Newcastle Clinical Trials Unit



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