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Clinical Trials/NCT00215436
NCT00215436
Completed
Phase 3

A 12-week Double-Blind, Parallel-Group, Placebo- and Active- Controlled Trial to Evaluate the Efficacy and Safety of Formoterol Fumarate Inhalation Solution 20 Mcg in the Treatment of Patients With Chronic Obstructive Pulmonary Disease

Dey1 site in 1 country345 target enrollmentMarch 2005

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
COPD
Sponsor
Dey
Enrollment
345
Locations
1
Primary Endpoint
Measure of lung function
Status
Completed
Last Updated
15 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
March 2005
End Date
September 2006
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Dey

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Medical diagnosis of asthma
  • Chest X-ray diagnostic of significant disease other than COPD
  • Significant condition or disease other than COPD

Outcomes

Primary Outcomes

Measure of lung function

Secondary Outcomes

  • Change in lung function, as well as vital signs
  • Physical Exam results, Adverse event reporting, etc

Study Sites (1)

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