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

Completed · Phase 4

Conditions studied: Pulmonary Infections, Pseudomonas Aeruginosa in Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT01519661

Run by

Novartis Pharmaceuticals

People needed

157

Starts

2012-01-01

Expected to finish

2014-01-01

Last updated by the study team

2015-02-10

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Novartis Investigative Site — Little Rock, Arkansas, United States
• Novartis Investigative Site — Denver, Colorado, United States
• Novartis Investigative Site — Jacksonville, Florida, United States
• Novartis Investigative Site — Atlanta, Georgia, United States
• Novartis Investigative Site — St Louis, Missouri, United States
• Novartis Investigative Site — Omaha, Nebraska, United States
• Novartis Investigative Site — Las Vegas, Nevada, United States
• Novartis Investigative Site — Morristown, New Jersey, United States
• Novartis Investigative Site — Akron, Ohio, United States
• Novartis Investigative Site — Cleveland, Ohio, United States
• Novartis Investigative Site — Oklahoma City, Oklahoma, United States
• Novartis Investigative Site — Oklahoma City, Oklahoma, United States
• Novartis Investigative Site — Charleston, South Carolina, United States
• Novartis Investigative Site — Dallas, Texas, United States
• Novartis Investigative Site — Fort Worth, Texas, United States
• Novartis Investigative Site — Houston, Texas, United States
• Novartis Investigative Site — San Antonio, Texas, United States
• Novartis Investigative Site — Tacoma, Washington, United States
• Novartis Investigative Site — Madison, Wisconsin, United States
• Novartis Investigative Site — Milwaukee, Wisconsin, United States
• Novartis Investigative Site — Caba, Buenos Aires, Argentina
• Novartis Investigative Site — Capital Federal, Buenos Aires, Argentina
• Novartis Investigative Site — Córdoba, Córdoba Province, Argentina
• Novartis Investigative Site — Paraná, Entre Ríos Province, Argentina
• Novartis Investigative Site — New Lambton Heights, New South Wales, Australia

Full record on ClinicalTrials.gov

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