A Study of the Safety and Efficacy of Tobramycin for Inhalation in Young Children With Cystic Fibrosis
NCT ID: NCT00006280
Last Updated: 2010-03-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
98 participants
INTERVENTIONAL
2000-02-29
2002-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
TREATMENT
DOUBLE
Interventions
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Tobramycin for Inhalation
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of cystic fibrosis with 2 clinical features consistent with CF and confirmed by either sweat chloride \>= 60 mEq/L (by quantitative pilocarpine iontophoresis) or by genotype with 2 identifiable mutations consistent with CF.
* One throat or sputum microbiology culture positive for Pseudomonas aeruginosa (Pa) within 2 weeks to 12 months prior to screening.
* Informed consent by parent or legal guardian.
Exclusion Criteria
* History of aminoglycoside hypersensitivity.
* History of unresolved anemia (hematocrit \< 30%) or thrombocytopenia (platelet count \< 100,000/mm3).
* History of hemoptysis with 30 days prior to screening.
* History of abnormal renal function (serum creatinine \> 1.5 times the upper limit of normal for age).
* History of clinically documented chronic hearing loss.
* Administration of any investigational drug within 30 days prior to screening.
6 Months
5 Years
ALL
No
Sponsors
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National Center for Research Resources (NCRR)
NIH
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Principal Investigators
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Jeffrey Wagener, M.D.
Role: PRINCIPAL_INVESTIGATOR
The Children's Hospital
Richard Moss, M.D.
Role: PRINCIPAL_INVESTIGATOR
Stanford University/Lucille Packard Children's Health Services at Stanford
Robert Wilmott, M.D.
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital & Medical Center
Michael Konstan, M.D.
Role: PRINCIPAL_INVESTIGATOR
Rainbow Babies and Children's Hospital
Pamela Zeitlin, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
David Waltz, M.D.
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
George Retsch-Bogart, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Peter Hiatt, M.D.
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Ronald Gibson, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Regional Medical Center
Locations
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Stanford University/Lucille Packard Children's Health Services at Stanford
Palo Alto, California, United States
The Children's Hospital
Denver, Colorado, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Children's Hospital
Boston, Massachusetts, United States
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Children's Hospital Medical Center
Cincinnati, Ohio, United States
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
Baylor College of Medicine
Houston, Texas, United States
Children's Hospital and Regional Medical Center
Seattle, Washington, United States
Countries
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References
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Ramsey BW, Pepe MS, Quan JM, Otto KL, Montgomery AB, Williams-Warren J, Vasiljev-K M, Borowitz D, Bowman CM, Marshall BC, Marshall S, Smith AL. Intermittent administration of inhaled tobramycin in patients with cystic fibrosis. Cystic Fibrosis Inhaled Tobramycin Study Group. N Engl J Med. 1999 Jan 7;340(1):23-30. doi: 10.1056/NEJM199901073400104.
Other Identifiers
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