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)
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.
Beta-blockers are indicated in the management of numerous medical conditions including
angina pectoris, myocardial infarction, hypertension, congestive heart failure, cardiac
arrhythmia, systemic hypertension, as well as to reduce complications in the perioperative
period. Patients with chronic obstructive pulmonary disease (COPD) are at greater risk of
such conditions and may therefore benefit from the use of beta-blockers. Despite clear
evidence of their effectiveness, clinicians are often hesitant to administer beta-blockers
in COPD patients for fear of adverse effects on lung function. Indeed, the pathophysiologic
hallmark of COPD is expiratory flow limitation. Because beta-adrenergic receptors
participate to bronchial dilatation, review articles and practice guidelines traditionally
listed asthma and COPD as relative contraindications to beta-blocker use, citing cases of
acute bronchospasm occurring during beta-blocker exposure.
However, cardioselective betablockers have over 20 times more affinity for beta-1 receptors
as for beta-2 receptors, and theoretically should have significantly less risk for
bronchoconstriction. Cardioselective beta-blockers include atenolol, metoprolol, bisoprolol
and acebutolol. A recent Cochrane analysis documented the safety of cardioselective
beta-blockers in COPD. Indeed, single doses of cardioselective beta-blockers as well as
treatment of longer duration ranging from 2 days to 12 weeks led to a non-significant
worsening in lung function compared to placebo. Expiratory flow limitation is commonly
assessed by forced expiratory volume in one second (FEV1). However, the FEV1 appears to be a
crude estimate bronchial obstruction in COPD. Indeed, the relationship between the
physiologic impairment, as traditionally measured by FEV1, and the characteristic symptom of
COPD is not straightforward. Dyspnea appears to be more related to dynamic hyperinflation
occurring during exercise than to FEV1 measured at rest. Lung hyperinflation is defined as
an abnormal increase in the volume of air remaining in the lungs at the end of spontaneous
expiration. For example, bronchodilators, which generally have minimal effect on FEV1 in
COPD, work by improving dynamic airway function, allowing improved lung emptying with each
breath. This allows the patient to achieve the required alveolar ventilation during rest and
exercise at a lower operating lung volume and thus at a lower oxygen cost of breathing.
Exercise can proceed for a longer duration before the mechanical limitation to ventilation
is reached. Changes in dynamic hyperinflation are thus representative of subtle changes in
bronchial obstruction. Importantly, the effects of cardioselective beta-blockers on dynamic
hyperinflation, a subtle marker of bronchial obstruction, remain unknown.
The aim of this prospective, randomized, double blind and crossover study is to assess the
effects of short-term cardioselective beta-blocker therapy on dynamic hyperinflation and on
exercise tolerance and symptoms in patients with moderate-to-severe COPD.
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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