Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years

Novartis Pharmaceuticals50 enrolled

Overview

This study investigated the efficacy of inhaled TOBI treatment for early infections of P. aeruginosa in paediatric patients with cystic fibrosis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Treatment of Early Pulmonary Infections With P. Aeruginosa in Cystic Fibrosis Patients

Interventions

TOBIDRUG

TOBI (tobramycin inhaled solution)

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 6 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of cystic fibrosis * Early lower respiratory tract infection with P. aeruginosa, Exclusion Criteria: * Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics. * Administration of loop diuretics within 7 days prior to study drug administration. * Other protocol-defined inclusion/exclusion criteria may apply

Locations (19)

Novartis Investigative Site

Toronto, Ontario, Canada

Novartis Investigative Site

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

Percentage of Participants P Aeruginosa-free After Completion of the First Treatment Cycle

Sputum/throat swab cultures were assessed.

Time frame: Day 29

Secondary Outcomes

Percentage of Participants Free From P. Aeruginosa 28 Days After Termination of the Second Treatment Cycle

Sputum/throat swab cultures were assessed.

Time frame: Day 91

Percentage of Participants P Aeruginosa-free at Termination of the Double Blind Period

Sputum/throat swab cultures were assessed.

Time frame: Day 91

Data from ClinicalTrials.gov

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