1. Dual bronchodilators in Bronchiectasis study (DIBS): protocol for a pragmatic, multicentre, placebo-controlled, three-arm, double-blinded, randomised controlled trial studying bronchodilators in preventing exacerbations of bronchiectasis.
- Author
-
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, and De Soyza A
- Subjects
- Adult, Humans, Bronchodilator Agents therapeutic use, Quality of Life, Adrenergic beta-2 Receptor Agonists, Muscarinic Antagonists, Administration, Inhalation, Drug Therapy, Combination, Adrenal Cortex Hormones therapeutic use, Anti-Bacterial Agents therapeutic use, Randomized Controlled Trials as Topic, Multicenter Studies as Topic, Bronchiectasis drug therapy, Pulmonary Disease, Chronic Obstructive drug therapy
- Abstract
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)., Trial Registration Number: ISRCTN15988757., Competing Interests: Competing interests: ADS has received speakers fees or advisory board fees from AstraZeneca, Bayer, GSK, Insmed, Novartis, Gilead and Zambon and has received grants from AstraZeneca, GSK, Novartis and the US COPD Foundation., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)
- Published
- 2023
- Full Text
- View/download PDF