Status:
COMPLETED
Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 71 y) (APTA-2217-07)
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Tanabe Pharma Corporation
Conditions:
Bronchial Asthma
Eligibility:
All Genders
20-71 years
Phase:
PHASE3
Brief 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. Rof...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
End Date :
October 1 2007
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00246922
Start Date
December 1 2004
End Date
October 1 2007
Last Update
December 2 2016
Active Locations (1)
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1
Nycomed Japan and Mitsubishi Tanabe Pharma Corporation
Osaka, Japan