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: May 2, 2012

Last verified: May 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	February 15, 2010
Last Updated Date	May 2, 2012
Start Date ^ICMJE	February 2010
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 16, 2010)	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 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01069705 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 16, 2010)	Efficacy of tobramycin inhalation powder, assessed by FEV1 , FVC and FEF25-75 profile. [ 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 during the 168-day treatment period ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Second Open Label Extension to Bridging Study CTBM100C2303
Official Title ^ICMJE	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.
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Pulmonary Infections Pseudomonas Aeruginosa
Intervention ^ICMJE	Drug: Tobramycin inhalation powder Tobramycin inhaled powder
Study Arm (s)	Experimental: TIPnew Intervention: Drug: Tobramycin inhalation powder
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	49
Completion Date	April 2012
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	6 Years to 21 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Bulgaria, Estonia, Latvia, Lithuania, Romania, Russian Federation, South Africa

Administrative Information
NCT Number ^ICMJE	NCT01069705
Other Study ID Numbers ^ICMJE	CTBM100C2303E2
Has Data Monitoring Committee	Not Provided
Responsible Party	Novartis ( Novartis Pharmaceuticals )
Study Sponsor ^ICMJE	Novartis Pharmaceuticals
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Novartis
Verification Date	May 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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