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

NCT00006280 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2010-03-02

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Tobramycin for Inhalation

Sponsors & Collaborators

  • National Center for Research Resources (NCRR)

    collaborator NIH

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Jeffrey Wagener, M.D. · The Children's Hospital

  • Richard Moss, M.D. · Stanford University/Lucille Packard Children's Health Services at Stanford

  • Robert Wilmott, M.D. · Children's Hospital & Medical Center

  • Michael Konstan, M.D. · Rainbow Babies and Children's Hospital

  • Pamela Zeitlin, M.D., Ph.D. · Johns Hopkins University

  • David Waltz, M.D. · Children's Hospital Medical Center, Cincinnati

  • George Retsch-Bogart, M.D. · University of North Carolina, Chapel Hill

  • Peter Hiatt, M.D. · Baylor College of Medicine

  • Ronald Gibson, M.D., Ph.D. · Children's Hospital Regional Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE

Eligibility

Min Age
6 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-02-29
Completion
2002-02-28

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00006280 on ClinicalTrials.gov