TY - JOUR
T1 - Dual bronchodilators in Bronchiectasis study (DIBS)
T2 - protocol for a pragmatic, multicentre, placebo-controlled, three-arm, double-blinded, randomised controlled trial studying bronchodilators in preventing exacerbations of bronchiectasis
AU - Morton, Miranda
AU - Wilson, Nina
AU - Homer, Tara Marie
AU - Simms, Laura
AU - Steel, Alison
AU - Maier, Rebecca
AU - Wason, James
AU - Ternent, Laura
AU - Abouhajar, Alaa
AU - Allen, Maria
AU - Joyce, Richard
AU - Hildreth, Victoria
AU - Lakey, Rachel
AU - Cherlin, Svetlana
AU - Walker, Adam
AU - Devereux, Graham
AU - Chalmers, James D.
AU - Hill, Adam T.
AU - Haworth, Charles
AU - Hurst, John R.
AU - De Soyza, Anthony
N1 - Funding Information:
National Institute for Health Research (NIHR) Health Technology Assessment (HTA), funder reference NIHR127460. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.
Copyright:
© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.
PY - 2023/8/10
Y1 - 2023/8/10
N2 - 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.
AB - 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.
KW - Adult
KW - Humans
KW - Bronchodilator Agents/therapeutic use
KW - Quality of Life
KW - Adrenergic beta-2 Receptor Agonists
KW - Muscarinic Antagonists
KW - Bronchiectasis/drug therapy
KW - Pulmonary Disease, Chronic Obstructive/drug therapy
KW - Administration, Inhalation
KW - Drug Therapy, Combination
KW - Adrenal Cortex Hormones/therapeutic use
KW - Anti-Bacterial Agents/therapeutic use
KW - Randomized Controlled Trials as Topic
KW - Multicenter Studies as Topic
KW - Adult thoracic medicine
KW - Clinical trials
KW - RESPIRATORY MEDICINE (see Thoracic Medicine)
U2 - 10.1136/bmjopen-2023-071906
DO - 10.1136/bmjopen-2023-071906
M3 - Article
C2 - 37562935
SN - 2044-6055
VL - 13
SP - e071906
JO - BMJ Open
JF - BMJ Open
IS - 8
M1 - e071906
ER -