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Lookup NU author(s): Dr Miranda PattersonORCiD, Dr Nina WilsonORCiD, Tara HomerORCiD, Laura Simms, Dr Alison SteelORCiD, Rebecca Maier, Professor James WasonORCiD, Professor Laura Ternent, Dr Alaa AbouhajarORCiD, Richard Joyce, Dr Victoria Hildreth, Dr Rachel Lakey, Dr Svetlana CherlinORCiD, Adam Walker, Professor Anthony De SoyzaORCiD
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
Introduction Bronchiectasis is a long-term lung condition, with dilated bronchi, chronic inflammation, chronic infection and acute exacerbations. Recurrent exacerbations are associated with poorer clinical outcomes such as increased severity of lung disease, further exacerbations, hospitalisations, reduced quality of life and increased risk of death. Despite an increasing prevalence of bronchiectasis, there is a critical lack of high-quality studies into the disease and no treatments specifically approved for its treatment. This trial aims to establish whether inhaled dual bronchodilators (long acting beta agonist (LABA) and long acting muscarinic antagonist (LAMA)) taken as either a stand-alone therapy or in combination with inhaled corticosteroid (ICS) reduce the number of exacerbations of bronchiectasis requiring treatment with antibiotics during a 12 month treatment period.Methods This is a multicentre, pragmatic, double-blind, randomised controlled trial, incorporating an internal pilot and embedded economic evaluation. 600 adult patients (≥18 years) with CT confirmed bronchiectasis will be recruited and randomised to either inhaled dual therapy (LABA+LAMA), triple therapy (LABA+LAMA+ICS) or matched placebo, in a 2:2:1 ratio (respectively). The primary outcome is the number of protocol defined exacerbations requiring treatment with antibiotics during the 12 month treatment period.Ethics and dissemination Favourable ethical opinion was received from the North East—Newcastle and North Tyneside 2 Research Ethics Committee (reference: 21/NE/0020). Results will be disseminated in peer-reviewed publications, at national and international conferences, in the NIHR Health Technology Assessments journal and to participants and the public (using lay language).
Author(s): Morton M, Wilson N, Homer TM, Simms L, Steel A, Maier R, Wason J, Ternent L, Abouhajar A, Allen M, Joyce R, Hildreth V, Lakey R, Cherlin S, Walker A, Devereux G, Chalmers JD, Hill AT, Haworth C, Hurst JR, De Soyza A
Publication type: Article
Publication status: Published
Journal: BMJ Open
Year: 2023
Volume: 13
Issue: 8
Online publication date: 10/08/2023
Acceptance date: 08/07/2023
Date deposited: 30/08/2023
ISSN (electronic): 2044-6055
Publisher: BMJ Group
URL: https://doi.org/10.1136/bmjopen-2023-071906
DOI: 10.1136/bmjopen-2023-071906
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