Beta-blockeRs tO patieNts with CHronIc Obstructive puLmonary diseasE (BRONCHIOLE)

Phase 1

• Conditions: Chronic Obstructive Pulmonary disease; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2017-001507-76-SE
• Lead Sponsor: Region Örebro län

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-08
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1700

Inclusion Criteria

A diagnosis of COPD confirmed by spirometry showing post bronchodilator value of Forced Expiratory Volume in one second (FEV1)//Forced Vital Capacity (FVC) < 70 according to the Global Initiative on Obstructive Pulmonary Disease (GOLD), and with a history of tobacco smoking or occupational/environmental exposure for smoke gas or dust
And:
- =40 years of age.
- Sinus rhythm =50/min and <120 at inclusion.
- Written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1100

Exclusion Criteria

- Known hypersensitivity to metoprolol or related derivatives.
- AF or other arrhythmias for which beta blockers are indicated according to
the investigator discretion.
- AV block II or III unless treated with a pacemaker.
- Sinus bradycardia (resting heart rate <50/min).
- Sick sinus syndrome unless treated with a pacemaker.
- Clinical signs of or a previous diagnosis of HF.
- Systolic blood pressure <90 mmHg.
- Severe bronchial asthma.
- Current beta-blocker treatment.
- Inability to provide informed consent.
- Age below 40 years.
- Acute on-going exacerbation of COPD.
- Previous randomization in the BRONCHIOLE trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified