Adults with CF and two well-characterized genetic mutations in the CFTR gene, persistent airways PA infection
Interventions
Colistimethate Sodium (CMS) 4 MIU: vials of CMS 4 MIU (320 mg CMS) are reconstituted with 8 mL 0,9% saline solution, once daily, administered by inhalation via a nebuliser for 28 days
Outcome measures
Primary outcomes: number of observed safety events during the 28-day treatment period in each treatment arm[The tolerability and safety will be assessed based on all reported adverse events (ie dyspnoea, bronchoconstriction, cough, wheezing) , clinical laboratory test results, vital signs measurements, electrocardiogram findings, physical examination findings and spirometry results, or clinically significant changes thereof.