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Open Label Extension to Bridging Study CTBM100C2303

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00982930
First received: September 21, 2009
Last updated: May 2, 2012
Last verified: May 2012
History of Changes
  Purpose

This is an open-label, single arm (uncontrolled) study in subjects suffering from cystic fibrosis, who have completed their study participation in CTBM100C2303 (all visits) and who were proven infected with Pseudomonas aeruginosa at enrollment into CTBM100C2303.


Condition Intervention Phase
Pseudomonas Aeruginosa
Cystic Fibrosis
 Drug: Tobramycin inhalation powder
 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Open-label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder After Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303.

Resource links provided by NLM:

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Safety of tobramycin inhalation powder for the treatment of infections with P. aeruginosa in subjects suffering from cystic fibrosis. [ Time Frame: Each visit during the 168-day treatment period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy of tobramycin inhalation powder, assessed by spirometry [ Time Frame: Each visit during the 168-day treatment period ] [ Designated as safety issue: No ]
  • Density of microorganisms in sputum samples [ Time Frame: Each visit (except last visit) during the 168-day treatment period ] [ Designated as safety issue: No ]

Enrollment: 57
Study Start Date: August 2009
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TIPnew Drug: Tobramycin inhalation powder
Tobramycin inhaled powder

  Eligibility

Ages Eligible for Study:   6 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Completed all visits in study CTBM100C2303, and visit 4 took place not more than 5 days before enrollment into this study.
  • Confirmed diagnosis of cystic fibrosis patients with P. aeruginosa infection.
  • FEV1 at screening (study CTBM100C2303) must be between 25% and 80% of normal predicted values.

Exclusion Criteria:

  • Any use of inhaled anti-pseudomonal antibiotics between the termination of the core trial CTMB100C2303 and the enrollment into this study.
  • Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00982930

Locations
Estonia
Novartis Investigative Site
Tallin, Estonia
Russian Federation
Novartis Investigative Site
Yaroslavl, Russian Federation
Sponsors and Collaborators
Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00982930     History of Changes
Other Study ID Numbers: CTBM100C2303E1, EudraCT 2008-004764-39
Study First Received: September 21, 2009
Last Updated: May 2, 2012
Health Authority: Estonia: The State Agency of Medicine
Russia: Ministry of Health of the Russian Federation
United States: Food and Drug Administration

Keywords provided by Novartis:
Tobramycin Inhalation Powder
Cystic fibrosis
Lung diseases
Anti-Bacterial Agents

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pseudomonas Infections
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
 Pathologic Processes
Gram-Negative Bacterial Infections
Bacterial Infections
Tobramycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013