Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Roflumilast COPD Chronic obstructive pulmonary disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1568
Healthy volunteers: no

Brief summary:
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.

For additional information (for US patients only) see www.COPDSTUDY.net or dial 866-788-2673 (toll free).

Detailed description:

Arms:
arm 1: 500 mcg, once daily, oral administration in the morning arm 2: once daily

Interventions: intervention 1: Roflumilast intervention 2: Placebo
Intervention descriptions: intervention 1: 500 mcg, once daily, oral administration in the morning intervention 2: once daily

Protocol document: