Overview

This trial is active, not recruiting.

Condition treatment of early pulmonary infections with p. aeruginosa in cystic fibrosis patients
Treatments tobi, placebo to tobi
Phase phase 3
Sponsor Novartis Pharmaceuticals
Start date April 2010
End date July 2015
Trial size 51 participants
Trial identifier NCT01082367, 2009-016590-15, CTBM100C2304

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
TOBI (tobramycin inhaled solution)
tobi
TOBI (tobramycin inhaled solution)
(Placebo Comparator)
Placebo to tobramycin
placebo to tobi
Placebo to tobramycin

Primary Outcomes

Measure
Proportion of patients P aeruginosa-free at 29 days
time frame: Day 29

Secondary Outcomes

Measure
Proportion of subjects free from P. aeruginosa 28 days after termination of the 2nd treatment
time frame: Day 91
To assess the safety profile of TOBI inhaled twice daily or placebo throughout the treatment period in subjects in this age group.
time frame: Day 91

Eligibility Criteria

Male or female participants from 3 months up to 6 years old.

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

Additional Information

Official title A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. Aeruginosa in Cystic Fibrosis Subjects Aged From 3 Months to Less Than 7 Years
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Novartis.