Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD Roflumilast
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 743
Healthy volunteers: no

Brief summary:
The aim of the study is to compare the efficacy of roflumilast to placebo on pulmonary function and symptomatic parameters in patients with chronic obstructive pulmonary disease (COPD) during concomitant administration of tiotropium. The study duration will last up to 28 weeks. The study will provide further data on safety and tolerability of roflumilast.

Detailed description:

Arms:
arm 1: Roflumilast 500 µg

underlying medication: tiotropium 18 µg, once daily, inhaled arm 2: Placebo

underlying medication: tiotropium 18 µg, once daily, inhaled

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

Protocol document: