DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Open Label Extension to Bridging Study CTBM100C2303

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pseudomonas Aeruginosa; Cystic Fibrosis

Intervention: Tobramycin inhalation powder (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Summary

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.

Clinical Details

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.

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Safety of tobramycin inhalation powder for the treatment of infections with P. aeruginosa in subjects suffering from cystic fibrosis.

Secondary outcome:

Efficacy of tobramycin inhalation powder, assessed by spirometry

Density of microorganisms in sputum samples

Eligibility

Minimum age: 6 Years. Maximum age: 21 Years. Gender(s): Both.

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.

Locations and Contacts

Novartis Investigative Site, Tallin, Estonia

Novartis Investigative Site, Yaroslavl, Russian Federation

Additional Information

Starting date: August 2009
Last updated: May 2, 2012

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017