. Each subject will receive treatment options in a randomized blinded fashion. Subjects will be randomized following a 4-week wash-out phase to take either Adoair 50/250mcg twice daily or placebo twice daily for 12 weeks.

Timeline

Start
2012-05
Primary completion
2013-07
Completion
2013-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluticasone propionate Other / unclassified 250 ug Inhaled
Subject Salmeterol Other / unclassified 50 ug Inhaled