Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The HERMES Study (BY217/M2-125)

The aim of the study is to compare the effect of roflumilast on exacerbation rate and pulmonary function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally once daily in the morning at one dose level. The study duration will be up to 56 weeks. The study will provide further data on safety and tolerability of roflumilast.


Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Roflumilast on Exacerbation Rate in Patients With COPD. The HERMES Study
Enrollment: 1568
Study Start Date: March 2006
Study Completion Date: August 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)

Arms:
- Active Comparator: Roflumilast
- Placebo Comparator: Placebo