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Open Label Extension to Bridging Study CTBM100C2303

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00982930
First Posted: September 23, 2009
Last Update Posted: November 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  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: None (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:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

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 ]

Secondary Outcome Measures:
  • Efficacy of tobramycin inhalation powder, assessed by spirometry [ Time Frame: Each visit during the 168-day treatment period ]
  • Density of microorganisms in sputum samples [ Time Frame: Each visit (except last visit) during the 168-day treatment period ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00982930


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

Additional Information:
Publications:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00982930     History of Changes
Other Study ID Numbers: CTBM100C2303E1
EudraCT 2008-004764-39
First Submitted: September 21, 2009
First Posted: September 23, 2009
Last Update Posted: November 16, 2016
Last Verified: April 2016

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

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