STABILISE

STABILISE: A multicentre, randomised, parallel group, superiority trial to inveSTigAte the use of BCG vaccine In aLtering Immune reSponse and Exacerbation in chronic obstructive pulmonary disease (COPD)

Updated 16 July 2025

STABILISE trial is a multicentre,two arm,parallel group,superiority,randomised controlled trial,with an internal pilot,a process evaluation,an acceptability study and embedded mechanistic work. The primary objective of the trial is to determine whether the Bacillus Calmette–Guérin (BCG) vaccination reduces rates of moderate-severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD) at 12 months in patients who have a clinical diagnosis of COPD,and a history of exacerbations in the preceding year. The secondary clinical objectives are to compare the rate of hospitalisations for infective exacerbations,QOL,total number of days of antibiotic and steroid therapy use during the follow up period between intervention and control groups and to determine the acceptability of the BCG vaccine. The intervention arm will receive a single dose of BCG vaccine while the control arm will receive no vaccine. We will be recruiting adults patients aged 18 or over who have a primary clinical diagnosis of COPD and have had ≥2 exacerbations in the last 12 months. 804 (402 in each arm) participants are required.