A Study to Assess the Safety and Efficacy of Different AD 237 Doses in Adults With COPD

Phase 2

Completed

• Conditions: COPD

• Registration Number: NCT00242333
• Lead Sponsor: Sosei

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2005-10-19
• Study First Submitted QC: 2005-10-19
• Study First Posted: 2005-10-20
• Status Verified: 2006-05
• Last Update Submitted: 2006-05-15
• Last Update Posted: 2006-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• 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 Criteria

• History of asthma, atopy or allergic rhinitis.
• Other serious respiratory or other medical conditions which may interfere with the outcome of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pulmonary function

Secondary Outcome Measures

Name	Time	Method
Pulmonary function

Trial Locations

Locations (33)

Specialized Hospital for Active Treatment Pneumophthysiatric Disease "Kudoglu"; 🇧🇬 Plovdiv, Bulgaria

Regional Dispensary for Pulmonary Diseases Rousse; 🇧🇬 Rousse, Bulgaria

5-th Multiprofile Hospital for Active Treatment; 🇧🇬 Sofia, Bulgaria

MHAT "Alexandrovska"; 🇧🇬 Sofia, Bulgaria

Specialized Hospital for Active Treatment of Pulmonary Diseases "Sveta Sofia"; 🇧🇬 Sofia, Bulgaria

Central Clinical Base - Medical Institute - Ministry of the Interior; 🇧🇬 Sofia, Bulgaria

Military Medical Academy; 🇧🇬 Sofia, Bulgaria

UMHAT "Stara Zagora" EAD; 🇧🇬 Stara Zagora, Bulgaria

University Hospital; 🇧🇬 Varna, Bulgaria

Tudogyintezete Nodradgardony; 🇭🇺 Balassagyarmat, Hungary

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