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| Tracking Information | |||||||||||||||||||||||||||||||||||||
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| First Received Date ICMJE | September 11, 2000 | ||||||||||||||||||||||||||||||||||||
| Last Updated Date | June 23, 2005 | ||||||||||||||||||||||||||||||||||||
| Start Date ICMJE | February 2000 | ||||||||||||||||||||||||||||||||||||
| Primary Completion Date | |||||||||||||||||||||||||||||||||||||
| Current Primary Outcome Measures ICMJE | |||||||||||||||||||||||||||||||||||||
| Original Primary Outcome Measures ICMJE | |||||||||||||||||||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT00006280 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||||||||||||||||||||||||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||||||||||||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||||||||||||||||||
| Brief Title ICMJE | A Study of the Safety and Efficacy of Tobramycin for Inhalation in Young Children With Cystic Fibrosis | ||||||||||||||||||||||||||||||||||||
| Official Title ICMJE | A Phase II Multicenter Randomized Trial of Tobramycin for Inhalation in Young Children With Cystic Fibrosis | ||||||||||||||||||||||||||||||||||||
| 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). |
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| Detailed Description | |||||||||||||||||||||||||||||||||||||
| Study Phase | Phase II | ||||||||||||||||||||||||||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||||||||||||||||||||||||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control | ||||||||||||||||||||||||||||||||||||
| Condition ICMJE | Cystic Fibrosis | ||||||||||||||||||||||||||||||||||||
| Intervention ICMJE | Drug: Tobramycin for Inhalation | ||||||||||||||||||||||||||||||||||||
| Study Arms / Comparison Groups | |||||||||||||||||||||||||||||||||||||
| Publications * | 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. | ||||||||||||||||||||||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||||||||||||||||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||||||||||||||||||||||||||
| Enrollment ICMJE | 98 | ||||||||||||||||||||||||||||||||||||
| Completion Date | February 2002 | ||||||||||||||||||||||||||||||||||||
| Primary Completion Date | |||||||||||||||||||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||||||||||||||||||||||||||
| Ages | 6 Months to 5 Years | ||||||||||||||||||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||||||||||||||||||
| Location Countries ICMJE | United States | ||||||||||||||||||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||||||||||||||||||
| NCT ID ICMJE | NCT00006280 | ||||||||||||||||||||||||||||||||||||
| Responsible Party | |||||||||||||||||||||||||||||||||||||
| Study ID Numbers ICMJE | Inhaled Tobramycin in CF, 1-R01-DK57755-01, M01 RR 00037 | ||||||||||||||||||||||||||||||||||||
| Study Sponsor ICMJE | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ||||||||||||||||||||||||||||||||||||
| Collaborators ICMJE | National Center for Research Resources (NCRR) | ||||||||||||||||||||||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ||||||||||||||||||||||||||||||||||||
| Verification Date | July 2003 | ||||||||||||||||||||||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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