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Phase III Randomized Study of the Inhalation of Tobramycin in Patients With Cystic Fibrosis

NCT00004829 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2015-03-25

No results posted yet for this study

Summary

OBJECTIVES: I. Determine the safety and efficacy of tobramycin in patients with cystic fibrosis who are chronically colonized with Pseudomonas aeruginosa.

II. Determine whether this treatment produces tobramycin-resistant bacteria at a frequency different from the placebo group and whether the emergence of resistance is associated with a lack of clinical response.

Conditions

Interventions

DRUG

tobramycin

Sponsors & Collaborators

  • FDA Office of Orphan Products Development

    lead FED

Principal Investigators

  • Alan Bruce Montgomery · Pathogenesis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1995-06-30
Completion
1998-05-31

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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 NCT00004829 on ClinicalTrials.gov