Conditions: COPD
Keywords: COPD Roflumilast FEV1 China
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 626
Healthy volunteers: no

Brief summary:
The aim of this trial is to determine the efficacy, safety and tolerability of 500 µg Roflumilast tablets once daily in patients with COPD in China, Hong Kong, and Singapore.

Detailed description:

Arms:
arm 1: Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks. arm 2: Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.

Interventions: intervention 1: Roflumilast intervention 2: Placebo intervention 3: Salbutamol
Intervention descriptions: intervention 1: Roflumilast tablets intervention 2: Placebo tablets intervention 3: Salbutamol (given by MDI and spacer) used as rescue medication on an ass needed basis throughout the trial, and was used for post-bronchodilator spirometry tests at all study visits.

Protocol document: