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

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

— EARLY  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01082367
• Other study ID #: CTBM100C2304
• Secondary ID: 2009-016590-15
• Status: Active, not recruiting
• Phase: Phase 3
• First received: March 5, 2010
• Last updated: April 14, 2015
• Start date: April 2010
• Est. completion date: July 2015

Study information

• Verified date: April 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Ministry of HealthCanada: Health CanadaEgypt: Ministry of HealthFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: BfArM (Federal Institute for Drugs and Medical Devices)Greece: National Organization of MedicinesHungary: National Institute of PharmacyItaly: Agenzia Italiana del FarmacoPoland: Ministry of Health, Ministry of Science and Higher Education, Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRomania: Ministry of Public HealthRussia: FSI Scientific Center of Expertise of Medical ApplicationSwitzerland: SwissmedicUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 51
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 6 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• TOBI
TOBI (tobramycin inhaled solution)
• Placebo to TOBI
Placebo to tobramycin

Locations

Country	Name	City	State
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Toronto	Ontario
Egypt	Novartis Investigative Site	Alexandria
France	Novartis Investigative Site	Bordeaux
France	Novartis Investigative Site	Paris
Germany	Novartis Investigative Site	Dresden
Greece	Novartis Investigative Site	Patras
Greece	Novartis Investigative Site	Thessaloniki	GR
Greece	Novartis Investigative Site	Thessaloniki	GR
Hungary	Novartis Investigative Site	Debrecen
Hungary	Novartis Investigative Site	Kaposvar
Hungary	Novartis Investigative Site	Szeged
Italy	Novartis Investigative Site	Milano	MI
Romania	Novartis Investigative Site	Bucuresti
Russian Federation	Novartis Investigative Site	Kazan
Russian Federation	Novartis Investigative Site	Voronezh
Russian Federation	Novartis Investigative Site	Yaroslavl
Switzerland	Novartis Investigative Site	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Canada,  Egypt,  France,  Germany,  Greece,  Hungary,  Italy,  Romania,  Russian Federation,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients P aeruginosa-free at 29 days		Day 29	No
Secondary	Proportion of subjects free from P. aeruginosa 28 days after termination of the 2nd treatment		Day 91	No
Secondary	To assess the safety profile of TOBI inhaled twice daily or placebo throughout the treatment period in subjects in this age group.		Day 91	Yes