Study in Patients With COPD

Phase 3

Completed

• Conditions: COPD

• Registration Number: NCT00215449
• Lead Sponsor: Dey

Brief Summary

The purpose of this study is to determine the efficacy and safety of the investigational drug in the treatment of COPD in comparison with a placebo.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-22
• Primary Completion: 2005-12
• Study Completion: 2006-04
• Status Verified: 2009-01
• Last Update Submitted: 2010-11-10
• Last Update Posted: 2010-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 690

Inclusion Criteria

• Medical diagnosis of COPD
• Current or prior history of cigarette smoking

Exclusion Criteria

• Medical diagnosis of asthma
• Chest x-ray (CXR) prior to Day 1 diagnostic of significant disease other than COPD
• Significant condition or disease other than COPD

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Measure of lung function

Secondary Outcome Measures

Name	Time	Method
Change in lung function, as well as vital signs
Physical Exam results, Adverse Event reporting, etc

Trial Locations

Locations (1)

Research Site; 🇺🇸 Milwaukee, Wisconsin, United States