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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00106821

Enrollment

166

Registered

2005-04-01

Start date

2004-06-30

Completion date

Unknown

Last updated

2013-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive

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.

Interventions

DRUGTiotropium Bromide Inhalation Powder

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026