SLCTR/2021/033RecruitingPhase 3
Preventing Adverse Cardiac Events (PACE) in Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
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.
Investigators
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