Study to Evaluate the Effects of Tiotropium Bromide on Chronic Obstructive Pulmonary Disease (COPD) During Exercise

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effect of treatment with tiotropium bromide on efficiency of gas exchange and exercise performance in COPD subjects during exercise.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McMaster University
• Collaborator: Boehringer Ingelheim
• Treatments: Bromides; Tiotropium Bromide

Criteria

Inclusion Criteria:

• Patients must be current or ex-smokers with a cigarette smoking history of > 10 pack years.

• All patients must have a diagnosis of COPD.

• Patients maintained on a daily dose of inhaled corticosteroids need to be at a constant dose at 4 weeks prior to study entry.

Exclusion Criteria:

• Patients with significant diseases other than COPD.

• Patients with a history of a recent (i.e. six months or less) myocardial infarction.

• Patients with unstable or life threatening cardiac arrhythmias including any patient with a newly diagnosed, clinically relevant arrhythmia on the ECG performed on Visit 1.

• Patients who have been hospitalized for heart failure (NYHA class III or IV) within the past year.

• Patients with a history of life threatening pulmonary obstruction, or history of cystic fibrosis or clinically evident bronchiectasis.

• Patients who have undergone thoracotomy with pulmonary resection.

• Patients with any respiratory infection or exacerbation in the six weeks prior to Visit 1.

• Patients who regularly use daytime oxygen therapy for more than one hour per day and who in the investigator's opinion, will be unable to abstain from the use of oxygen therapy during testing.

• Patients who are currently in a pulmonary rehabilitation program or who have completed a pulmonary rehabilitation program within four weeks of Visit 1.

• Patients with known active tuberculosis.

• Patients with a history of cancer within the past five years.

• Pregnant or breastfeeding women or women of childbearing potential not using a medically approved means of contraception.

• Patients with known hypersensitivity to anti-cholinergic drugs, lactose or any other components of the inhalation capsule delivery system.

• Patients with a history of significant alcohol or drug abuse in the previous year.

• Patients with have taken an investigational drug within 30 days or 6 half lives (whichever is greater) prior to Visit 1.

• Patients using oral corticosteroid medication and unstable doses (i.e. less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg prednisone per day or 20 mg every other day.

• Patients who use rescue medication (Salbutamol) more than 8 puffs/day.

• Patients who have used tiotropium (Spiriva) within 4 weeks prior to Visit 1.

• Patients who have frequent exacerbations which could be expected to interfere with participation in the trial.