Cardiac Limitations in Chronic Obstructive Pulmonary Disease: Benefits of Bronchodilation
Completed · Phase 4 · Has a placebo group
Conditions studied: Chronic Obstructive Pulmonary Disease, COPD
In brief
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).
Key facts
- Study ID
- NCT00578968
- Run by
- Mayo Clinic
- People needed
- 36
- Starts
- 2006-10-01
- Expected to finish
- 2008-08-01
- Last updated by the study team
- 2012-06-26
Who can join
Age: 35 and older, up to 85. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Mayo Clinic — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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