{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,8]],"date-time":"2026-09-08T09:09:18Z","timestamp":1788858558304,"version":"build-2803163510"},"reference-count":44,"publisher":"National Institute for Health and Care Research","license":[{"start":{"date-parts":[[2026,2,1]],"date-time":"2026-02-01T00:00:00Z","timestamp":1769904000000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment programme","doi-asserted-by":"publisher","award":["NIHR127460"],"award-info":[{"award-number":["NIHR127460"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journalslibrary.nihr.ac.uk"],"crossmark-restriction":false},"short-container-title":["Health Technol Assess"],"abstract":"\n Background<\/jats:title>\n Bronchiectasis is a long-term lung condition associated with bronchial dilatation, chronic inflammation and infection. Treatment is often empirical or extrapolated from other lung conditions, for example the use of inhaled therapies licensed for use in asthma or chronic obstructive pulmonary disease. Inhaled therapies, such as corticosteroids or long-acting bronchodilators (long-acting beta agonists or long-acting muscarinic antagonists), are commonly used in bronchiectasis despite scanty evidence on exacerbation reduction.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To assess whether:<\/jats:p>\n \n \n dual bronchodilators (long-acting beta agonists\/long-acting muscarinic antagonists) either as stand-alone therapy or in combination with inhaled corticosteroid are superior to placebo at reducing mean exacerbation rates over 12 months<\/jats:p>\n <\/jats:list-item>\n \n dual bronchodilators (long-acting beta agonists\/long-acting muscarinic antagonists) are non-inferior to triple therapy (inhaled corticosteroid\/long-acting beta agonists\/long-acting muscarinic antagonists) at reducing mean exacerbation rates over 12 months.<\/jats:p>\n <\/jats:list-item>\n <\/jats:list>\n <\/jats:sec>\n \n Design<\/jats:title>\n Pragmatic, multicentre, placebo-controlled, three-arm, double-blinded, prospective, randomised controlled trial incorporating a 12-month internal pilot.<\/jats:p>\n <\/jats:sec>\n \n Target population<\/jats:title>\n Six hundred adults with bronchiectasis and history of \u2265\u20052 exacerbations in any 12-month period within the preceding 2 years.<\/jats:p>\n <\/jats:sec>\n \n Setting<\/jats:title>\n United Kingdom National Health Service secondary care sites.<\/jats:p>\n <\/jats:sec>\n \n Interventions<\/jats:title>\n Twelve months, one puff daily of either dual therapy [55 \u03bcg umeclidinium (long-acting muscarinic antagonists) and 22 \u03bcg vilanterol (long-acting beta agonists)], triple therapy [dual therapy plus 92 \u03bcg fluticasone furoate (inhaled corticosteroid)] or matched placebo dry powder inhalers, randomised in a 2\u2005:\u20052\u2005:\u20051 ratio, respectively.<\/jats:p>\n <\/jats:sec>\n \n Outcome measures<\/jats:title>\n Primary: number of participants reported bronchiectasis exacerbations requiring treatment with antibiotics during the 12-month treatment period.<\/jats:p>\n Primary economic: incremental cost per quality-adjusted life-year gained at 12 months.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n Recruitment rates did not follow projections due to the COVID-19 pandemic; 85 potentially eligible patients were screened, of whom 33 (39%) were randomised. Of the randomised participants, 30 (91%) completed follow-up at 12 months; 3 participants withdrew [1\/14 (7%) dual therapy, 1\/12 (8%) triple therapy and 1\/7 (14%) placebo]. Five participants discontinued therapy during the trial [1\/14 (7%) dual therapy, 2\/12 (17%) triple therapy and 2\/7 (29%) placebo].<\/jats:p>\n Given the small sample size, the statistical and economic analyses are descriptive and exploratory. Exacerbation data were available for 32\/33 (97%) of randomised participants (13 dual therapy, 12 triple therapy and 7 placebo). The median number of exacerbations during the follow-up (the primary outcome) was 1 (interquartile range 0\u20133) for dual therapy, 2 (1, 2.5) for triple therapy and 3 (2, 3) for placebo. No safety concerns were identified. Complete resource-use and quality-of-life data were available for 30\/33 (91%) participants.<\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n COVID-19 impacted delivery of the trial, affecting staff capacity, setting up of timelines, and ultimately, recruitment to the pilot. There was good retention and data completeness within the trial randomised participants. The trial is unable to provide evidence on the superiority or cost-effectiveness of dual or triple therapy to placebo at reducing mean exacerbation rates over 12 months or the non-inferiority of dual to triple therapy.<\/jats:p>\n <\/jats:sec>\n \n Future work and limitations<\/jats:title>\n The main limitation of this work is the small sample size that prevents any firm conclusions to be made. However, the results do suggest that there is a signal of efficacy and that a larger trial is needed to provide valuable clinical evidence. These results underscore the importance of completing a large-scale trial of these therapies to help improve the understanding and best treatment for patients with bronchiectasis.<\/jats:p>\n <\/jats:sec>\n \n Funding<\/jats:title>\n This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number NIHR127460.<\/jats:p>\n <\/jats:sec>","DOI":"10.3310\/ggcc1111","type":"journal-article","created":{"date-parts":[[2025,2,11]],"date-time":"2025-02-11T05:28:46Z","timestamp":1739251726000},"page":"1-77","update-policy":"https:\/\/doi.org\/10.3310\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["A pragmatic, multicentre, placebo-controlled, 3-arm, double-blinded, randomised controlled trial, incorporating an internal pilot, to determine the role of bronchodilators in preventing exacerbations of 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