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Long-term Benefits of Inhaled Tobramycin in Adolescent Patients With Cystic Fibrosis^*

^* From the Department of Pediatrics, Stanford University Medical Center, Palo Alto, CA.

Correspondence to: Richard Moss, MD, FCCP, Stanford University Medical Center, 701 Welch Rd, #3328, Palo Alto, CA 94304-5786; e-mail: rmoss{at}stanford.edu

Study objective: To determine the effect of long-term suppression of Pseudomonas aeruginosa on lung function and other clinical end points in adolescent patients with cystic fibrosis (CF).

Design: Two identical, randomized, placebo-controlled trials followed by three open-label follow-on trials.

Setting: Sixty-nine CF study centers in the United States.

Interventions: Active drug consisting of a 300-mg tobramycin solution for inhalation (TSI).

Patients: One hundred twenty-eight adolescent CF patients (aged 13 to 17 years) with P aeruginosa and mild-to-moderate lung disease (FEV₁ percent predicted 25% and 75%).

Measurements: Pulmonary function, P aeruginosa colony forming unit density, incidence of hospitalization and IV antibiotic use, weight gain, and aminoglycoside toxicity were monitored.

Results: At the end of the first three 28-day cycles of TSI treatment, patients originally randomized to TSI and placebo treatments exhibited improvements in FEV₁ percent predicted of 13.5% and 9.4%, respectively. FEV₁ percent predicted was maintained above the value at initiation of TSI treatment in both groups. At the end of the last "on-drug" period (92 weeks), patients originally randomized to TSI and placebo treatments showed improvements of 14.3% and 1.8%, respectively. Improvement in pulmonary function was significantly correlated with reduction in P aeruginosa colony forming unit density (p = 0.0001). The average number of hospitalizations and IV antibiotic courses did not increase over time. TSI treatment was associated with increased weight gain and body mass index. P aeruginosa susceptibility to tobramycin decreased slightly over time, but this was not correlated with clinical response.

Conclusions: TSI treatment improved pulmonary function and weight gain in adolescent patients with CF over a 2-year period of long-term, intermittent use.

Key Words: aminoglycoside • cystic fibrosis • Pseudomonas aeruginosa • pulmonary function • tobramycin

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