Efficacy and Safety of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 70 y) (APTA-2217-05).

A Confirmatory Study of APTA-2217 in Adult Patients With Bronchial Asthma (A Placebo-controlled Double-blind Comparative Study)

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.

Main inclusion criteria:

• Adult patients with bronchial asthma meeting the Guideline for Prevention and Control of Asthma 2003 (JGL 1998, revised 2nd edition)
• No change in asthma treatment during the last 4 weeks prior to the registration
• Non-smokers or ex-smokers for 12 months or more
• %FEV1 ranging between 60 and 80%

Main exclusion criteria:

• Patients with poorly controlled asthma
• Inhalation therapy exceeding low dose during 4 weeks prior to the registration
• Concurrent respiratory diseases such as COPD considered to affect the efficacy evaluation