Beta-blockeRs tO patieNts with CHronIc Obstructive puLmonary diseasE (BRONCHIOLE) - Study protocol from a randomized...

Area of Science:

• Pulmonary Medicine
• Cardiology
• Clinical Trials

Background:

• Observational studies suggest beta-blockers reduce exacerbations and mortality in COPD patients, even without diagnosed cardiovascular disease.
• Randomized controlled trial (RCT) data are currently lacking to confirm these benefits.
• The BRONCHIOLE study addresses this gap by evaluating beta-blocker efficacy in this patient population.

Purpose of the Study:

• To investigate the 1-year risk of a composite endpoint including death, COPD exacerbations, and cardiovascular events in COPD patients treated with beta-blockers.
• To assess the efficacy of metoprolol in patients with COPD but without diagnosed cardiovascular disease.

Main Methods:

• The Beta-blockeRs tO patieNts with CHronIc Obstructive puLmonary diseasE (BRONCHIOLE) study is a prospective, multicenter, open-label RCT.
• 1700 patients with COPD will be randomized to receive standard care plus metoprolol (100 mg/day) or standard care alone.
• Exclusion criteria include ischemic heart disease, heart failure, cerebrovascular disease, critical limb ischemia, and atrial fibrillation/flutter.

Main Results:

• The primary endpoint is a composite of death, COPD exacerbations, and cardiovascular events.
• Data collection involves medical history review, record analysis, and national registries.
• The trial is registered on ClinicalTrials.gov (ID: NCT03566667).

Conclusions:

• The BRONCHIOLE study is a pragmatic RCT designed to evaluate the role of beta-blockers in COPD management.
• It is expected to yield significant clinical data on the impact of beta-blocker therapy on patient-related outcomes in COPD.
• The findings will inform clinical practice regarding the use of beta-blockers in COPD patients without overt cardiovascular disease.