Efficacy of Tiotropium in Patients of African Descent With Chronic Obstructive Pulmonary Disease

Boehringer Ingelheim166 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

166

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide Inhalation PowderDRUG

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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: * Asthma * Recent myocardial infarction or hospitalization for congestive heart failure

Locations (19)

Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Cooper Green Hospital

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

Data from ClinicalTrials.gov

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