Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Amgen
This trial will be a double-blind, placebo-controlled study to evaluate the safety, tolerability and efficacy of levofloxacin administered as MP-376 of three dosage regimens given for 28 days by the aerosol route to CF patients.
Study with completed results acquired from Horizon in 2024.
Age
16–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
\> 16 years of age
Confirmed Diagnosis of Cystic Fibrosis
Positive sputum culture for P. aeruginosa within the past 18 months
Patients are able to elicit a forced expiratory volume in 1 second (FEV1) \>/= 25% but \</= 85% of predicted value at screening
Have received at least 3 courses of inhaled antimicrobials over the preceding 12 months
Clinically stable with no changes in health status within the last 30 days
Able to reproducibly produce sputum and perform spirometry
You may not be if
Use of any nebulized or systemic antibiotics within 30 days prior to baseline
History of hypersensitivity to fluoroquinolones or intolerance with aerosol medication
Evidence of acute upper within 10 days or lower respiratory infections within 30 days prior to dosing
Creatine clearance \< 50mg/ml, aspartate transaminase (AST), alanine transaminase (ALT) or total bilirubin \>/= 3 x upper limit of normal (ULN) at Screening
Clareo Health | Safety, Tolerability and Efficacy of MP-376 Given for 28 Days to Cystic Fibrosis (CF) Patients
