An 8 Week Randomized, Placebo Controlled, Double-blind Study to Assess the Efficacy of Tiotropium Inhalation Capsules in Patients of African Descent With Chronic Obstructive Pulmonary Disease

Boehringer Ingelheim16 sites in 1 country166 target enrollmentJune 2004

ConditionsPulmonary Disease, Chronic Obstructive

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Enrollment: 166
Locations: 16
Primary Endpoint: The primary efficacy endpoint will be FEV1 AUC (0-3) after 8 weeks of treatment
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to look at the benefits of tiotropium, an approved drug for the treatment of bronchospasm associated with COPD (chronic obstructive pulmonary disease), in a population of patients with COPD who are of African American descent.

Registry

clinicaltrials.gov

Start Date

June 2004

End Date

August 2005

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Eligibility Criteria

Inclusion Criteria

•Male or female of African descent
•40 years of age or older
•Diagnosis of COPD
•History of smoking at least one pack per day for at least 10 years
•Currently experiencing shortness of breath at least with exertion

Exclusion Criteria

•Recent myocardial infarction or hospitalization for congestive heart failure

Outcomes

Primary Outcomes

The primary efficacy endpoint will be FEV1 AUC (0-3) after 8 weeks of treatment

Secondary Outcomes

FEV1 AUC0-3 after single dose, 4 weeks of treatment, peak FEV1 on each test day, trough FEV1 at weeks 4 & 8, FVC trough (weeks 4 & 8), peak and AUC(0-3) (on all test days), FEV1 and FVC at all time points, rescue albuterol use, dyspnea SOP questionnaire