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Published ahead of print on December 12, 2002, doi:10.1164/rccm.200208-855OC

Am. J. Respir. Crit. Care Med., Volume 167, Number 6, March 2003, 841-849

A more recent version of this article appeared on March 15, 2003
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Submitted on August 23, 2002
Accepted on November 19, 2002

Significant microbiologic effect of inhaled tobramycin in young children with cystic fibrosis

Ronald L Gibson1*, Julia Emerson1, Sharon McNamara1, Jane L Burns1, Margaret Rosenfeld1, Ann Yunker2, Nicole Hamblett2, Frank Accurso3, Mark Dovey1, Peter Hiatt4, Michael W Konstan5, Richard Moss6, George Retsch-Bogart7, Jeffrey Wagener3, and Bonnie Ramsey8

1 Pediatrics, Children's Hospital and Regional Medical Center/University of Washington, Seattle, WA, USA, 2 Cystic Fibrosis Foundation/University of Washington, Cystic Fibrosis Therapeutics Development Network, Seattle, WA, USA, 3 Pediatrics, University of Colorado, Denver, CO, USA, 4 Pediatrics, Baylor College of Medicine, Houston, TX, USA, 5 Pediatrics, Case Western Reserve University, Cleveland, OH, USA, 6 Pediatrics, Stanford University, Palo Alto, CA, USA, 7 Pediatrics, University of North Carolina, Chapel Hill, Chapel Hill, NC, USA, 8 Pediatrics, Children's Hospital and Regional Medical Center/University of Washington, Seattle, WA, USA; Cystic Fibrosis Foundation/University of Washington, Cystic Fibrosis Therapeutics Development Network, Seattle, WA, USA

* To whom correspondence should be addressed. E-mail: rgibso{at}chmc.org.

We conducted a double-blind, placebo-controlled, multicenter, randomized trial to test the hypothesis that 300 milligrams of tobramycin solution for inhalation administered twice daily for 28 days would be safe and result in a profound decrease in Pseudomonas aeruginosa density from the lower airway of young children with cystic fibrosis. Ninety-eight subjects were to be randomized, however the trial was stopped early due to evidence of a significant microbiologic treatment effect. Twenty-one children under age 6 were randomized (8 active; 13 placebo) and underwent bronchoalveolar lavage at baseline and Day 28. There was a significant difference between treatment groups in the reduction in P. aeruginosa density; no P. aeruginosa was detected at Day 28 in 8 of 8 active group patients compared to 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. We conclude that 28 days of tobramycin solution for inhalation 300 milligrams twice daily is safe and effective for significant reduction of lower airway P. aeruginosa density in young children with cystic fibrosis.
Key words: lung, Pseudomonas, bronchoalveolar lavage




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