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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Region Oerebro Laen

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

completed 19 Nov 2025

Decision date (initial)

2024-07-09

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-512407-39-00

EudraCT number

2017-001507-76

ClinicalTrials.gov

NCT03566667

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis

To investigate whether beta-blocker treatment to patients with COPD and no co-existing cardiovascular disease protects against exacerbations of COPD, cardiovascular events and death

Conditions and MedDRA coding

Chronic obstructive pulmonary disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. 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
2. ≥40 years of age
3. Sinus rhythm ≥50/min and <120 at inclusion
4. Written informed consent

Exclusion criteria 17

1. Known hypersensitivity to metoprolol or related derivatives
2. AV block II or III unless treated with a pacemaker
3. Sinus bradycardia (resting heart rate <50/min)
4. Sick sinus syndrome unless treated with a pacemaker
5. Atrial fibrillation/flutter (AF)
6. 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
7. Systolic blood pressure <90 mmHg
8. Any tachyarrythmias other than sinus rhythm
9. Sinustachycardia >120 / min
10. Systolic blood pressure <90 mmHg
11. Severe bronchial asthma
12. Current beta-blocker treatment
13. Inability to provide informed consent
14. Age below 40 years
15. Acute on-going exacerbation of COPD
16. Previous randomization in the BRONCHIOLE trial
17. Ongoing pregnancy (excluded by pregnancy test in fertile women)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. A composite of time to death, exacerbations of COPD, and cardiovascular events (myocardial infarction, angina pectoris, heart failure, stroke, transient ischemic attack, or cerebral hemorrhage) recorded in the Swedish National Patient Register or in electronic primary care records (ICD codes I20, I21,122, I48, I50.1-9, I61, I63 or G45.9)

Secondary endpoints 4

1. Time to death (all-cause and cause-specific)
2. Time to exacerbation of COPD
3. Time to a cardiovascular event
4. Extensive health-economic analysis

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Oerebro Laen

Sponsor organisation

Region Oerebro Laen

Address

Sodra Grev Rosengatan

City

Orebro

Postcode

701 85

Country

Sweden

Scientific contact point

Organisation

Region Oerebro Laen

Contact name

Josefin Sundh

Public contact point

Organisation

Region Oerebro Laen

Contact name

Josefin Sundh

Locations

1 EU/EEA country · 20 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications