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| Sponsors and Collaborators: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Center for Research Resources (NCRR) |
| Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| ClinicalTrials.gov Identifier: | NCT00006280 |
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 II |
| Genetics Home Reference related topics: | cystic fibrosis |
| MedlinePlus related topics: | Cystic Fibrosis |
| Drug Information available for: | Tobramycin Tobramycin sulfate |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
| Official Title: | A Phase II Multicenter Randomized Trial of Tobramycin for Inhalation in Young Children With Cystic Fibrosis |
Eligibility
| Ages Eligible for Study: | 6 Months to 5 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 | |||||
| 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 |
More Information
| Study ID Numbers: | Inhaled Tobramycin in CF, 1-R01-DK57755-01, M01 RR 00037 |
| First Received: | September 11, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00006280 |
| Health Authority: | United States: Federal Government |
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