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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK057755-01 | U.S. NIH Grant/Contract | View source | |
| M01RR000037 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Research Resources (NCRR) | NIH |
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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tobramycin for Inhalation | Drug |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University/Lucille Packard Children's Health Services at Stanford | Palo Alto | California | 94304 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9878641 | Background | 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. |
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| 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 |
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
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| ID | Term |
|---|---|
| D014031 | Tobramycin |
| D001239 | Inhalation |
| ID | Term |
|---|---|
| D009328 | Nebramycin |
| D007612 | Kanamycin |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D015656 | Respiratory Mechanics |
| D012119 | Respiration |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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