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Effects of Cardioselective β-blockers on Dynamic Hyperinflation in COPD

NCT01273298 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2011-06-23

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Bisoprolol

Patients will be assigned to bisoprolol per os or matching placebo per os daily for 14 days. Bisoprolol will be initiated at a dose of 2.5mg daily for the first two days then up-titrated to 5mg daily for two other days. And finally, bisoprolol will be up-titrated to 10mg daily for the remaining 10 days.

DRUG

Placebo

Patients will be assigned to bisoprolol per os or matching placebo per os daily for 14 days. Bisoprolol will be initiated at a dose of 2.5mg daily for the first two days then up-titrated to 5mg daily for two other days. And finally, bisoprolol will be up-titrated to 10mg daily for the remaining 10 days.

Sponsors & Collaborators

  • Laval University

    lead OTHER

Principal Investigators

  • Steeve Provencher, MD, M.Sc · Laval University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2010-09-30
Completion
2010-10-31

Countries

  • Canada

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01273298 on ClinicalTrials.gov