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Clinical trialNCT00006280CompletedPhase 2Interventional

A Study of the Safety and Efficacy of Tobramycin for Inhalation in Young Children With Cystic Fibrosis

SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Enrollment98Cystic Fibrosis
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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).

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

9 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Stanford University/lucille Packard Children'S Health Services at Stanford

    Palo Alto, California, United States

  • the Children'S Hospital

    Denver, Colorado, United States

  • Johns Hopkins Hospital

    Baltimore, Maryland, United States

  • Children'S Hospital

    Boston, Massachusetts, United States

  • University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, United States

  • Children'S Hospital Medical Center

    Cincinnati, Ohio, United States

  • Rainbow Babies and Children'S Hospital

    Cleveland, Ohio, United States

  • Baylor College of Medicine

    Houston, Texas, United States

  • Children'S Hospital and Regional Medical Center

    Seattle, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Tobramycin for Inhalation
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
29 Feb 2000
Primary completion
—
Completion
28 Feb 2002
Last update posted
2 Mar 2010
Registered enrollment
98
Registry id
NCT00006280

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.