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

March 1, 2010 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

A Phase II Multicenter Randomized Trial of Tobramycin for Inhalation in Young Children With Cystic Fibrosis

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

98

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University/Lucille Packard Children's Health Services at Stanford
    • Colorado
      • Denver, Colorado, United States, 80218
        • The Children's Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Children's Hospital
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina - Chapel Hill
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Children's Hospital Medical Center
      • Cleveland, Ohio, United States, 44106
        • Rainbow Babies and Children's Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
    • Washington
      • Seattle, Washington, United States, 98105
        • Children's Hospital and Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age at least 6 months and less than 6 years
  • Diagnosis of cystic fibrosis with 2 clinical features consistent with CF and confirmed by either sweat chloride >= 60 mEq/L (by quantitative pilocarpine iontophoresis) or by genotype with 2 identifiable mutations consistent with CF.
  • One throat or sputum microbiology culture positive for Pseudomonas aeruginosa (Pa) within 2 weeks to 12 months prior to screening.
  • Informed consent by parent or legal guardian.

Exclusion Criteria:

  • History of adverse reaction to anesthesia or sedation.
  • History of aminoglycoside hypersensitivity.
  • History of unresolved anemia (hematocrit < 30%) or thrombocytopenia (platelet count < 100,000/mm3).
  • History of hemoptysis with 30 days prior to screening.
  • History of abnormal renal function (serum creatinine > 1.5 times the upper limit of normal for age).
  • History of clinically documented chronic hearing loss.
  • Administration of any investigational drug within 30 days prior to screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

National Center for Research Resources (NCRR)

Investigators

  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2000

Study Completion

February 1, 2002

Study Registration Dates

First Submitted

September 11, 2000

First Submitted That Met QC Criteria

September 11, 2000

First Posted (Estimate)

September 12, 2000

Study Record Updates

Last Update Posted (Estimate)

March 2, 2010

Last Update Submitted That Met QC Criteria

March 1, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Inhaled Tobramycin (completed)
  • 1R01DK057755-01 (U.S. NIH Grant/Contract)
  • M01RR000037 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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