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.

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 - CTBM100C2303E1

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/04/001664

Enrollment

100

Registered

2011-04-05

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- 1.Pseudomonas Aeruginosa 2.Cystic Fibrosis

Interventions

Intervention1: Tobramycin inhalation powder: 112 mg tobramycin ( 4 capsules of 28 mg) b.i.d. administered by T-326 inhaler for 25 week. Control Intervention1: NIL: Not Applicable

Eligibility

Inclusion criteria

Inclusion criteria: 1.Completed all visits in study CTBM100C2303, and visit 4 took place not more than 5 days before enrollment into this study. 2. Confirmed diagnosis of cystic fibrosis patients with P. aeruginosa infection. 3. FEV1 at screening (study CTBM100C2303) must be between 25 percent and 80 percent of normal predicted values.

Exclusion criteria

Exclusion criteria: 1. Any use of inhaled anti-pseudomonal antibiotics between the termination of the core trial CTMB100C2303 and the enrollment into this study. 2. Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.

Design outcomes

Primary

Measure	Time frame
Safety of tobramycin inhalation powder for the treatment of infections with P. aeruginosa in subjects suffering from cystic fibrosis.Timepoint: Each visit during the 168-day treatment period	—

Secondary

Measure	Time frame
Density of microorganisms in sputum samplesTimepoint: Each visit (except last visit) during the 168-day treatment period;Efficacy of tobramycin inhalation powder, assessed by spirometryTimepoint: Each visit during the 168-day treatment period	—

Countries

Estonia, India, Russian Federation

Contacts

Public ContactMurugananthan K

murugananthan.k@novartis.com022-24958545

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026