Positive P. aeruginosa culture. 21 participants (11 males) age range 6 months - 6 years.
Interventions
Tobramycin 300 mg or placebo twice daily for 28 days.
Outcome measures
Density of P. aeruginosa on BAL culture. Adverse effects. Weight.
Main results
There was a significant difference between treatment groups in the reduction in Pa density; no Pa was detected on Day 28 in 8 of 8 active group patients compared with 1 of 13 placebo group patients. We observed no differences between treatment groups for clinical indices, markers of inflammation, or incidence of adverse events. No abnormalities in serum creatinine or audiometry and no episodes of significant bronchospasm were observed in association with active treatment.
Authors' conclusions
28 days of tobramycin solution for inhalation of 300 mg twice daily is safe and effective for significant reduction of lower airway Pa density in young children with cystic fibrosis.