Overview

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.