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Clinical Trials/NCT00308191
NCT00308191
Completed
Phase 3

A 6-Week Double-Blind, Parallel-Group, Active-Controlled Trial to Compare the Efficacy and Safety of Concomitant Treatment of Formoterol Fumarate Inhalation Solution 20 Mcg Twice Daily and Tiotropium 18 Mcg Once Daily to Tiotropium 18 Mcg Once Daily Alone in the Treatment of Patients With Chronic Obstructive Pulmonary Disease

Dey1 site in 1 country128 target enrollmentApril 2006

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
COPD
Sponsor
Dey
Enrollment
128
Locations
1
Primary Endpoint
Measure of lung Function
Status
Completed
Last Updated
18 years ago

Overview

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of the concomitant treatment of formoterol fumarate with tiotropium bromide compared to treatment with tiotropium bromide alone.

Registry
clinicaltrials.gov
Start Date
April 2006
End Date
December 2006
Last Updated
18 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
  • Significant condition or disease other than COPD

Outcomes

Primary Outcomes

Measure of lung Function

Secondary Outcomes

  • Change in lung function, vital signs; physical examinations; clinical laboratory assessments; adverse event reporting; patient questionnaires

Study Sites (1)

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