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A Comparison of Peak Sputum Tobramycin Concentration in Patients With Cystic Fibrosis Using Jet and Ultrasonic Nebulizer Systems

Jay Eisenberg; Margaret Pepe; Judy Williams-Warren; Michael Vasiliev; A. Bruce Montgomery; Arnold L. Smith; Bonnie W. Ramsey; Aerosolized Tobramycin Study Group
Author and Funding Information

Affiliations: From the Oregon Health Sciences University, Portland,  From the Department of Biostatistics, University of Washington, and Fred Hutchinson Cancer Research Center, Seattle,  From the Children's Hospital and Medical Center, Seattle,  From the PathoGenesis Corporation, Seattle,  From the Department of Microbiology and Immunology, University of Missouri, Columbia,  From the Department of Pediatrics, University of Washington School of Medicine, Seattle

Affiliations: From the Oregon Health Sciences University, Portland,  From the Department of Biostatistics, University of Washington, and Fred Hutchinson Cancer Research Center, Seattle,  From the Children's Hospital and Medical Center, Seattle,  From the PathoGenesis Corporation, Seattle,  From the Department of Microbiology and Immunology, University of Missouri, Columbia,  From the Department of Pediatrics, University of Washington School of Medicine, Seattle

Affiliations: From the Oregon Health Sciences University, Portland,  From the Department of Biostatistics, University of Washington, and Fred Hutchinson Cancer Research Center, Seattle,  From the Children's Hospital and Medical Center, Seattle,  From the PathoGenesis Corporation, Seattle,  From the Department of Microbiology and Immunology, University of Missouri, Columbia,  From the Department of Pediatrics, University of Washington School of Medicine, Seattle

Affiliations: From the Oregon Health Sciences University, Portland,  From the Department of Biostatistics, University of Washington, and Fred Hutchinson Cancer Research Center, Seattle,  From the Children's Hospital and Medical Center, Seattle,  From the PathoGenesis Corporation, Seattle,  From the Department of Microbiology and Immunology, University of Missouri, Columbia,  From the Department of Pediatrics, University of Washington School of Medicine, Seattle

Affiliations: From the Oregon Health Sciences University, Portland,  From the Department of Biostatistics, University of Washington, and Fred Hutchinson Cancer Research Center, Seattle,  From the Children's Hospital and Medical Center, Seattle,  From the PathoGenesis Corporation, Seattle,  From the Department of Microbiology and Immunology, University of Missouri, Columbia,  From the Department of Pediatrics, University of Washington School of Medicine, Seattle

Affiliations: From the Oregon Health Sciences University, Portland,  From the Department of Biostatistics, University of Washington, and Fred Hutchinson Cancer Research Center, Seattle,  From the Children's Hospital and Medical Center, Seattle,  From the PathoGenesis Corporation, Seattle,  From the Department of Microbiology and Immunology, University of Missouri, Columbia,  From the Department of Pediatrics, University of Washington School of Medicine, Seattle

Affiliations: From the Oregon Health Sciences University, Portland,  From the Department of Biostatistics, University of Washington, and Fred Hutchinson Cancer Research Center, Seattle,  From the Children's Hospital and Medical Center, Seattle,  From the PathoGenesis Corporation, Seattle,  From the Department of Microbiology and Immunology, University of Missouri, Columbia,  From the Department of Pediatrics, University of Washington School of Medicine, Seattle

Affiliations: From the Oregon Health Sciences University, Portland,  From the Department of Biostatistics, University of Washington, and Fred Hutchinson Cancer Research Center, Seattle,  From the Children's Hospital and Medical Center, Seattle,  From the PathoGenesis Corporation, Seattle,  From the Department of Microbiology and Immunology, University of Missouri, Columbia,  From the Department of Pediatrics, University of Washington School of Medicine, Seattle

Affiliations: From the Oregon Health Sciences University, Portland,  From the Department of Biostatistics, University of Washington, and Fred Hutchinson Cancer Research Center, Seattle,  From the Children's Hospital and Medical Center, Seattle,  From the PathoGenesis Corporation, Seattle,  From the Department of Microbiology and Immunology, University of Missouri, Columbia,  From the Department of Pediatrics, University of Washington School of Medicine, Seattle

