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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01082367
First received: March 5, 2010
Last updated: August 29, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention Phase
Treatment of Early Pulmonary Infections With P. Aeruginosa in Cystic Fibrosis Patients
Drug: TOBI
Drug: Placebo to TOBI
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Proportion of patients P aeruginosa-free at 29 days [ Time Frame: Day 29 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects free from P. aeruginosa 28 days after termination of the 2nd treatment [ Time Frame: Day 91 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: April 2010
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TOBI (tobramycin inhaled solution)
TOBI (tobramycin inhaled solution)
Drug: TOBI
TOBI (tobramycin inhaled solution)
Placebo Comparator: Placebo
Placebo to tobramycin
Drug: Placebo to TOBI
Placebo to tobramycin

  Eligibility

Ages Eligible for Study:   3 Months to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01082367

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

  Show 45 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01082367     History of Changes
Other Study ID Numbers: CTBM100C2304, 2009-016590-15
Study First Received: March 5, 2010
Last Updated: August 29, 2014
Health Authority: Argentina: Ministry of Health
Canada: Health Canada
Egypt: Ministry of Health
France: 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 Medicines
Hungary: National Institute of Pharmacy
Italy: Agenzia Italiana del Farmaco
Poland: Ministry of Health, Ministry of Science and Higher Education, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: Ministry of Public Health
Russia: FSI Scientific Center of Expertise of Medical Application
Switzerland: Swissmedic
United States: Food and Drug Administration

Keywords provided by Novartis:
Tobramycin Inhalation solution
Cystic fibrosis
Lung disease
anti-bacterial agents

Additional relevant MeSH terms:
Communicable Diseases
Cystic Fibrosis
Fibrosis
Infection
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Lung Diseases
Pancreatic Diseases
Pathologic Processes
Respiratory Tract Diseases
Pharmaceutical Solutions
Tobramycin
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014