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

Ronald L. Gibson, Julia Emerson, Sharon McNamara, Jane L. Burns, Margaret Rosenfeld, Ann Yunker, Nicole Hamblett, Frank Accurso, Mark Dovey, Peter Hiatt, Michael W. Konstan, Richard Moss, George Retsch-Bogart, Jeffrey Wagener, David Waltz, Robert Wilmott, Pamela L. Zeitlin, Bonnie Ramsey, Morty Cohen, Jessica FosterCharlene Hallmark, Trish Hasbrouck, Jay Hilliard, Kate Hilliard, Lori Ingham, Craig Johnson, Vikki Kociela, Richard Kronmal, Sally Locke, Jean Mundahl, Iris Osberg, Churee Penvari, Jenny Stapp, Sharon Watts, Marcia Wertz, Judy Williams

Research output: Contribution to journalArticlepeer-review

Abstract

We conducted a double-blind, placebo-controlled, multicenter, randomized trial to test the hypothesis that 300 mg of tobramycin solution for inhalation administered twice daily for 28 days would be safe and result in a profound decrease in Pseudomonas aeruginosa (Pa) density from the lower airway of young children with cystic fibrosis. Ninety-eight subjects were to be randomized; however, the trial was stopped early because of evidence of a significant microbiological treatment effect. Twenty-one children under age 6 years were randomized (8 active; 13 placebo) and underwent bronchoalveolar lavage at baseline and on Day 28. 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. We conclude that 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.

Original languageEnglish (US)
Pages (from-to)841-849
Number of pages9
JournalAmerican journal of respiratory and critical care medicine
Volume167
Issue number6
DOIs
StatePublished - Mar 15 2003

Keywords

  • Bronchoalveolar lavage
  • Lung
  • Pseudomonas

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine
  • Critical Care and Intensive Care Medicine

Fingerprint Dive into the research topics of 'Significant microbiological effect of inhaled tobramycin in young children with cystic fibrosis'. Together they form a unique fingerprint.

Cite this