A randomised clinical trial of nebulised tobramycin or colistin in cystic fibrosis

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Abstract
Chronic infection withPseudomonas aeruginosais associated with progressive deterioration in lung function in cystic fibrosis (CF) patients. The purpose of this trial was to assess the efficacy and safety of tobramycin nebuliser solution (TNS) and nebulised colistin in CF patients chronically infected withP. aeruginosa.One-hundred and fifteen patients, aged ≥6 yrs, were randomised to receive either TNS or colistin, twice daily for 4 weeks. The primary end point was an evaluation of the relative change in lung function from baseline, as measured by forced expiratory volume in one second % predicted. Secondary end points included changes in sputumP. aeruginosadensity, tobramycin/colistin minimum inhibitory concentrations and safety assessments.TNS produced a mean 6.7% improvement in lung function (p=0.006), whilst there was no significant improvement in the colistin-treated patients (mean change 0.37%). Both nebulised antibiotic regimens produced a significant decrease in the sputumP. aeruginosadensity, and there was no development of highly resistant strains over the course of the study. The safety profile for both nebulised antibiotics was good.Tobramycin nebuliser solution significantly improved lung function of patients with cystic fibrosis chronically infected withPseudomonas aeruginosa, but colistin did not, in this study of 1-month's duration. Both treatments reduced the bacterial load.