Tiotropium (Spiriva) Rehabilitation Study
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Registration Number
- NCT00274521
- Lead Sponsor
- Boehringer Ingelheim
- 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 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 108
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The primary endpoint is the change in submaximal exercise tolerance (prior to treatment to after pulmonary rehabilitation) as measured by endurance time during a constant work rate treadmill exercise test at 80% of maximum work capacity week 13
- Secondary Outcome Measures
Name Time Method Individual FEV1 measurement week 4, 13, 25 Amount of albuterol therapy used during the treatment period 25 weeks Number and length of exacerbations of COPD 25 weeks Patient peak flow rates twice daily 25 weeks Patient activity measurement week 9, 13, 17, 21, 25 Change in submaximal exercise tolerance during constant work rate exercise week 25 Individual FVC measurement week 4, 13, 25 St. George.s Hospital Respiratory Questionnaire (SGRQ) week 4, 13, 25 Modified Borg scale week 4, 13, 25 Transition dyspnea index week 4, 13, 25 Pulse rate and blood pressure in conjunction with spirometry 25 weeks Physician's global evaluation week 4, 13, 25 COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest) week 4, 13, 25 Change in submaximal exercise tolerance prior to and after pulmonary rehabilitation. week 13 Occurrence of adverse events 25 weeks Changes in the physical examination from baseline and at the conclusion of patient participation in the trial 25 weeks
Trial Locations
- Locations (12)
Harbor-UCLA Research and Education Institute
🇺🇸Torrance, California, United States
St. Francis Hospital and Medical Center
🇺🇸Hartford, Connecticut, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Attention: John E. Hodgkin, M.D.
🇺🇸Deer Park, California, United States
UCLA School of Medicine
🇺🇸Los Angeles, California, United States
Boehringer Ingelheim Investigational Site
🇺🇸Everett, Washington, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Norwalk Hospital
🇺🇸Norwalk, Connecticut, United States
UMass Memorial Medical Center
🇺🇸North Worcester, Massachusetts, United States
Duke University Medical Center
🇺🇸Durhan, North Carolina, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States