Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 71 y) (APTA-2217-07)

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this long-term study is to investigate the effect of roflumilast (APTA-2217) on the long-term safety in patients with asthma, who completed the 24-week evaluation of study APTA-2217-05. Roflumilast will be administered orally once daily. The present study consists of a 28 weeks treatment period, and is the extension of the 24-week study APTA-2217-05 (registered study). The study will provide further long-term safety and efficacy data of roflumilast.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Main inclusion criteria:

• Patients with asthma disease

• Written informed consent

• Patients who completed the 24-week evaluation of study APTA-2217-05

Main exclusion criteria:

• % FEV1.0 < 60% at both 18 weeks and 24 weeks measurements during APTA-2217-05

• Patients with poorly controlled asthma between informed consent day and study starting day: need for oral or intravenous steroid therapy, hospitalization or any emergency visit, PEF value worsened for 2 or more consecutive days

• Serious diseases