Affiliations: From the Oregon Health Sciences University, Portland,  From the Department of Biostatistics, University of Washington, and Fred Hutchinson Cancer Research Center, Seattle,  From the Children's Hospital and Medical Center, Seattle,  From the PathoGenesis Corporation, Seattle,  From the Department of Microbiology and Immunology, University of Missouri, Columbia,  From the Department of Pediatrics, University of Washington School of Medicine, Seattle

Affiliations: From the Oregon Health Sciences University, Portland,  From the Department of Biostatistics, University of Washington, and Fred Hutchinson Cancer Research Center, Seattle,  From the Children's Hospital and Medical Center, Seattle,  From the PathoGenesis Corporation, Seattle,  From the Department of Microbiology and Immunology, University of Missouri, Columbia,  From the Department of Pediatrics, University of Washington School of Medicine, Seattle

Affiliations: From the Oregon Health Sciences University, Portland,  From the Department of Biostatistics, University of Washington, and Fred Hutchinson Cancer Research Center, Seattle,  From the Children's Hospital and Medical Center, Seattle,  From the PathoGenesis Corporation, Seattle,  From the Department of Microbiology and Immunology, University of Missouri, Columbia,  From the Department of Pediatrics, University of Washington School of Medicine, Seattle


Affiliations: From the Oregon Health Sciences University, Portland,  From the Department of Biostatistics, University of Washington, and Fred Hutchinson Cancer Research Center, Seattle,  From the Children's Hospital and Medical Center, Seattle,  From the PathoGenesis Corporation, Seattle,  From the Department of Microbiology and Immunology, University of Missouri, Columbia,  From the Department of Pediatrics, University of Washington School of Medicine, Seattle

1997 by the American College of Chest Physicians


Chest. 1997;111(4):955-962. doi:10.1378/chest.111.4.955
Text Size: A A A
Published online

Abstract

Study objective: To determine whether adequate concentrations of a new formulation of tobramycin could be delivered to the lower respiratory tract of patients with cystic fibrosis (CF) using a jet nebulizer delivery system.

Design: A multicenter, open-label, randomized, crossover study.

Setting: Ten tertiary care, university-affiliated, teaching hospitals in the United States.

Patients and control subjects: Sixty-eight patients recruited from 10 CF Foundation centers and who were at least 8 years of age, had a diagnosis of CF, and expectorated daily sputum. No control subjects enrolled.

Interventions: Each patient received one administration of aerosolized tobramycin from each of the three nebulizer systems in random order. Each administration was separated by a minimum of 48 h. The two jet nebulizer systems tested were the Sidestream (Medic-Aid; Sussex, UK), and the Pari LC (Pari Respiratory Equipment; Richmond, Va), with a DeVilbiss Pulmoaide compressor (DeVilbiss Health Care; Somerset, Pa), both administering 300 mg tobramycin in 5 mL of ¼ normal saline solution (NS). Patients were also administered 600 mg tobramycin in 30 mL of ½ NS with the UltraNeb 99/100 (DeVilbiss).

Measurements: Sputum and serum tobramycin concentration and pulmonary function were monitored. An adequate peak sputum tobramycin concentration was defined as >128 µg/g sputum at any of three time points (10, 60, or 120 min) after completion of treatments.

Results: The peak tobramycin concentrations in expectorated sputum were 687±663 µg/g (mean±SD) with the Pari LC and 489±402 µg/g with the Sidestream. Adequate peak sputum tobramycin concentration was achieved in 93% of the patients with the Sidestream, and in 87% of the patients with the Pari LC. Peak sputum concentrations were found to be substantially higher when patients received tobramycin administered with the UltraNeb 99/100, 1,498±1,331 µg/g with 30% of patients having levels exceeding 2,000 µg/g. Serum tobramycin concentrations were ≤4 µg/mL for all patients following administration with each nebulizer.

Conclusions: Adequately high sputum tobramycin concentrations were documented in sputum in >85% of patients following the administration of 300 mg/5 mL formulation of tobramycin aerosolized by the two jet nebulizer delivery systems, Sidestream and Pari LC. The single tobramycin administration delivered by these two systems is well-tolerated.


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