Assess the Long Term Safety of Tobramycin Inhalation Powder in Patients With Cystic Fibrosis

Inclusion Criteria:

- Confirmed diagnosis of Cystic Fibrosis

- FEV1 at screening must be between 25 and 75 percent of normal predicted values for
age, sex and height based on the Knudson equation

- Pseudomonas aeruginosa must be present in a sputum / deep cough throat swab culture
or bronchoalveolar lavage within 6 months prior to screening and in the
sputum/deep-throat cough swab culture at screening

Exclusion Criteria:

- History of sputum culture or deep cough throat swab culture yielding Burkholderia
cenocepacia complex within 2 years prior to screening and /or sputum culture yielding
Burkholderia cenocepacia at screening

- Hemoptysis more than 60mL at any time within 30 days prior to study drug
administration

- History of hearing loss or chronic tinnitus deemed clinically significant

- Serum creatinine 2mg/dl or more, BUN 40mg/dl or more, or an abnormal urinalysis
defined as 2+ or greater proteinuria at screening

- Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics

- Patients who are regularly receiving more than 1 class of inhaled anti-pseudomonal
antibiotic

- Any use of inhaled anti-pseudomonal antibiotic are not allowed

- Use of loop diuretics within 7 days prior to study drug administration

Other protocol-defined inclusion/exclusion criteria may apply.