Principal Investigator:  Christopher B. Cooper, M.D., F.C.C.P.

Pocket Guide For Physicians

• Multicenter, randomized clinical trial.
• To test the efficacy and safety of an inhalant capsule which enhances the improvement in exercise tolerance within COPD patients participating in pulmonary rehabilitation.
• Subjects will take Tiotropium, 18 mcg of an oral inhalant once daily, or a placebo for 25 weeks.

Inclusion Criteria

• Male or female 40 years of age or older.
• COPD with FEV₁ less than 60% of predicted and FEV₁/FVC ratio less than 70%.
• Functionally semi-independent.
• Current or ex-smoker, at least 10 pack years. (equivalent to 1pk/day for 10 years)
• Ability to participate in aerobic exercise and testing.

Exclusion Criteria

• Frequent COPD exacerbations requiring hospitalization.
• Participation in a pulmonary or cardiac rehabilitation program within past year.
• Being treated with anithistamines, cromolyn-sodium, or nedocromil-sodium.
• Using oral coritcosteriod medication at unstable doeses or in excess of equvalent of 10mg prednisone/day.
• Diagnosis of cancer within last 2 years (except basal cell carcinoma).
• History of another serious lung disease or allergy.
• Respiratory infection within 6 weeks of Screening Visit or during run in period.
• MI within last 6 months, cardiac arrhythmias requiring medication, health failure with hospitalization within 3 years.
• Symptomatic prostatic hypertrophy, or bladder neck obstruction.
• Any clinically significant disease other than COPD.
• Current participation in any other clinical trial or use of any investigational drug within one month or six half lives prior to Screening Visit. 

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