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A Study of the Safety and Efficacy of Tobramycin for Inhalation in Young Children With Cystic Fibrosis
This study has been completed.
Study NCT00006280   Information provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First Received: September 11, 2000   Last Updated: June 23, 2005   History of Changes

September 11, 2000
June 23, 2005
February 2000
 
 
 
Complete list of historical versions of study NCT00006280 on ClinicalTrials.gov Archive Site
 
 
 
A Study of the Safety and Efficacy of Tobramycin for Inhalation in Young Children With Cystic Fibrosis
A Phase II Multicenter Randomized Trial of Tobramycin for Inhalation in Young Children With Cystic Fibrosis

This study's primary goals are to test the safety and effectiveness of Tobramycin for Inhalation (TOBIr) in cystic fibrosis (CF) patients who are between 6 months and 6 years of age. This drug is an antibiotic that is inhaled into the lungs by the patient. It has already been studied and approved by the FDA for treatment of CF patients 6 years and older. Lung fluid will be examined for bacteria before and after the 28-day treatment. The amount of bacteria before and after treatment will be compared. This will indicate whether the antibiotic was effective in killing bacteria in the lungs. Once treatment begins, patients will be monitored every 2 weeks throughout the study (5 exams in 56 days). Half of the patients will receive TOBIr, half will receive a placebo (a substance that looks like TOBIr but contains no medication).

 
Phase II
Interventional
Treatment, Randomized, Double-Blind, Placebo Control
Cystic Fibrosis
Drug: Tobramycin for Inhalation
 
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
98
February 2002
 

Inclusion Criteria:

  • Age at least 6 months and less than 6 years
  • 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 adverse reaction to anesthesia or sedation.
  • 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.
Both
6 Months to 5 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006280
 
Inhaled Tobramycin in CF, 1-R01-DK57755-01, M01 RR 00037
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Center for Research Resources (NCRR)
Principal Investigator: Jeffrey Wagener, M.D. The Children's Hospital
Principal Investigator: Richard Moss, M.D. Stanford University/Lucille Packard Children's Health Services at Stanford
Principal Investigator: Robert Wilmott, M.D. Children's Hospital Medical Center
Principal Investigator: Michael Konstan, M.D. Rainbow Babies and Children's Hospital
Principal Investigator: Pamela Zeitlin, M.D., Ph.D. Johns Hopkins University
Principal Investigator: David Waltz, M.D. Children's Hospital
Principal Investigator: George Retsch-Bogart, M.D. The University of North Carolina, Chapel Hill
Principal Investigator: Peter Hiatt, M.D. Baylor College of Medicine
Principal Investigator: Ronald Gibson, M.D., Ph.D. Children's Hospital Regional Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
July 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP