Efficacy and Safety of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 70 y) (APTA-2217-05)
The aim of the study is to investigate the effect of roflumilast (APTA-2217) on lung function in patients with asthma. Roflumilast will be administered orally once daily. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (24 weeks). The study will provide further data on safety, tolerability, and effectiveness of roflumilast.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Confirmatory Study of APTA-2217 in Adult Patients With Bronchial Asthma (A Placebo-controlled Double-blind Comparative Study)|
- change in lung function parameters.
- pulmonary function test (spirometry), asthma symptoms, rescue medication, evaluation of QOL, asthma exacerbation, adverse events, pharmacokinetics.
|Study Start Date:||May 2004|
|Study Completion Date:||June 2007|
|Primary Completion Date:||September 2006 (Final data collection date for primary outcome measure)|
|Nycomed Japan and Mitsubishi Tanabe Pharma Corporation|
|Study Chair:||Gerhard Cullmann||Nycomed GmbH, 78467 Konstanz, Germany|