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Tiotropium (Spiriva) Rehabilitation Study

NCT ID: NCT00274521

Last Updated: 2013-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-05-31

Brief Summary

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The study was designed to determine whether tiotropium inhalation capsules, compared to placebo, enhances the improvement in exercise tolerance seen in patients with chronic obstructive pulmonary disease (COPD) who participate in pulmonary rehabilitation. In addition, assessments of the effect of tiotropium on dyspnea and quality of life following pulmonary rehabilitation were taken.

Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Tiotropium

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

History of COPD, FEV1 of less than or equal than 60% of predicted normal and less than or equal to 70% at Visit 1, Male or Female 40 years or greater, smoking history of more than 10 pack years (current or ex-smokers), patient can perform all study related tests, patients can inhale medication from HandiHaler and from meter dose inhaler, patients who would benefit from participation in a pulmonary rehab program and patients who had a medical clearance to participate in a pulmonary rehab program.

Exclusion Criteria

Patients with significant diseases other than COPD, patients with clinically relevant abnormal baseline hematology, blood chemistry or urinalysis, all patients with SGOT greater than 80IU/L, bilirubin greater than 2.0 mg/dl or creatinine greater than 2.0 mg/dL, recent history of MI (6 months or less). any cardiac arrhythmia requiring drug therapy or has abeen hospitalized for heart failure with the past 3 years, active TB, history of CA or had treatment within the last 24 months, history of CF, bronchiectasis, interstitial lung disease or pulmonary thromboembolic disease.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Principal Investigators

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Boehringer Ingelheim Study Coordinator

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

Site Status

Attention: John E. Hodgkin, M.D.

Deer Park, California, United States

Site Status

Boehringer Ingelheim Investigational Site

Long Beach, California, United States

Site Status

UCLA School of Medicine

Los Angeles, California, United States

Site Status

Boehringer Ingelheim Investigational Site

San Diego, California, United States

Site Status

Harbor-UCLA Research and Education Institute

Torrance, California, United States

Site Status

Boehringer Ingelheim Investigational Site

Fort Collins, Colorado, United States

Site Status

Boehringer Ingelheim Investigational Site

Wheat Ridge, Colorado, United States

Site Status

Boehringer Ingelheim Investigational Site

Danbury, Connecticut, United States

Site Status

St. Francis Hospital and Medical Center

Hartford, Connecticut, United States

Site Status

Norwalk Hospital

Norwalk, Connecticut, United States

Site Status

Boehringer Ingelheim Investigational Site

Elk Grove Village, Illinois, United States

Site Status

UMass Memorial Medical Center

North Worcester, Massachusetts, United States

Site Status

Henry Ford Hospital

Detroit, Michigan, United States

Site Status

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

Duke University Medical Center

Durhan, North Carolina, United States

Site Status

Temple University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Boehringer Ingelheim Investigational Site

Everett, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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205.230

Identifier Type: -

Identifier Source: org_study_id