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Keep this study
Lead
Amgen
This study will be a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and efficacy of MP-376 inhalation solution given daily for 5 days in a 28 day treatment cycle to COPD patients.
Study with completed results acquired from Horizon in 2024.
Age
40–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
\> 40 years of age
History of COPD
Forced expiratory volume in 1 second (FEV1) \</= 70% of predicted and FEV1/Forced vital capacity (FVC) \</= 0.7 value at screening
Have at least two acute exacerbation episodes in the proceeding year
Clinically stable with no changes in health status within the last 30 days
Lifetime smoking history of at least 10 pack-years
Willing and able to use a daily electronic diary
You may not be if
Use of any systemic or inhaled antibiotics within 30 days prior to baseline
History of hypersensitivity to fluoroquinolones or intolerance with aerosol medication
Creatinine clearance \< 40 mg/ml/min, AST, ALT \>/= 5 x upper limit of normal (ULN) or total bilirubin \>/= 3 x ULN at Screening
Clareo Health | A Phase 2 Study of MP-376 to Prevent Acute Exacerbations in Chronic Obstructive Pulmonary Disease (COPD) Patients
