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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01082367
First received: March 5, 2010
Last updated: March 24, 2016
Last verified: March 2016
  Purpose
This study investigated 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
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:
  • Percentage of Participants P Aeruginosa-free After Completion of the First Treatment Cycle [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
    Sputum/throat swab cultures were assessed.


Secondary Outcome Measures:
  • Percentage of Participants Free From P. Aeruginosa 28 Days After Termination of the Second Treatment Cycle [ Time Frame: Day 91 ] [ Designated as safety issue: No ]
    Sputum/throat swab cultures were assessed.

  • Percentage of Participants P Aeruginosa-free 28 Days After Termination of the Second Treatment Cycle [ Time Frame: Day 91 ] [ Designated as safety issue: No ]
    Sputum/throat swab cultures were assessed.


Enrollment: 50
Study Start Date: April 2010
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TOBI (tobramycin inhaled solution)/Placebo
Participants randomized to TOBI received the investigational treatment for 28 days twice daily (bi)d in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the open label (OL) phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received placebo for 28 days bid (second treatment cycle).
Drug: TOBI
TOBI (tobramycin inhaled solution)
Drug: Placebo
Placebo
Placebo Comparator: Placebo/TOBI
Participants randomized to placebo group received 0.9 % saline (NaCl) for 28 days bid in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the OL phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received TOBI for 28 days bid (second treatment cycle).
Drug: TOBI
TOBI (tobramycin inhaled solution)
Drug: Placebo
Placebo

  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

Locations
Canada, Ontario
Novartis Investigative Site
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
Novartis Investigative Site
Montreal, Quebec, Canada, H3T1C5
Egypt
Novartis Investigative Site
Alexandria, Egypt, 21131
France
Novartis Investigative Site
Bordeaux, France, 33076
Novartis Investigative Site
Paris, France, 75019
Germany
Novartis Investigative Site
Dresden, Germany, 01307
Greece
Novartis Investigative Site
Thessaloniki, GR, Greece, 546 39
Novartis Investigative Site
Thessaloniki, GR, Greece, 546 29
Novartis Investigative Site
Patras, Greece, 265 00
Hungary
Novartis Investigative Site
Debrecen, Hungary, 4032
Novartis Investigative Site
Debrecen, Hungary, 4043
Novartis Investigative Site
Kaposvar, Hungary, 7400
Novartis Investigative Site
Szeged, Hungary, 6725
Italy
Novartis Investigative Site
Milano, MI, Italy, 20122
Romania
Novartis Investigative Site
Bucuresti, Romania, 20395
Russian Federation
Novartis Investigative Site
Kazan, Russian Federation, 420012
Novartis Investigative Site
Voronezh, Russian Federation, 394036
Novartis Investigative Site
Yaroslavl, Russian Federation, 150003
Switzerland
Novartis Investigative Site
Zürich, Switzerland, 8032
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

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
Results First Received: December 22, 2015
Last Updated: March 24, 2016
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:
Cystic Fibrosis
Fibrosis
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Lung Diseases
Pancreatic Diseases
Pathologic Processes
Respiratory Tract Diseases
Tobramycin
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on April 27, 2016