Tiotropium (Spiriva) Rehabilitation Study

Completed · Phase 3

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

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.

Key facts

Study ID

NCT00274521

Run by

Boehringer Ingelheim

People needed

108

Starts

2001-05-01

Last updated by the study team

2013-11-01

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Boehringer Ingelheim Investigational Site — Phoenix, Arizona, United States
• Attention: John E. Hodgkin, M.D. — Deer Park, California, United States
• Boehringer Ingelheim Investigational Site — Long Beach, California, United States
• UCLA School of Medicine — Los Angeles, California, United States
• Boehringer Ingelheim Investigational Site — San Diego, California, United States
• Harbor-UCLA Research and Education Institute — Torrance, California, United States
• Boehringer Ingelheim Investigational Site — Fort Collins, Colorado, United States
• Boehringer Ingelheim Investigational Site — Wheat Ridge, Colorado, United States
• Boehringer Ingelheim Investigational Site — Danbury, Connecticut, United States
• St. Francis Hospital and Medical Center — Hartford, Connecticut, United States
• Norwalk Hospital — Norwalk, Connecticut, United States
• Boehringer Ingelheim Investigational Site — Elk Grove Village, Illinois, United States
• UMass Memorial Medical Center — North Worcester, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Duke University Medical Center — Durhan, North Carolina, United States
• Temple University Hospital — Philadelphia, Pennsylvania, United States
• Boehringer Ingelheim Investigational Site — Everett, Washington, United States

Full record on ClinicalTrials.gov

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