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Second Open Label Extension to Bridging Study CTBM100C2303

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.
ClinicalTrials.gov Identifier: NCT01069705
Recruitment Status : Completed
First Posted : February 17, 2010
Last Update Posted : February 23, 2017
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This is an open-label, single arm (uncontrolled) study in patients suffering from cystic fibrosis, who have completed their study participation in CTBM100C2303 and extension study one CTBM100C2303E1 (all visits), who were proven infected with Pseudomonas aeruginosa at enrollment into CTBM100C2303.

Condition or disease Intervention/treatment Phase
Pulmonary Infections Pseudomonas Aeruginosa Drug: Tobramycin inhalation powder Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
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) Patients Who Completed Participation in Study CTBM100C2303E1.
Study Start Date : February 2010
Primary Completion Date : April 2012
Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: TIPnew Drug: Tobramycin inhalation powder
Tobramycin inhaled powder

Primary Outcome Measures :
  1. Safety of tobramycin inhalation powder for the treatment of infections with P. aeruginosa in patients suffering from cystic fibrosis. [ Time Frame: Each visit during the 168-day treatment period ]

Secondary Outcome Measures :
  1. Efficacy of tobramycin inhalation powder, assessed by FEV1 , FVC and FEF25-75 profile. [ Time Frame: Each visit during the 168-day treatment period ]
  2. Density of microorganisms in sputum samples [ Time Frame: Each visit during the 168-day treatment period ]

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

Inclusion Criteria:

  • Completed all visits in study CTBM100C2303 and CTBM100C2303E1, and visit 11 of study CTBM100C2303E1 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 (at start of 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 trial CTMB100C2303E1 and the enrollment into this study.
  • Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.

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): NCT01069705

Novartis Investigative Site
Pleven, Bulgaria
Novartis Investigative Site
Polvdiv, Bulgaria
Novartis Investigative Site
Sofia, Bulgaria
Novartis Investigative Site
Varna, Bulgaria
Novartis Investigative Site
Tallin, Estonia
Novartis Investigative Site
Tartu, Estonia
Novartis Investigative Site
Riga, Latvia
Novartis Investigative Site
Kaunas, Lithuania
Novartis Investigative Site
Vilnius, Lithuania
Novartis Investigative Site
Bucharest, Romania
Novartis Investigative Site
Timisoara, Romania
Russian Federation
Novartis Investigative Site
Kazan, Russian Federation
Novartis Investigative Site
Moscow, Russian Federation
Novartis Investigative Site
Saint Petersburg, Russian Federation
Novartis Investigative Site
Samara, Russian Federation
Novartis Investigative Site
Yaroslavl, Russian Federation
South Africa
Novartis Investigative Site
Durban, South Africa
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01069705     History of Changes
Other Study ID Numbers: CTBM100C2303E2
First Posted: February 17, 2010    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Tobramycin Inhalation Powder
Cystic fibrosis
Lung diseases
Anti-Bacterial Agents
Treatment of pulmonary infections with P. aeruginosa in cystic fibrosis patients

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