DIBS
DIBS
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
- Study stage: Recruiting
- Sponsor: The Newcastle upon Tyne Hospitals NHS Foundation Trust
- Funder: NIHR HTA
- Therapeutic area: Respiratory
- Type of study: CTIMP
Aim: To compare the effects of inhaled dual bronchodilators either as a stand-alone therapy (LABA/LAMA) or in combination with ICS (ICS/LABA/LAMA; triple therapy) therapy to placebo on the number of protocol defined bronchiectasis exacerbations (per participant)
Primary Outcome:
Number of protocol defined bronchiectasis exacerbations requiring treatment with antibiotics during 12 month treatment period as measured using participant reports/ participant completed weekly exacerbation diary.
- Population: Adult
- Phase: III
- Design: RCT and Health Economic
- Setting: Secondary care
- Planned Sample Size: 600