Efficacy and Safety of 28 or 56 Days Treatment With Inhaled Tobramycin Nebuliser Solution for Pseudomonas Aeruginosa Infection in Children With Cystic Fibrosis.

This study has been completed.

First Received: October 19, 2006 Last Updated: March 19, 2009 History of Changes

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00391976

Purpose

This study assesses time to recurrence of infection with Pseudomonas aeruginosa following treatment of the initial infection with tobramycin nebuliser solution. The safety of the initial tobramycin treatment will be monitored over the first 3 months of the study and patients will be followed for a further 24 months.

Condition	Intervention	Phase
Cystic Fibrosis	Drug: Tobramycin Nebulised Solution	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Microbiologic Efficacy and Safety of Two Treatment Regimens of Inhaled Tobramycin Nebuliser Solution (TNS) for the Treatment of Early Onset Pseudomonas Aeruginosa Lower Respiratory Tract Infection in Subjects With Cystic Fibrosis.

Resource links provided by NLM:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

Drug Information available for: Tobramycin Tobramycin sulfate

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Median time to recurrence of infection with Pseudomonas aeruginosa

Secondary Outcome Measures:

Proportion of patients without P. aeruginosa diagnosis one month after finishing tobramycin treatment; Days in hospital and number of hospital admissions;
Incidence of adverse events; Change in serum creatinine; Levels of tobramycin in serum; Change in hearing ability

Estimated Enrollment:	121
Study Start Date:	November 2003
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Tobramycin Nebulised Solution
2: Active Comparator	Drug: Tobramycin Nebulised Solution

Eligibility

Ages Eligible for Study:	6 Months and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Written informed consent by subject and/or parent /legal guardian
Male or female subjects at least 6 months old
Diagnosis of cysticfibrosis based on first or early lower respiratory tract infection with P. aeruginosa documented by either first P. aeruginosa isolated from sputum or deep throat cough swab culture or by P. aeruginosa from sputum or deep throat cough swab culture following at least 1 or 2 years of negative cultures and no anti-pseudomonal treatment during this period.

Exclusion Criteria:

History of aminoglycoside hypersensitivity or adverse reaction to inhaled aminoglycoside
Signs and symptoms of acute pulmonary disease such as pneumonia or pneumothorax
Administration of any investigational drug within 30 days prior to enrollment.
Administration of loop diuretics within 7 days prior to study drug administration.
Personal/family history of abnormal hearing
Abnormal result from an audiology testing
Positive urine pregnancy test
Use of macrolide antibiotics as a maintenance therapy for 12 or more days during the 28 days prior to Visit 1.

Other protocol specific inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391976

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

David Spencer

Royal Victoria Infirmary

More Information

No publications provided

Responsible Party:	novartis ( external affairs )
Study ID Numbers:	CTBM100B2301
Study First Received:	October 19, 2006
Last Updated:	March 19, 2009
ClinicalTrials.gov Identifier:	NCT00391976 History of Changes
Health Authority:	Austria: Agency for Health and Food Safety; Germany: Federal Institute for Drugs and Medical Devices; Spain: Spanish Agency of Medicines; France: Afssaps - French Health Products Safety Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Italy: National Institute of Health; Netherlands: Medicines Evaluation Board (MEB); Portugal: National Pharmacy and Medicines Institute

Keywords provided by Novartis:

Cystic Fibrosis, Tobramycin Nebulised Solution, Pseudomonas aeruginosa

Additional relevant MeSH terms:

Anti-Infective Agents
Tobramycin
Fibrosis
Infection
Pharmacologic Actions
Anti-Bacterial Agents
Digestive System Diseases
Pathologic Processes

Cystic Fibrosis
Respiratory Tract Infections
Respiratory Tract Diseases
Genetic Diseases, Inborn
Therapeutic Uses
Lung Diseases
Pancreatic Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on February 08, 2010