Dual Bronchodilators in Bronchiectasis Study (DIBS)

  • Research type

    Research Study

  • Full 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 bronchiectasis

  • IRAS ID

    275595

  • Contact name

    Anthony De Soyza

  • Contact email

    anthony.de-soyza@newcastle.ac.uk

  • Sponsor organisation

    Newcastle upon Tyne Hospitals NHS Foundation Trust

  • Eudract number

    2019-004466-17

  • ISRCTN Number

    ISRCTN15988757

  • Duration of Study in the UK

    3 years, 1 months, 31 days

  • Research summary

    Bronchiectasis is a long-term lung condition which is unrelated to smoking, characterised by chronic phlegm production and repeated chest infections. In the UK, over 300,000 patients suffer from bronchiectasis with the majority suffering from chronic lung infections. Bronchiectasis research and treatment has been largely neglected despite the rising incidence of the condition. Bronchiectasis considerably impacts quality of life, causing over 4000 hospital admissions per year and reduces life expectancy.

    No treatments have been agreed for bronchiectasis, therefore treatment used for other lung conditions such as asthma and chronic obstructive pulmonary disease (COPD) are used resulting in a big difference in care. Current treatment is aimed at preventing further damage to the airways, improving mucus clearance, easing airflow limitation and reducing infective exacerbations. Standard care is currently chest physiotherapy and antibiotics for acute infections.

    In this trial we aim to test two hypotheses:
    1. Dual therapy bronchodilators as standalone therapy or in combination with Inhaled corticosteroid (triple therapy) can reduce exacerbation rates over 12 months.
    2. Dual therapy bronchodilators are no different to triple therapy bronchodilators in reducing exacerbation rates over 12 months.

    The primary outcome is number of exacerbations requiring antibiotic treatment over a 12 month period. The primary economic outcome is the cost-per-QALY at 12 months.
    We will recruit 600 participants in total from primary and secondary care from across the UK (50 participants recruited across 10 trial sites as part of a 6 month internal pilot and 550 participants recruited across 25 trial sites as part of the main trial). Participants will be randomised to triple or dual therapy or placebo inhaler for 12 months. Participants will be followed up at one, six and 12 months, to collect primary outcome data and data on adverse events, healthcare utilisation, quality of life, breathlessness and lung function.

  • REC name

    North East - Newcastle & North Tyneside 2 Research Ethics Committee

  • REC reference

    21/NE/0020

  • Date of REC Opinion

    29 Jan 2021

  • REC opinion

    Favourable Opinion