Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Amgen
With
Forest Laboratories
This trial will be a double-blind, placebo-controlled study to evaluate the efficacy and safety of levofloxacin administered as MP-376 given for 28 days by the aerosol route to CF patients.
Study with completed results acquired from Horizon in 2024.
Age
12–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
\>/= 12 years of age
Confirmed Diagnosis of Cystic Fibrosis
Positive sputum culture for P. aeruginosa at screening and within the past 12 months
Patients are able to elicit an 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 28 days
Able to reproducibly produce sputum and perform spirometry
You may not be if
Use of any nebulized or systemic antibiotics within 28 days prior to baseline
History of hypersensitivity to fluoroquinolones or intolerance with aerosol medication
Evidence of respiratory infections within 14 days prior to dosing
CrCl \< 20ml/min or \< 20ml/min/1.73 m2 at Screening
Clareo Health | MP-376 (Aeroquin™, Levofloxacin for Inhalation) in Patients With Cystic Fibrosis
