ROSCO-CF is an exploratory, phase 2a, randomized, double-blind, placebo-controlled, parallel-group study conducted to assess the safety and efficacy of oral R-roscovitine in chronic Pseudomonas aeruginosa (PA) lung infections in patients with cystic fibrosis (pwCF).

The study design of the ROSCO-CF study has been previously described in [5a] . Shortly, the ROSCO-CF study (NCT 01944735) was a safety validation, multicenter, double-blind, placebo-controlled, dose-ranging study, phase IIa clinical trial conducted in France on 34 CF patients chronically infected with PA and with at least one F508del-CFTR mutation. The experimental time-course was as follows: a 4-week treatment period and a 4-week follow-up period. Three doses of R-roscovitine were administered orally (200, 400, 800 mg). Forty sputum samples from 20 patients and 32 stool samples from 16 patients were recovered at two time-points: (1) before the first intake of the drug (-J14 to J0) (2) after treatment initiation (J15 to J28).