Study design (if review, criteria of inclusion for studies)
systematic review
List of included studies
Chronic Pseudomonas aeruginosa in cystic fibrosis
Participants
Cystic fibrosis patients with chronic Pseudomonas aeruginosa
Interventions
Two dry powder formulations, colistimethate sodium and tobramycin
Outcome measures
Relevant outcomes included rate and extent of microbial response (e.g. sputum density of P. aeruginosa), lung function (e.g. forced expiratory volume in 1 s (FEV1)), frequency, severity of acute exacerbations and adverse events.
Main results
Three trials were included, and both dry powder formulations were reported to be non-inferior in the short term to nebulised tobramycin for FEV1. However, long-term follow-up data were missing and the effect on exacerbation rates was not always reported. Whilst short-term results showed that both dry powder drugs were non-inferior to nebulised tobramycin, there was no long-term follow-up and no phase 3 trials compared nebulised and dry powder colistimethate sodium. The use of FEV1 as the primary end-point may not accurately represent changes in lung health.
Authors' conclusions
This review illustrates the difficulty in assessing new technologies where the evidence base is poor.