drugset / Trial / NCT00242320

Efficacy and Safety of Oral Roflumilast Taken Once Daily in Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (BY217/M2-119)

NCT00242320

Phase 3 Completed 551 enrolled AstraZeneca
RandomizedParallel-groupDouble-blindTreatment

Summary

The aim of the study is to compare the effect of roflumilast on lung function in patients with COPD. Roflumilast will be administered orally once daily in the morning at one dose level. The study duration consists of a baseline period (4 weeks) and a treatment period (12 weeks). The study will provide further data on safety and tolerability of roflumilast.

Timeline

Start
2005-08
Primary completion
2007-05
Completion
2007-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Roflumilast Small molecule 500 ug Oral