Study design (if review, criteria of inclusion for studies)
randomised cross over study.
Participants
10 CF-patients, chronically infected with P. aeruginosa
Interventions
On two visits to the outpatient clinic, patients inhaled colistin sulphomethate as 25 mg dry powder (Twincer) or as 158 mg nebulised solution (Ventstream nebuliser, PortaNeb compressor).
Outcome measures
Pulmonary function tests were performed before, 5 and 30 min after inhalation. Serum samples were drawn prior to each dose and at 15, 45 min, 1.5; 2.5; 3.5 and 5.5 h after inhalation.
Main results
The DPI was well tolerated by the patients: no significant reduction in FEV1 was observed. Relative bioavailability of DPI to nebulisation was approx. 140% based on actual dose and approx. 270% based on drug dose label claim.
Authors' conclusions
The colistin DPI (Twincer inhaler) is well tolerated and appreciated by CF-patients. Optimisation with respect to particle size and internal resistance of the inhaler is necessary to attain equivalent pulmonary deposition to liquid nebulisation.
Keywords: Adult; Anti-Bacterial Agents; Colistin; Inhalation OR nebulised; nebuliser; non pharmacological intervention - devices OR physiotherapy; pharmacological_intervention; Powders; Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Infection; other anti-bacterial agents;