Cardiac Limitations in Chronic Obstructive Pulmonary Disease: Benefits of Bronchodilation

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is being done to examine the influence of Tiotropium (good or bad) on heart function at rest and during exercise in patients with moderate to severe chronic obstructive pulmonary disease (COPD).

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mayo Clinic
• Collaborators: Boehringer Ingelheim; Pfizer
• Treatments: Tiotropium Bromide

Criteria

Chronic obstructive pulmonary disease (COPD) participants-

Inclusion criteria:

• Body Mass Index (BMI) <36

• Moderate to severe COPD patient, (similar to or slightly better than Gold Guidelines Stage 2-3, forced expiratory volume in one second [FEV_1] <60% of age predicted)

• Smoking history of 10 pack years or more

• Clinical diagnosis of COPD

• Not on daytime oxygen

Exclusion criteria:

• Clinical diagnosis of asthma

• Myocardial infarction within the last 6 months, or known ischemia

• Serious uncontrolled cardiac arrhythmia (i.e., atrial fibrillation or ventricular tachycardia) or hospitalization for heart failure within the previous year

• Known moderate to severe renal impairment

• Known moderate to severe symptomatic prostatic hypertrophy or bladder neck obstruction

• Known narrow angle glaucoma

• Current radiation or chemotherapy for a malignant condition

• Inability to give informed consent

• On systemic corticosteroids at unstable doses or on regular daily doses of 20 mg or more of prednisone (or equivalent)

• Not fully recovered from an exacerbation of COPD for at least 30 days

• Inability to perform light to moderate activity for orthopedic reasons or who significantly desaturated with exercise (percentage of available hemoglobin that is saturated with oxygen [SaO_2] < 85% on screening test

Healthy controls -

Inclusion:

• Age and gender matched to COPD participants

Exclusion:

• Subjects who are unable to engage in exercise testing due to existing comorbidities