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
3 other identifiers
interventional
98
1 country
9
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2000
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2000
CompletedFirst Submitted
Initial submission to the registry
September 11, 2000
CompletedFirst Posted
Study publicly available on registry
September 12, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2002
CompletedMarch 2, 2010
March 1, 2010
September 11, 2000
March 1, 2010
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Stanford University/Lucille Packard Children's Health Services at Stanford
Palo Alto, California, 94304, United States
The Children's Hospital
Denver, Colorado, 80218, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Children's Hospital
Boston, Massachusetts, 02115, United States
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Children's Hospital and Regional Medical Center
Seattle, Washington, 98105, United States
Related Publications (1)
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.
PMID: 9878641BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
Study Record Dates
First Submitted
September 11, 2000
First Posted
September 12, 2000
Study Start
February 1, 2000
Study Completion
February 1, 2002
Last Updated
March 2, 2010
Record last verified: 2010-03