A Study of the Safety and Efficacy of Tobramycin for Inhalation in Young Children With Cystic Fibrosis

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00006280
First received: September 11, 2000
Last updated: March 1, 2010
Last verified: March 2010
  Purpose

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).


Condition Intervention Phase
Cystic Fibrosis
Drug: Tobramycin for Inhalation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase II Multicenter Randomized Trial of Tobramycin for Inhalation in Young Children With Cystic Fibrosis

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Estimated Enrollment: 98
Study Start Date: February 2000
Estimated Study Completion Date: February 2002
  Eligibility

Ages Eligible for Study:   6 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006280

Locations
United States, California
Stanford University/Lucille Packard Children's Health Services at Stanford
Palo Alto, California, United States, 94304
United States, Colorado
The Children's Hospital
Denver, Colorado, United States, 80218
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Children's Hospital
Boston, Massachusetts, United States, 02115
United States, North Carolina
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Washington
Children's Hospital and Regional Medical Center
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Investigators
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 Medical Center, Cincinnati
Principal Investigator: George Retsch-Bogart, M.D. 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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00006280     History of Changes
Other Study ID Numbers: Inhaled Tobramycin (completed), 1-R01-DK57755-01, M01 RR 00037
Study First Received: September 11, 2000
Last Updated: March 1, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Cystic Fibrosis

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Tobramycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014