The LEAP-Cough study is a multicentre cohort study with an embedded randomised controlled trial (RCT). The RCT is investigating if 9 months of azithromycin reduces recurrent protracted bacterial bronchitis (PBB) and bronchiectasis risk at 12 and 24 months in high risk children. Children who require recurrent antibiotics for chronic wet cough, have lower airway Haemophilis influenzae infection or greater than 3 episodes of PBB a year are at a higher risk of bronchiectasis, yet there are no therapies to prevent bronchiectasis.

LEAP-Cough is being carried out across five Australian states, Queensland, Western Australia, Northern Territory, New South Wales and Victoria. The study is funded by the Medical Research Future Fund (MRFF) and is supported by our Parent Advisory group and our Darwin-based First Nations Reference Group. The study aims to enrol 274 children in the RCT, where half will receive azithromycin. We will also investigate if azithromycin improves clinical outcomes and is cost-effective.

The LEAP-Cough cohort will also aims to identify new pheno- and endo-types in children with chronic wet cough, leading to the discovery of novel biomarkers and/or predictors of poorer outcomes. The results from this study will potentially prevent the development of recurrent episodes of PBB and bronchiectasis in children who have chronic wet cough, and will provide evidence to improve clinical management.