Preventing adverse cardiac events (PACE) in chronic obstructive pulmonary disease (COPD): study protocol for a double-blind, placebo controlled, randomised controlled trial of bisoprolol in COPD
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...
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BMJ Publishing Group
2021-08-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/11/8/e053446.full |
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| author | Graham S Hillis Richard Beasley Claudia C Dobler Christine Jenkins Ian A Yang Jeremy Wrobel Allison Martin Robert J Hancox Belinda Cochrane Catherina L Chang Vanessa McDonald Claude S Farah Caroline Polak Scowcroft Ashutosh Aggarwal Grace Balicki Shane Galgey |
| author_facet | Graham S Hillis Richard Beasley Claudia C Dobler Christine Jenkins Ian A Yang Jeremy Wrobel Allison Martin Robert J Hancox Belinda Cochrane Catherina L Chang Vanessa McDonald Claude S Farah Caroline Polak Scowcroft Ashutosh Aggarwal Grace Balicki Shane Galgey |
| author_sort | Graham S Hillis |
| collection | DOAJ |
| description | 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 (FEV1) ≥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. |
| format | Article |
| id | doaj-art-eb2dc2361cde4425af2f628e5759b3d3 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2021-08-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-eb2dc2361cde4425af2f628e5759b3d32024-12-08T17:15:09ZengBMJ Publishing GroupBMJ Open2044-60552021-08-0111810.1136/bmjopen-2021-053446Preventing adverse cardiac events (PACE) in chronic obstructive pulmonary disease (COPD): study protocol for a double-blind, placebo controlled, randomised controlled trial of bisoprolol in COPDGraham S Hillis0Richard Beasley1Claudia C Dobler2Christine Jenkins3Ian A Yang4Jeremy Wrobel5Allison Martin6Robert J Hancox7Belinda Cochrane8Catherina L Chang9Vanessa McDonald10Claude S Farah11Caroline Polak Scowcroft12Ashutosh Aggarwal13Grace Balicki14Shane Galgey159 Cardiology, Royal Perth Hospital, Perth, Western Australia, Australia2 Victoria University Wellington, Wellington, New ZealandLiverpool Hospital, Liverpool, New South Wales, AustraliaThe George Institute for Global Health, Newtown, New South Wales, AustraliaThe Prince Charles Hospital, Chermside, Queensland, Australia9 Department of Respiratory Medicine, Fiona Stanley Hospital, Murdoch, Western Australia, AustraliaUniversity of New South Wales, Sydney, New South Wales, Australia1 Department of Preventive & Social Medicine, University of Otago, Dunedin, New ZealandWestern Sydney University, Penrith, NSW, AustraliaDepartment of Respiratory Medicine and Respiratory research unit, Waikato Hospital, Hamilton, New ZealandUniversity of Newcastle, Callaghan, New South Wales, AustraliaConcord Repatriation General Hospital, Concord, New South Wales, AustraliaConsumer Representative, Canberra, ACT, AustraliaPost Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, IndiaThe George Institute for Global Health, Newtown, New South Wales, AustraliaThe George Institute for Global Health, Newtown, New South Wales, AustraliaIntroduction 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 (FEV1) ≥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.https://bmjopen.bmj.com/content/11/8/e053446.full |
| spellingShingle | Graham S Hillis Richard Beasley Claudia C Dobler Christine Jenkins Ian A Yang Jeremy Wrobel Allison Martin Robert J Hancox Belinda Cochrane Catherina L Chang Vanessa McDonald Claude S Farah Caroline Polak Scowcroft Ashutosh Aggarwal Grace Balicki Shane Galgey Preventing adverse cardiac events (PACE) in chronic obstructive pulmonary disease (COPD): study protocol for a double-blind, placebo controlled, randomised controlled trial of bisoprolol in COPD BMJ Open |
| title | Preventing adverse cardiac events (PACE) in chronic obstructive pulmonary disease (COPD): study protocol for a double-blind, placebo controlled, randomised controlled trial of bisoprolol in COPD |
| title_full | Preventing adverse cardiac events (PACE) in chronic obstructive pulmonary disease (COPD): study protocol for a double-blind, placebo controlled, randomised controlled trial of bisoprolol in COPD |
| title_fullStr | Preventing adverse cardiac events (PACE) in chronic obstructive pulmonary disease (COPD): study protocol for a double-blind, placebo controlled, randomised controlled trial of bisoprolol in COPD |
| title_full_unstemmed | Preventing adverse cardiac events (PACE) in chronic obstructive pulmonary disease (COPD): study protocol for a double-blind, placebo controlled, randomised controlled trial of bisoprolol in COPD |
| title_short | Preventing adverse cardiac events (PACE) in chronic obstructive pulmonary disease (COPD): study protocol for a double-blind, placebo controlled, randomised controlled trial of bisoprolol in COPD |
| title_sort | preventing adverse cardiac events pace in chronic obstructive pulmonary disease copd study protocol for a double blind placebo controlled randomised controlled trial of bisoprolol in copd |
| url | https://bmjopen.bmj.com/content/11/8/e053446.full |
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