Open Label Extension to Bridging Study CTBM100C2303

Novartis

Status and phase: Completed; Phase 3

Conditions: Cystic Fibrosis; Pseudomonas Aeruginosa

Treatments: Drug: Tobramycin inhalation powder

Study type: Interventional

Funder types: Industry

Identifiers

NCT00982930

CTBM100C2303E1

2008-004764-39 (EudraCT Number)

Details and patient eligibility

About

This was an open-label, single arm (uncontrolled) study in participants suffering from cystic fibrosis, who had completed their study participation in CTBM100C2303 (all visits) and who were proven infected with Pseudomonas aeruginosa (P. aeruginosa) at enrollment into CTBM100C2303.

Enrollment: 55 patients

Sex: All

Ages: 6 to 21 years old

Volunteers: No Healthy Volunteers

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 participants with P. aeruginosa infection.
• Forced Expiratory Volume in One Second (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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

Tobramycin Inhalation Powder (TIP)

Experimental group

Description:

Participants received 112 mg (four 28 mg capsules) of TIP administered by the T-326 Inhaler, twice a day (b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment (one cycle = 56 days) for up to 3 cycles.

Treatment:

Drug: Tobramycin inhalation powder