A double-blind, placebo controlled, randomised trial in participants with COPD to assess the efficacy of proactive treatment with bisoprolol of cardiac risk in people with COPD.

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: Not specified

Inclusion Criteria

1.Have provided written informed consent
2.Have COPD defined by the 2019 Global Initiative for Chronic Obstructive Lung Disease (GOLD) diagnostic criteria
3.Aged 40-85 years (both male and female)
4.Forced Expiratory Volume in one second (FEV1) ?30% and ?70% predicted post-bronchodilator
5.FEV1/Forced Vital Capacity (FVC) <0.7 post-bronchodilator
6.Have had a COPD exacerbation in the previous 12 months requiring oral corticosteroid, antibiotics, or both
7.If taking maintenance oral corticosteroids (OCS), dosage is stable and ?10mg daily for 4 weeks prior to randomisation
8.Resting systolic blood pressure (SBP) ?100mmHg
9.SBP and spirometry criteria must be met after the test dose of bisoprolol of 1.25mg.

Exclusion Criteria

1. Concurrent therapy with any other –? blocker
2. Resting heart rate (HR) <60bpm
3. Unstable left HF (i.e. symptomatic and/or necessary change in management in the last 12 weeks, or in investigator’s opinion)
4. Clinically significant pulmonary hypertension, which in the investigator’s opinion would be a contra-indication for ? -blocker therapy
5. Severe end-stage peripheral vascular disease
6. 2nd or 3rd degree heart block
7. Currently using or have been prescribed long-term oxygen therapy (LTOT) or resting saturated oxygen level <90% when stable
8. Expected survival is less than 12 months, or in the investigator’s opinion, the person has such unstable disease (of any type) that maintaining 12 months’ participation would be unlikely
9. Clinical instability since a major adverse cardiac event (MACE) in the previous 12 weeks
10. Lower respiratory tract infection or AECOPD within the last 4 weeks
11. COPD not clinically stable as determined by the investigator
12. In the investigator’s opinion, have asthma-COPD overlap or co-existent asthma are present; or an improvement in FEV1 ? 400mL post-bronchodilator is observed on two occasions
13. Females of child-bearing age and capability who are pregnant or breastfeeding or those in this group not using adequate birth control
14. Coexistent illness which precludes participation in the study (e.g. poorly controlled diabetes, active malignancy)
15. Severe end-stage liver disease defined by INR>1.3 and albumin<30g/L or portal hypertension/ascites
16. High chance in the opinion of the investigator that the potential participant will not adhere to study requirements.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause mortality [Baseline to 24 months]<br> Hospitalisation for COPD exacerbation<br> [ Baseline to 24 months]<br> Hospitalisation for primary cardiac cause (ischaemia, arrhythmia or heart failure) [ Baseline to 24 months]<br>Major Adverse Cardiovascular Event (MACE). Major Adverse Cardiovascular Event (MACE) includes myocardial infarction, sudden death, cardiac death or a fatal event in system organ classes for cardiac and vascular disorders, and serious and non-serious stroke. [ Baseline to 24 months]<br>

Secondary Outcome Measures