RCT: Safety and efficacy of colistimethate sodium dry powder for inhalation (Colobreathe DPI) in patients with cystic fibrosis

Source: Thorax Area: News According to a study published early online in Thorax, colistimethate sodium dry powder for inhalation (Colobreathe DPI) CDPI has demonstrated efficacy by virtue of non-inferiority to tobramycin inhaler solution, in lung function after 24 weeks of treatment in cystic fibrosis (CF) patients.   The phase III prospective, randomised open-label study involved 380 patients with stable CF aged ?6 years with chronic P aeruginosa lung infection. Patients were randomised to Colobreathe dry powder for inhalation (CDPI, one capsule containing colistimethate sodium 1 662 500 IU, twice daily, n=187) or three 28-day cycles with twice-daily 300 mg/5 mL tobramycin inhaler solution (TIS, n=193). The following results were reported:   . The mean changes in FEV1 percentage predicted from baseline to week 24 were 0.964 for CDPI and 0.986 for TSI (adjusted treatment comparison ?0.97, 95% CI ?2.74 to 0.86). . The lower limit of the 95% CI (?2.71%, for patients who ...
Source: NeLM - News - Category: Drugs & Pharmacology Source Type: news