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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
CTIS2024-512407-39-00
Lead Sponsor
Region Oerebro Laen
Brief Summary

Not available

Detailed Description

Not available

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, =40 years of age, Sinus rhythm =50/min and <120 at inclusion, Written informed consent

Exclusion Criteria

Known hypersensitivity to metoprolol or related derivatives, 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, Ongoing pregnancy (excluded by pregnancy test in fertile women), 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, Atrial fibrillation/flutter (AF), Clinical signs of or a previous diagnosis of left-sided heart failure (HF), angina pectoris (AP), myocardial infarction (MI), cerebrovascular disease or critical peripheral ischemia, Systolic blood pressure <90 mmHg, Any tachyarrythmias other than sinus rhythm, Sinustachycardia >120 / min

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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