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.

Preventing Adverse Cardiac Events (PACE) in Chronic Obstructive Pulmonary Disease (COPD)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2021/033

Enrollment

Unknown

Registered

2021-11-19

Start date

2021-12-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory disease

Interventions

Study Setting: National Hospital Sri Lanka, Colombo 08 National Hospital for Respiratory Diseases, Welisara Kandy National Hopital, Kandy This is a Phase III, randomized, double blind, placebo control

Eligibility

Inclusion 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

Exclusion criteria: 1. Concurrent therapy with any other –? blocker 2. Resting heart rate (HR) 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.

Design outcomes

Primary

Measure	Time frame
All-cause mortality [Baseline to 24 months] Hospitalisation for COPD exacerbation [ Baseline to 24 months] Hospitalisation for primary cardiac cause (ischaemia, arrhythmia or heart failure) [ Baseline to 24 months] 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]	—

Measure

Time frame

All-cause mortality [Baseline to 24 months] Hospitalisation for COPD exacerbation [ Baseline to 24 months] Hospitalisation for primary cardiac cause (ischaemia, arrhythmia or heart failure) [ Baseline to 24 months] 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]

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Secondary

Measure	Time frame
COPD exacerbation rate (annualised) Exacerbations will be defined as worsening respiratory symptoms resulting in treatment with antibiotics or systemic glucocorticoids. Exacerbation severity will be graded (secondary outcome) according to the following scale: i. moderate (requiring oral corticosteroids, antibiotics or both without hospital admission) ii. severe (requiring above treatment and hospital admission) [Baseline to 24 months ] Time to first moderate-severe COPD Exacerbation [Baseline to 24 months ] Severe (hospital admission) COPD exacerbation rate (annualised) [Baseline to 24 months] Number of events of composite (annualised) cardio-respiratory hospital admissions and MACE. [Baseline to 24 months] Quality of life assessed by St George's Respiratory Questionnaire (SGRQ) The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction. Scores are calculated for three domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. Psychometric testing has demonstrated its repeatability, reliability and validity. Sensitivity has been demonstrated in clinical trials. A minimum change in score of 4 units was established as clinically relevant after patient and clinician testing. The SGRQ has been used in a range of disease groups including asthma, chronic obstructive pulmonary disease (COPD) and bronchiectasis, and in a range of settings such as randomised controlled therapy trials and population surveys. [Baseline to 24 months] EuroQoL Group 5-5 Dimension self-report questionnaire (EQ-5D-5L) to assess health state utilities EQ-5D-5L consists of 2pg: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). Five dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension 5 levels: no problems, slight problems, moderate problems, severe problems, extreme problems. Patient indicates their health state by ticki	—

Measure

Time frame

COPD exacerbation rate (annualised) Exacerbations will be defined as worsening respiratory symptoms resulting in treatment with antibiotics or systemic glucocorticoids. Exacerbation severity will be graded (secondary outcome) according to the following scale: i. moderate (requiring oral corticosteroids, antibiotics or both without hospital admission) ii. severe (requiring above treatment and hospital admission) [Baseline to 24 months ] Time to first moderate-severe COPD Exacerbation [Baseline to 24 months ] Severe (hospital admission) COPD exacerbation rate (annualised) [Baseline to 24 months] Number of events of composite (annualised) cardio-respiratory hospital admissions and MACE. [Baseline to 24 months] Quality of life assessed by St George's Respiratory Questionnaire (SGRQ) The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction. Scores are calculated for three domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. Psychometric testing has demonstrated its repeatability, reliability and validity. Sensitivity has been demonstrated in clinical trials. A minimum change in score of 4 units was established as clinically relevant after patient and clinician testing. The SGRQ has been used in a range of disease groups including asthma, chronic obstructive pulmonary disease (COPD) and bronchiectasis, and in a range of settings such as randomised controlled therapy trials and population surveys. [Baseline to 24 months] EuroQoL Group 5-5 Dimension self-report questionnaire (EQ-5D-5L) to assess health state utilities EQ-5D-5L consists of 2pg: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). Five dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension 5 levels: no problems, slight problems, moderate problems, severe problems, extreme problems. Patient indicates their health state by ticki

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Countries

Australia,India,New Zealand

Contacts

Public ContactProf. Channa Ranasinha

Specialist Chest Physician

Channa.ranasinha@gmail.com+94 11 296 1139

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026