Status:
COMPLETED
Tiotropium (Spiriva) Rehabilitation Study
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
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 dise...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2001
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00274521
Start Date
May 1 2001
Last Update
November 1 2013
Active Locations (19)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States
2
Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
3
Attention: John E. Hodgkin, M.D.
Deer Park, California, United States
4
Boehringer Ingelheim Investigational Site
Long Beach, California, United States