Efficacy and safety of roflumilast in Japanese patients with bronchial asthma (20 to 70 y) (APTA-2217-05)

Inclusion Criteria

• 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