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

A Single Arm, Open-label, Multicenter, Phase IV Trial to Assess Long Term Safety of Tobramycin Inhalation Powder (TIP) in Patients With Cystic Fibrosis

This study assessed the long term safety data for the use of tobramycin inhalation powder in patients suffering from cystic fibrosis who have a chronic pulmonary infection with Pseudomonas aeruginosa.

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 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

Other protocol-defined inclusion/exclusion criteria may apply.