Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Subjects

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Trial to Assess the Efficacy and Safety of Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis (CF) Subjects

Lung infections are a chronic problem for patients with cystic fibrosis (CF). Some patients with CF may have a type of bacteria called Pseudomonas aeruginosa in their lungs that can cause infections or make their symptoms worse. Tobramycin inhalation solution (TOBI) is an approved antibiotic, which is inhaled directly into the lungs, and can be used to manage these infections. Tobramycin inhalation powder (TIP) is a new, experimental powder formulation of tobramycin that is inhaled directly into the lungs using a T-326 inhaler. The purpose of this research study is to determine if TIP is safe and effective when compared to placebo (a powder with no medicine) treatment.

Inclusion Criteria:

• Confirmed diagnosis of cystic fibrosis patients with Pseudomonas aeruginosa infection.
• Male and female subjects between 6 and 21 years of age at the time of screening.
• FEV1 at screening must be between 25% and 80% of normal predicted values.

Exclusion Criteria:

• Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.