TY - JOUR
T1 - Preventing adverse cardiac events (PACE) in chronic obstructive pulmonary disease (COPD)
T2 - study protocol for a double-blind, placebo controlled, randomised controlled trial of bisoprolol in COPD
AU - Martin, Allison
AU - Hancox, Robert J.
AU - Chang, Catherina L.
AU - Beasley, Richard
AU - Wrobel, Jeremy
AU - McDonald, Vanessa
AU - Dobler, Claudia C.
AU - Yang, Ian A.
AU - Farah, Claude S.
AU - Cochrane, Belinda
AU - Hillis, Graham S.
AU - Scowcroft, Caroline Polak
AU - Aggarwal, Ashutosh
AU - Di Tanna, Gian Luca
AU - Balicki, Grace
AU - Galgey, Shane
AU - Jenkins, Christine
N1 - Copyright the Author(s) 2021. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.
PY - 2021/8/27
Y1 - 2021/8/27
N2 - Introduction Heart disease in chronic obstructive pulmonary disease (COPD) is a common but neglected comorbidity. Patients with COPD are frequently excluded from clinical trials of treatments aimed at reducing cardiac morbidity and mortality, which has led to undertreatment of cardiovascular disease in patients with COPD. A particular concern in COPD is the underuse of beta (β)-blockers. There is observational evidence that cardioselective β-blockers are safe and may even reduce mortality risk in COPD, although some evidence is conflicting. There is an urgent need to answer the research question: Are cardioselective β-blockers safe and of benefit in people with moderately severe COPD? The proposed study will investigate whether cardioselective β-blocker treatment in patients with COPD reduces mortality and cardiac and respiratory morbidity. Methods and analyses This is a double-blind, randomised controlled trial to be conducted in approximately 26 sites in Australia, New Zealand, India, Sri Lanka and other countries as required. Participants with COPD will be randomised to either bisoprolol once daily (range 1.25-5 mg, dependent on tolerated dose) or matched placebo, in addition to receiving usual care for their COPD over the study duration of 24 months. The study will enrol 1164 participants with moderate to severe COPD, aged 40-85 years. Participants will be symptomatic from their COPD and have a postbronchodilator forced expiratory volume in 1 s (FEV 1) ≥30% and ≤70% predicted and a history of at least one exacerbation requiring systemic corticosteroids, antibiotics or both in the prior 24 months. Ethics and dissemination The study protocol has been approved by the Sydney Local Health District Human Research Ethics Committee at The Concord Repatriation General Hospital. Trial registration numbers NCT03917914; CTRI/2020/08/027322.
AB - Introduction Heart disease in chronic obstructive pulmonary disease (COPD) is a common but neglected comorbidity. Patients with COPD are frequently excluded from clinical trials of treatments aimed at reducing cardiac morbidity and mortality, which has led to undertreatment of cardiovascular disease in patients with COPD. A particular concern in COPD is the underuse of beta (β)-blockers. There is observational evidence that cardioselective β-blockers are safe and may even reduce mortality risk in COPD, although some evidence is conflicting. There is an urgent need to answer the research question: Are cardioselective β-blockers safe and of benefit in people with moderately severe COPD? The proposed study will investigate whether cardioselective β-blocker treatment in patients with COPD reduces mortality and cardiac and respiratory morbidity. Methods and analyses This is a double-blind, randomised controlled trial to be conducted in approximately 26 sites in Australia, New Zealand, India, Sri Lanka and other countries as required. Participants with COPD will be randomised to either bisoprolol once daily (range 1.25-5 mg, dependent on tolerated dose) or matched placebo, in addition to receiving usual care for their COPD over the study duration of 24 months. The study will enrol 1164 participants with moderate to severe COPD, aged 40-85 years. Participants will be symptomatic from their COPD and have a postbronchodilator forced expiratory volume in 1 s (FEV 1) ≥30% and ≤70% predicted and a history of at least one exacerbation requiring systemic corticosteroids, antibiotics or both in the prior 24 months. Ethics and dissemination The study protocol has been approved by the Sydney Local Health District Human Research Ethics Committee at The Concord Repatriation General Hospital. Trial registration numbers NCT03917914; CTRI/2020/08/027322.
KW - chronic airways disease
KW - heart failure
KW - myocardial infarction
KW - stroke
UR - http://www.scopus.com/inward/record.url?scp=85114366571&partnerID=8YFLogxK
UR - http://purl.org/au-research/grants/nhmrc/GNT1163143
U2 - 10.1136/bmjopen-2021-053446
DO - 10.1136/bmjopen-2021-053446
M3 - Article
C2 - 34452971
AN - SCOPUS:85114366571
SN - 2044-6055
VL - 11
SP - 1
EP - 9
JO - BMJ Open
JF - BMJ Open
IS - 8
M1 - e053446
ER -