Preventing Adverse Cardiac Events in COPD

Korábbi kezelés

• Concurrent therapy with any other β-blocker
• Currently using or have been prescribed LTOT or resting saturated oxygen level <90% when stable
• Clinical instability since a MACE in the previous 12 weeks

Más betegség

• Clinically significant pulmonary hypertension, which in the investigator's opinion would be a contraindication for β-blocker therapy
• Severe end-stage peripheral vascular disease
• 2nd or 3rd degree heart block
• 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
• Lower respiratory tract infection or AECOPD within the last 8 weeks
• Coexistent illness which precludes participation in the study (poorly controlled diabetes, active malignancy)

Laborértékek

• Severe end-stage liver disease defined by INR>1.3 and albumin<30g/L or portal hypertension/ascites

Életkor

• Females of child-bearing age and capability who are pregnant or breastfeeding or those in this group not using adequate birth control

Egyéb

• Participants will be ineligible for the study if they have any of the following:
• Resting HR <60bpm
• Unstable left HF (i.e. symptomatic and/or necessary change in management in the last 12 weeks, or in clinicians' opinion)
• COPD not clinically stable as determined by the investigator
• In the clinician's view, have asthma-COPD overlap or co-existent asthma are present; or an improvement in FEV1 ≥400mL post-bronchodilator is observed on two occasions
• High chance in the view of the treating physician that the potential participant will not adhere to study requirements

• Participants will be eligible for this study if they qualify on all of the following:
• Have provided written informed consent
• Have COPD defined by the 2019 Global Initiative for Chronic Obstructive Lung Disease (GOLD) diagnostic criteria
• Aged 40-85 years
• FEV1 ≥30% and ≤70% predicted post-bronchodilator
• FEV1/FVC <0.7 post-bronchodilator
• Have had a COPD exacerbation in the previous 24 months requiring oral corticosteroid, antibiotics, or both
• If taking maintenance OCS, dosage is stable and ≤10mg daily for 4 weeks prior to randomisation
• Resting SBP ≥100mmHg
• SBP and spirometry criteria must be met after the test dose of bisoprolol of 1.25mg
• (New Zealand only) A history of cardiovascular disease, including heart failure, ischaemic heart disease, tachyarrhythmias, and hypertension