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

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 or systemic anti-pseudomonal antibiotic within 28 days prior to study drug administration
• •Use of loop diuretics within 7 days prior to study drug administration