Dry powder inhalation of colistin in cystic fibrosis patients: a single dose pilot study

J Cyst Fibros. 2007 Jul;6(4):284-92. doi: 10.1016/j.jcf.2006.10.010. Epub 2006 Dec 20.

Abstract

Background: Dry powder inhalation (DPI) may be an alternative to nebulisation of drugs in the treatment of chest infections in cystic fibrosis (CF) patients. In a pilot study the feasibility of a colistin dry powder inhaler (prototype Twincer) by a single dose in CF-patients was assessed and compared to nebulised colistin.

Methods: Ten CF-patients, chronically infected with P. aeruginosa, participated in a randomised cross over study. 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). 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.

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.

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.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Administration, Inhalation
  • Adult
  • Anti-Bacterial Agents / administration & dosage*
  • Anti-Bacterial Agents / pharmacokinetics
  • Colistin / administration & dosage*
  • Colistin / pharmacokinetics
  • Cross-Over Studies
  • Cystic Fibrosis / drug therapy*
  • Cystic Fibrosis / metabolism
  • Cystic Fibrosis / physiopathology
  • Dose-Response Relationship, Drug
  • Feasibility Studies
  • Female
  • Follow-Up Studies
  • Forced Expiratory Flow Rates / drug effects
  • Forced Expiratory Volume / drug effects
  • Humans
  • Male
  • Middle Aged
  • Nebulizers and Vaporizers
  • Pilot Projects
  • Powders
  • Surveys and Questionnaires
  • Treatment Outcome

Substances

  • Anti-Bacterial Agents
  • Powders
  • Colistin