Baseline characteristics of an RCT using a bronchiectasis management plan

Abstract

Introduction/Aims: Management of acute respiratory exacerbations of bronchiectasis is a high patient-identified priority, yet management strategies remain limited. Personalised management plans for exacerbations have been shown to improve clinical outcomes in respiratory conditions (e.g., asthma). However, while recommended in bronchiectasis, there is currently an absence of evidence for their efficacy. Thus, we aimed to determine whether the routine use of a personalised bronchiectasis action management plan (BAMP) (compared to standard care) reduces non-scheduled doctor visits. Methods: We conducted a multi-centre, double-blind randomised controlled trial (RCT) based in Darwin, Brisbane and Perth. Our primary outcome was the rate of non-scheduled doctor visits for respiratory exacerbations by 12-months. Secondary outcomes include cough-specific quality-of-life (QoL) scores at 6- and 12-months, overall exacerbation rate over 12-months and the proportion of children who received timely influenza vaccination annually. Children/adolescents aged <19-years with chronic suppurative lung disease or radiologically confirmed bronchiectasis with ≥2 exacerbations in the previous 18-months were randomised to receive a personalised BAMP or standard care. Caregivers were followed up monthly for 12-months. Here we report baseline characteristics of the overall cohort. Results: Between June 2018 and December 2020, 591 children were screened and 207 randomised. The median age at enrolment was 5.6 years (interquartile range 3.4-8.1), 54.9% (n = 113) were males and 13% (n = 27) identified as First Nations. Post-infectious was the most common aetiology for bronchiectasis (n = 128, 61.8%). Six participants withdrew (2.9%), 9 (3.4%) were loss to follow-up, and 192 (92.7%) completed 12-months follow-up. An a-priori analyses is currently being undertaken. Conclusion: This study addresses a major research gap; if effective will provide high-level evidence that could lead to change in routine clinical practice and better management for children/adolescents with bronchiectasis.