Second Open Label Extension to Bridging Study CTBM100C2303

Novartis

Status and phase: Completed; Phase 3

Conditions: Pulmonary Infections; Pseudomonas Aeruginosa

Treatments: Drug: Tobramycin inhalation powder

Study type: Interventional

Funder types: Industry

Identifiers

NCT01069705

CTBM100C2303E2

Details and patient eligibility

About

This was an open-label, single arm (uncontrolled) study in participants 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.

Enrollment: 49 patients

Sex: All

Ages: 6 to 21 years old

Volunteers: No Healthy Volunteers

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 participants with P. aeruginosa infection.
• Forced Expiratory Volume in one second (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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 1 patient group

Tobramycin Inhalation Powder (TIPnew)

Experimental group

Description:

Participants received four capsules of 28 mg TIPnew (112 mg), inhaled twice a day (b.i.d.) in the morning and the evening given in a cycle of 28 days on treatment followed by 28 days off treatment for three consecutive cycles.

Treatment:

Drug: Tobramycin inhalation powder