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

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.
AuthorsRonald 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,
JournalAmerican journal of respiratory and critical care medicine (Am J Respir Crit Care Med) Vol. 167 Issue 6 Pg. 841-9 (Mar 15 2003) ISSN: 1073-449X [Print] United States
PMID12480612 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)
Chemical References
  • Anti-Bacterial Agents
  • Creatinine
  • Tobramycin
  • Administration, Inhalation
  • Age Factors
  • Anti-Bacterial Agents (administration & dosage, blood, pharmacology)
  • Audiometry
  • Bronchoalveolar Lavage Fluid (microbiology)
  • Carrier State (diagnosis, drug therapy)
  • Child, Preschool
  • Creatinine (blood)
  • Cystic Fibrosis (blood, complications, genetics)
  • Double-Blind Method
  • Drug Administration Schedule
  • Drug Monitoring
  • Female
  • Genotype
  • Hearing Disorders (chemically induced, diagnosis)
  • Humans
  • Kidney Diseases (chemically induced, diagnosis)
  • Male
  • Oropharynx (microbiology)
  • Pseudomonas Infections (diagnosis, drug therapy, etiology)
  • Pseudomonas aeruginosa
  • Respiratory Tract Infections (diagnosis, drug therapy, etiology)
  • Safety
  • Severity of Illness Index
  • Sputum (microbiology)
  • Tobramycin (administration & dosage, blood, pharmacology)
  • Treatment Outcome

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