Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Effects of Cardioselective Beta-blockers on Dynamic Hyperinflation in Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)
Verified date | November 2010 |
Source | Laval University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Interventional |
Patients with chronic obstructive pulmonary disease (COPD) are at greater risk of suffering from diseases for which beta-blockers may be indicated and effective. Clinicians remain hesitant to administer beta-blockers to COPD patients for fear of adverse effects on lung function. However, cardioselective beta-blockers therapy led to a non-significant worsening of resting expiratory flow limitation measured by the forced expiratory volume in one second (FEV1) as compared to placebo. But, the FEV1 appears to be a crude estimate bronchial obstruction in COPD. Importantly, the effects of cardioselective beta-blockers on dynamic hyperinflation, a subtle marker of bronchial obstruction, remain unknown. Thus, a prospective placebo-controlled study assessing the effects of short-term cardioselective beta-blocker therapy on dynamic hyperinflation in patients with moderate-to-severe COPD is needed.
Status | Completed |
Enrollment | 27 |
Est. completion date | October 2010 |
Est. primary completion date | September 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: - age: >50 years old; - cigarette exposure: >10 pack-year; - moderate-to-severe COPD (Forced expiratory volume in one second/Forced vital capacity (FEV1/FVC) <70%; FEV1 between 30 to 80% predicted). Exclusion Criteria: - previous bronchospasm induced by beta-blockers; - respiratory exacerbation in the previous 8 weeks; - long-term oxygen therapy or arterial oxygen saturation <85% at rest; - known coronary artery disease with persistent symptoms or persistent myocardial ischemia on cardiac imaging; - left ventricular ejection fraction <40%; - current treatment with oral corticosteroids; - intrinsic musculoskeletal abnormality precluding exercise testing; - medical condition for which the patient is currently treated with beta-blockers. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec (CRIUCPQ) | Québec | Quebec |
Lead Sponsor | Collaborator |
---|---|
Laval University |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dynamic hyperinflation | Dynamic hyperinflation assessed during a cycle endurance test | 14 days | No |
Secondary | Exercise tolerance | Exercise time during cycle endurance test | 14 days | No |
Secondary | Respiratory symptoms during exercise | Borg dyspnea and leg fatigue (0 to 10 scale) | 14 days | No |
Secondary | Resting lung function | Standard pulmonary function tests | 14 days | No |
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