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

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Mitsubishi Tanabe Pharma Corporation

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