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

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Tobramycin

Criteria

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.