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.

ovartis Pharma Services AG0 sites100 target enrollmentJanuary 22, 2009

Overview

No summary available.

Registry

who.int

Start Date

January 22, 2009

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Main inclusion criteria (refer to full protocol for comprehensive list)
•Written informed consent given by adult subjects or by the parents/legal guardian on behalf of the subject in combination with the subject’ s assent, if capable of assenting, before any assessment is performed.
•Completed all visits in study CTBM100C2303, and visit 4 of CTBM100C2303 took place not more than 5 days before enrollment into this study.
•Able to comply with all protocol requirements.
•Use of an effective means of contraception in women of childbearing potential.
•Clinically stable in the opinion of the investigator to be treated according to this protocol.
•cough swab culture (or bronchoalveolar lavage \[BAL]) within 6 months prior to screening and in the sputum/ deep\-throat cough swab culture at the screening visit.
•Able to expectorate a sputum sample at screening.
•Use of an effective means of contraception in females of childbearing potential.
•Clinically stable in the opinion of the investigator to be treated according to this protocol.

•Main exclusion criteria (refer to full protocol for comprehensive list)
•Any use of inhaled anti\-pseudomonal antibiotics between the termination of the core trial CTMB100C2303 and the enrollment into this study.
•Any use of systemic anti\-pseudomonal antibiotics between the termination of the core trial CTMB100C2303 and the enrollment into this study.
•Serum creatinine 2 mg/dl or above, BUN 40 mg/dl or above, or an abnormal urinalysis defined as 2\+ or greater proteinuria.
•Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
•Signs and symptoms of acute pulmonary disease, e.g., pneumonia, pneumothorax.
•Administration of any investigational drug within 30 days prior to enrollment (except for study medication in CTBM100C2303\).
•Any previous exposure to tobramycin dry powder for inhalation (TIP), with the exception of study medication for study CTMB100C2303\.
•Administration of loop diuretics within 7 days prior to study drug administration.
•Initiation of treatment with chronic macrolide therapy between the termination of the core trial CTMB100C2303 and the enrollment into this study (subjects may be taking chronic macrolide therapy at the time of enrollment into CTBM100C2303E1, but they must have initiated treatment more than 28 days prior to study drug administration for CTBM100C2303 and the dosage/regimen must remain stable throught the study).