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
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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:
Genetics Home Reference related topics:
cystic fibrosis
MedlinePlus related topics:
Cystic Fibrosis
U.S. FDA Resources
Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
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
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 May 21, 2013