Effects of Cardioselective β-blockers on Dynamic Hyperinflation in COPD

NCT01273298 | Completed

• 1 other identifier: BB-MPOC-UL
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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

Chronic Obstructive Pulmonary Disease

Keywords

chronic obstructive pulmonary disease; exercise; dynamic hyperinflation; cardioselective beta blockers

Outcome Measures

Primary Outcomes (1)

• Dynamic hyperinflation

  Dynamic hyperinflation assessed during a cycle endurance test

  14 days

Secondary Outcomes (3)

• Exercise tolerance

  14 days

• Respiratory symptoms during exercise

  14 days

• Resting lung function

  14 days

Study Arms (2)

Bisoprolol

EXPERIMENTAL

Drug: Bisoprolol

Sugar pill

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Bisoprolol DRUG

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.

Also known as: Monocor (02241148)

Bisoprolol

Placebo DRUG

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.

Also known as: Sugar pill

Sugar pill

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec (CRIUCPQ)

Québec, Quebec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Interventions

Bisoprolol; Sugars

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbohydrates

Study Officials

• Steeve Provencher, MD, M.Sc

  Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 24, 2010
• First Posted: January 10, 2011
• Study Start: June 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: October 1, 2010
• Last Updated: June 23, 2011

Record last verified: 2010-11

Locations

CA (1)