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Second Open Label Extension to Bridging Study CTBM100C2303

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01069705
First received: February 15, 2010
Last updated: February 21, 2017
Last verified: February 2017
February 15, 2010
February 21, 2017
February 2010
April 2012   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01069705 on ClinicalTrials.gov Archive Site
  • Efficacy of tobramycin inhalation powder, assessed by FEV1 , FVC and FEF25-75 profile. [ Time Frame: Each visit during the 168-day treatment period ]
  • Density of microorganisms in sputum samples [ Time Frame: Each visit during the 168-day treatment period ]
Same as current
Not Provided
Not Provided
 
Second Open Label Extension to Bridging Study CTBM100C2303
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.
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.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Pulmonary Infections
  • Pseudomonas Aeruginosa
Drug: Tobramycin inhalation powder
Tobramycin inhaled powder
Experimental: TIPnew
Intervention: Drug: Tobramycin inhalation powder
Konstan MW, Flume PA, Galeva I, Wan R, Debonnett LM, Maykut RJ, Angyalosi G. One-year safety and efficacy of tobramycin powder for inhalation in patients with cystic fibrosis. Pediatr Pulmonol. 2016 Apr;51(4):372-8. doi: 10.1002/ppul.23358. Epub 2015 Dec 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
April 2012
April 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
6 Years to 21 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   Estonia,   Latvia,   Lithuania,   Romania,   Russian Federation,   South Africa
 
 
NCT01069705
CTBM100C2303E2
Not Provided
Not Provided
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP