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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Tobramycin for Inhalation

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Cystic Fibrosis

Eligibility Criteria

6 Months - 5 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Stanford University/Lucille Packard Children's Health Services at Stanford
The Children's Hospital
Johns Hopkins Hospital
Children's Hospital
University of North Carolina - Chapel Hill
Children's Hospital Medical Center
Rainbow Babies and Children's Hospital
Baylor College of Medicine
Children's Hospital and Regional Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00006280

First Posted

September 11, 2000

Last Updated

March 1, 2010

Sponsor

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

Collaborators

National Center for Research Resources (NCRR)

1. Study Identification

Unique Protocol Identification Number

NCT00006280

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2010

Overall Recruitment Status

Completed

Study Start Date

February 2000 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

February 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

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

Collaborators

National Center for Research Resources (NCRR)

4. Oversight

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis

Keywords

Cystic Fibrosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Masking

Double

Allocation

Randomized

Enrollment

98 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Tobramycin for Inhalation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

5 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Overall Study Officials: