Tiotropium (Spiriva) Rehabilitation Study

Study Overview
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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.

Official Title
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A Randomized, Double-blind, Placebo Controlled 25-week Trial to Compare the Effect of Tiotropium Inhalation Capsuled (18 Mcg) Once Daily on Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease (COPD) Participating in 8 Weeks of Pulmonary Rehabilitation.

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Drug: Tiotropium


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tiotropium|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Individual FEV1 measurement |  | week 4, 13, 25 | 
| Individual FVC measurement |  | week 4, 13, 25 | 
| St. George.s Hospital Respiratory Questionnaire (SGRQ) |  | week 4, 13, 25 | 
| Transition dyspnea index |  | week 4, 13, 25 | 
| COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest) |  | week 4, 13, 25 | 
| Modified Borg scale |  | week 4, 13, 25 | 
| Amount of albuterol therapy used during the treatment period |  | 25 weeks | 
| Number and length of exacerbations of COPD |  | 25 weeks | 
| Physician's global evaluation |  | week 4, 13, 25 | 
| 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 | 
| Change in submaximal exercise tolerance prior to and after pulmonary rehabilitation. |  | week 13 | 
| Occurrence of adverse events |  | 25 weeks | 
| Pulse rate and blood pressure in conjunction with spirometry |  | 25 weeks | 
| Changes in the physical examination from baseline and at the conclusion of patient participation in the trial |  | 25 weeks |