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Second 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: Pulmonary Infections; Pseudomonas Aeruginosa

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 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.

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) Patients Who Completed Participation in Study CTBM100C2303E1.

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 patients suffering from cystic fibrosis.

Secondary outcome:

Efficacy of tobramycin inhalation powder, assessed by FEV1 , FVC and FEF25-75 profile.

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 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.

Locations and Contacts

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

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

Novartis Investigative Site, Durban, South Africa

Additional Information

Starting date: February 2010
Last updated: May 2, 2012

Page last updated: August 23, 2015

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