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

FDA Office of Orphan Products Development200 enrolled

Overview

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.

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients receive tobramycin or placebo by inhalation twice daily for 28 days followed by 28 days of rest. This treatment is repeated twice, for a total of 3 courses of therapy. Patients are followed every 2 weeks for the first 8 weeks, then every 4 weeks, and then at 4 weeks after the last treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

200

Conditions

Cystic Fibrosis Bacterial Infection

Interventions

tobramycinDRUG

Eligibility

Sex: ALLMin age: 6 Years

Medical Language ↔ Plain English

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Documented cystic fibrosis with Pseudomonas aeruginosa present in a sputum or throat culture within 6 months prior to screening Sweat chloride at least 60 mEq/L --Prior/Concurrent Therapy-- At least 14 days since prior intravenous or aerosolized tobramycin or other antipseudomonal antibiotic At least 4 weeks since prior administration of any investigational drug No concurrent antibiotics by aerosol --Patient Characteristics-- Renal: * Creatinine less than 2 mg/dL * BUN less than 40 mg/dL * No proteinuria of 2+ or greater Pulmonary: * FEV1 at least 75% and at least 25% of predicted * Room air oximetry at least 88% saturation * Able to perform pulmonary function tests * No hemoptysis of 60 mL or greater within 30 days prior to study * No abnormal chest X-ray Other: * Not pregnant * Fertile females must use effective contraception * No history of positive culture with Burkholderia cepacia * No history of glucose-6-phosphate dehydrogenase deficiency * No known local or systemic hypersensitivity to aminoglycosides, albuterol, or other beta-2 agonists

Data from ClinicalTrials.gov

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