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, can be used to treat 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.

Condition	Intervention	Phase
Cystic Fibrosis	Drug: Tobramycin Inhalation Powder	Phase III

Ages Eligible for Study:  9 Years   -   19 Years,  Genders Eligible for Study:  Both

Criteria

Main Inclusion Criteria:

• Confirmed diagnosis of cystic fibrosis.
• Male and female subjects between 6 and 19 years of age at the time of screening.
• FEV1 at screening must be between 25% and 75% of normal predicted values.

Main Exclusion Criteria:

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00125346

Wendy Verret, M.P.H      510-923-8267    wendy_verret@chiron.com

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Study ID Numbers:  TIP002
Last Updated:  August 1, 2005
Record first received:  July 29, 2005
ClinicalTrials.gov Identifier:  NCT00125346
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-02