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A Phase IIIB Study to Compare the Efficacy and Safety of Concomitant Treatment in Patients With COPD

Phase 3
Completed
Conditions
COPD
Registration Number
NCT00308191
Lead Sponsor
Dey
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
128
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Measure of lung Function
Secondary Outcome Measures
NameTimeMethod
Change in lung function, vital signs; physical examinations; clinical laboratory assessments; adverse event reporting; patient questionnaires

Trial Locations

Locations (1)

Research Site

🇺🇸

San Antonio, Texas, United States

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