Placebo-controlled, double-blind, randomized study of aerosolized tobramycin for early treatment of Pseudomonas aeruginosa colonization in cystic fibrosis.
Study design (if review, criteria of inclusion for studies)
prospective placebo-controlled, double-blind, randomized multicenter study
Participants
22 CF patients (13 male). Age > 4 years, mean 11.4 and 9.8 in 2 groups.
Interventions
Tobramycin 80 mg or placebo (saline with same preservatives) twice daily for 12 months shortly after the onset of P. aeruginosa pulmonary colonization
Outcome measures
Eradication of P. aeruginosa, lung function, inflammatory parameters.
Main results
2 patients in the tobramycin and 6 patients in the placebo group stopped inhalation before the 12 month treatment period. Using life table analysis, the time to conversion from a P. aeruginosa-positive to a P. aeruginosa-negative respiratory culture was significantly shorter in the tobramycin-treated group than in the placebo group (P < 0.05, log rank test). Lung function parameters and markers of inflammation did not change in either group during treatment.
Authors' conclusions
The results of this study suggest that early tobramycin inhalation may prevent and/or delay P. aeruginosa pulmonary infection in CF patients.