A Study of the Safety and Efficacy of Tobramycin for Inhalation in Young Children With Cystic Fibrosis
Public ClinicalTrials.gov record NCT00006280. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II Multicenter Randomized Trial of Tobramycin for Inhalation in Young Children With Cystic Fibrosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT00006280
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 98 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Months to 5 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2000
- Primary completion
- Not listed
- Completion
- Jan 31, 2002
- Last update posted
- Mar 1, 2010
2000 – 2002
United States locations
- U.S. sites
- 9
- U.S. states
- 8
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Stanford University/Lucille Packard Children's Health Services at Stanford | Palo Alto | California | 94304 | — |
| The Children's Hospital | Denver | Colorado | 80218 | — |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | — |
| Children's Hospital | Boston | Massachusetts | 02115 | — |
| University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| Rainbow Babies and Children's Hospital | Cleveland | Ohio | 44106 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| Children's Hospital and Regional Medical Center | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00006280, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 1, 2010 · Synced Sep 21, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00006280 live on ClinicalTrials.gov.