Status:
COMPLETED
Efficacy and Safety of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-06)
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Tanabe Pharma Corporation
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
40+ years
Phase:
PHASE2
PHASE3
Brief Summary
The aim of the study is to investigate the effect of roflumilast (APTA-2217) on lung function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally onc...
Eligibility Criteria
Inclusion
- Main inclusion criteria:
- Patients with chronic obstructive pulmonary disease
- Current smoker or ex-smoker
- 30 to 80% of predicted FEV1 after inhalation of short acting beta stimulant
- Main exclusion criteria:
- Patients with poorly controlled COPD
- Patients who need for long-term oxygen therapy
- Patients who have concurrent respiratory diseases such as asthma, diffuse panbronchiolitis, congenital sinobronchial syndrome, bronchiolitis obliterans, bronchiectasis, active tuberculosis, pneumoconiosis, pulmonary lymph vascular myoma, which are considered to affect the evaluation
Exclusion
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
570 Patients enrolled
Trial Details
Trial ID
NCT00242294
Start Date
November 1 2004
End Date
March 1 2007
Last Update
October 26 2016
Active Locations (1)
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1
Nycomed Japan and Mitsubishi Tanabe Oharma Corporation
Osaka, Japan