title: Safety and efficacy of prolonged levofloxacin inhalation solution (APT-1026) treatment for cystic fibrosis and chronic Pseudomonas aeruginosa airway infection.
abstract: Levofloxacin inhalation solution (LIS) is the first aerosolized fluoroquinolone licensed for treatment of patients with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa lung infection. This study evaluated the safety and efficacy of extended LIS treatment.
  
  
  
  Patients completing a multinational, randomized study comparing LIS and tobramycin inhalation solution (TIS) were enrolled in an open-label extension in which all patients received three additional cycles of 28days of LIS 240mg twice daily followed by 28days off drug. Endpoints included mean relative change in percent predicted forced expiratory volume in 1s (FEV1), time to pulmonary exacerbation, and patient-reported quality of life.
  
  
  
  Extended treatment with LIS in 88 patients was well tolerated with no new safety signals and evidence of positive effects on FEV1 and quality of life.
  
  
  
  Patients receiving extended LIS treatment continued to show favorable efficacy with no additional safety concerns.
authors.affiliation: Centre for Infection and Immunity, School of Medicine, Dentistry and Biomedical Sciences, University Belfast, 97 Lisburn Road, Belfast BT9 7AE, UK. Electronic address: s.elborn@qub.ac.uk.
authors.forename: J Stuart
authors.initials: JS
authors.lastname: Elborn
authors.affiliation: Department of Medicine, Medical University of South Carolina, Charleston, SC, USA; Department of Pediatrics, Medical University of South Carolina, Charleston, SC, USA. Electronic address: flumepa@musc.edu.
authors.forename: Patrick A
authors.initials: PA
authors.lastname: Flume
authors.affiliation: Future Therapies, LLC, Washington Crossing, PA, USA. Electronic address: fred@future-therapies.com.
authors.forename: Fredric
authors.initials: F
authors.lastname: Cohen
authors.affiliation: The Medicines Company, San Diego, CA, USA. Electronic address: jeff.loutit@THEMEDCO.com.
authors.forename: Jeffery
authors.initials: J
authors.lastname: Loutit
authors.affiliation: Department of Pediatrics, Case Western Reserve University School of Medicine, Cleveland, OH, USA. Electronic address: dutch.vandevanter@gmail.com.
authors.forename: Donald R
authors.initials: DR
authors.lastname: VanDevanter
mesh_terms: D000280:Administration, Inhalation; D000328:Adult; D000336:Aerosols; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects; D003550:Cystic Fibrosis / Q000175:diagnosis / Q000188:drug therapy / Q000382:microbiology; D004305:Dose-Response Relationship, Drug; D016903:Drug Monitoring / Q000379:methods; D005260:Female; D006801:Humans; D064704:Levofloxacin / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D011552:Pseudomonas Infections / Q000175:diagnosis / Q000188:drug therapy; D011550:Pseudomonas aeruginosa / Q000187:drug effects / Q000302:isolation & purification; D012141:Respiratory Tract Infections / Q000175:diagnosis / Q000188:drug therapy / Q000382:microbiology; D014031:Tobramycin / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000336:Aerosols; D000900:Anti-Bacterial Agents; D064704:Levofloxacin; D014031:Tobramycin
keywords: Antibiotics; Cystic fibrosis; Fluoroquinolone; Inhalation solution; Levofloxacin; Pseudomonas