Status:
COMPLETED
Long Term Safety of Tobramycin Inhalation Powder in Patients With Cystic Fibrosis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Pulmonary Infections
Pseudomonas Aeruginosa in Cystic Fibrosis
Eligibility:
All Genders
6+ years
Phase:
PHASE4
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT01519661
Start Date
January 1 2012
End Date
January 1 2014
Last Update
February 10 2015
Active Locations (49)
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1
Novartis Investigative Site
Little Rock, Arkansas, United States, 72205
2
Novartis Investigative Site
Denver, Colorado, United States, 80206
3
Novartis Investigative Site
Jacksonville, Florida, United States, 32207
4
Novartis Investigative Site
Atlanta, Georgia, United States, 30322