Status:
COMPLETED
A Study to Assess the Safety and Efficacy of Different AD 237 Doses in Adults With COPD
Lead Sponsor:
Sosei
Collaborating Sponsors:
Novartis
Conditions:
COPD
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to investigate the efficacy, safety and tolerability of AD 237 in patients with chronic obstructive pulmonary disease (COPD).
Eligibility Criteria
Inclusion
- Diagnosed with COPD, with symptoms of cough and chronic sputum production and/or dyspnea.
- Post-bronchodilator FEV1 at no more than 65% and at least 30% of the predicted normal value.
- Pre-bronchodilator FEV1/FVC ratio of less than 70%.
- Current or ex-smokers with a smoking history of at least 10 pack years.
Exclusion
- History of asthma, atopy or allergic rhinitis.
- Other serious respiratory or other medical conditions which may interfere with the outcome of the study.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00242333
Start Date
October 1 2005
Last Update
May 16 2006
Active Locations (33)
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1
Specialized Hospital for Active Treatment Pneumophthysiatric Disease "Kudoglu"
Plovdiv, Bulgaria, 4000
2
Regional Dispensary for Pulmonary Diseases Rousse
Rousse, Bulgaria, 7002
3
5-th Multiprofile Hospital for Active Treatment
Sofia, Bulgaria, 1233
4
MHAT "Alexandrovska"
Sofia, Bulgaria, 1431