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

Dey128 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

128

Conditions

COPD

Interventions

Formoterol FumarateDRUG

Tiotropium BromideDRUG

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (17)

Research Site

Phoenix, Arizona, United States

Research Site

Los Angeles, California, United States

Research Site

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

Data from ClinicalTrials.gov

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