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

This study has been completed.

Sponsor:

Information provided by:

Boehringer Ingelheim Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00106821

First received: March 31, 2005

Last updated: May 18, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

March 31, 2005

Last Updated Date

May 18, 2012

Start Date ^ICMJE

June 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00106821 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Pulmonary Disease, Chronic Obstructive

Intervention ^ICMJE

Drug: Tiotropium Bromide Inhalation Powder

Study Arm (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

180

Completion Date

January 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

40 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00106821

Other Study ID Numbers ^ICMJE

205.294

Has Data Monitoring Committee

Responsible Party

Study Sponsor ^ICMJE

Boehringer Ingelheim Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Boehringer Ingelheim Study Coordinator

Boehringer Ingelheim Pharmaceuticals

Information Provided By

Boehringer Ingelheim Pharmaceuticals

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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