Efficacy and Safety of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-06)
The aim of the study is to investigate the effect of roflumilast (APTA-2217) on lung function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally once daily. The study duration consists of a baseline period (4 weeks) and a treatment period (24 weeks). The study will provide further data on safety, tolerability, and effectiveness of roflumilast.
Chronic Obstructive Pulmonary Disease (COPD)
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Confirmatory Study of APTA-2217 in Patients With Chronic Obstructive Pulmonary Disease (A Placebo-controlled Double-blind Comparative Study)|
- change in lung function parameters (post-bronchodilator).
- pulmonary function test, COPD symptoms, rescue medication, evaluation of QOL, COPD exacerbation, adverse events, pharmacokinetics.
|Study Start Date:||November 2004|
|Study Completion Date:||March 2007|
|Primary Completion Date:||September 2006 (Final data collection date for primary outcome measure)|
|Nycomed Japan and Mitsubishi Tanabe Oharma Corporation|
|Study Chair:||Gerhard Cullmann||Nycomed GmbH, 78467 Konstanz|