Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
6–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | Long Term Safety of Tobramycin Inhalation Powder in Patients With Cystic Fibrosis
