Levofloxacin Inhalation Solution (MP-376) in Patients with Cystic Fibrosis with Pseudomonas aeruginosa

• DOI: 10.1164/rccm.201008-1293oc
• Publication Date: 2011-02-26T05:12:07Z
• Authors: David E. Geller; Patrick A. Flume; Doris Staab; Rainald Fischer; Jeffery S. Loutit; Douglas J. Conrad
• Keywords: Clinical endpoint

Rationale: Lower respiratory tract infection with Pseudomonas aeruginosa (PA) is associated increased morbidity in patients cystic fibrosis (CF). Current treatment guidelines for inhaled antibiotics are not universally followed due to the perception of decreased efficacy, increasing resistance, drug intolerance, and high burden current aerosol antibiotics. New options CF pulmonary infections needed.Objectives: This study assessed efficacy safety a novel formulation levofloxacin (MP-376, Aeroquin) heavily treated population PA infection.Methods: randomized 151 chronic one three doses MP-376 (120 mg every day, 240 twice day) or placebo 28 days. The primary endpoint was change sputum density. Secondary endpoints included changes function, need other anti-PA antimicrobials, patient-reported symptom scores, monitoring.Measurements Main Results: All resulted reduced density at Day 28, day showing 0.96 log difference compared (P = 0.001). There dose-dependent increase FEV1 MP-376, 8.7% between group 0.003). Significant reductions (61–79%) antimicrobials were observed all groups placebo. generally well tolerated relative placebo.Conclusions: Nebulized MP-376was demonstrated significant clinical lung infection.Clinical trial registered www.clinicaltrials.gov (NCT00677365).