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Copyright ©ERS Journals Ltd 2002
A randomised clinical trial of nebulised tobramycin or colistin in cystic fibrosis
1 Royal Brompton & Harefield NHS Trust, London, UK. 2 St Vincent's University Hospital, Dublin, Ireland. 3 Medical School, University of Edinburgh, Edinburgh, UK
CORRESPONDENCE: M.E. Hodson, Dept of Cystic Fibrosis, Royal Brompton & Harefield NHS Trust, Sydney Street, London, SW3 6NP, UK. Fax: 44 2073518052. E-mail: s.hockley@ic.ac.uk
Keywords: colistin, cystic fibrosis, Pseudomonas aeruginosa, tobramycin
Received: May 29, 2001
Accepted March 20, 2002
This study was sponsored by PathoGenesis Ltd, Hownslow, UK.
Chronic infection with Pseudomonas aeruginosa is 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 with P. aeruginosa.
One-hundred and fifteen patients, aged
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 sputum P. aeruginosa density, 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 with Pseudomonas aeruginosa, but colistin did not, in this study of 1-month's duration. Both treatments reduced the bacterial load.
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 sputum P. aeruginosa density, tobramycin/colistin minimum inhibitory concentrations and safety assessments.
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