This is an open-label, single arm (uncontrolled) study in patients suffering from cystic fibrosis;who have completed their study participation in extension study one CTBM100C2303E1.

Phase 3

Completed

• Conditions: Pulmonary InfectionsPseudomonas Aeruginosa

• Registration Number: CTRI/2011/09/002020
• Lead Sponsor: Novartis Healthcare Pvt Ltd

Brief Summary

Purpose of Study: This is an open-label, single arm (uncontrolled) study in patients suffering from cystic fibrosis, who have completed their study participation in CTBM100C2303 (CTRI/2010/091/001399) and extension study one CTBM100C2303E1(CTRI/2011/04/001664) (all visits), who were proven infected with Pseudomonas aeruginosa at enrollment into CTBM100C2303.

FPFV: 19-Sept-2011

Enrollment Target for India: 01

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-30
• Last Update Posted: 2012-02-05

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 140

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 percentage and 80 percentage 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety of tobramycin inhalation powder for the treatment of infections with P. aeruginosa in patients suffering from cystic fibrosis.	Each visit during the 168-day treatment period

Secondary Outcome Measures

Name	Time	Method
1.Efficacy of tobramycin inhalation powder, assessed by FEV1 , FVC and FEF25-75 profile.	2.Density of microorganisms in sputum samples

Trial Locations

Locations (1)

Christian Medical College; 🇮🇳 Vellore, TAMIL NADU, India

Christian Medical College

🇮🇳Vellore, TAMIL NADU, India

Dr D J Christopher

Principal investigator

919443306573

pulmedcmc@gmail.com