The study was registered (EudraCT2015-003881-96) and obtained a positive opinion from the Ethics Committee of Meyer Hospital and AIFA (18/5/2016). Patient randomization software and a service for centralising clinical and microbiological data were provided. To date, 36 patients, 18 males and 18 females (mean age 13.3 ± 10.4 years), were randomised in 3 centres. The mean ±SD FEV1 values at recruitment were 78.6 ± 20.8 (% of the predicted). 18 patients were randomised to classical treatment and 18 patients to classical treatment associated with nasal irrigations with colistin. 22 (61%) out of 36 patients completed 6 months of follow-up having performed 3 cultures. There are currently no differences in primary outcome. 14 (39%) patients, randomised most recently, have to complete the 6-month follow-up. The combination of classic eradication therapy together with nasal lavage might prove to be a simple and useful method for further delaying the reappearance of P. aeruginosa in the lungs of CF patients.

This study will be concluded in September 2018. The delay has been needed to manage administrative tasks with Ethical Committees and also feasible thanks to the agreed postponement exceptionally allowed by the Cystic Fibrosis Research Foundation.