title: A phase 3, open-label, randomized trial to evaluate the safety and efficacy of levofloxacin inhalation solution (APT-1026) versus tobramycin inhalation solution in stable cystic fibrosis patients.
abstract: BACKGROUND
  Inhaled antibiotics are standard of care for persons with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa airway infection. APT-1026 (levofloxacin inhalation solution, LIS) is fluoroquinolone in development. We compared the safety and efficacy of LIS to tobramycin inhalation solution (TIS) in persons ≥12 years old with CF and chronic P. aeruginosa infection.
  
  
  METHODS
  This multinational, randomized (2:1), non-inferiority study compared LIS and TIS over three 28-day on/off cycles. Day 28 FEV(1) % predicted relative change was the primary endpoint. Time to exacerbation and patient-reported quality of life were among secondary endpoints.
  
  
  RESULTS
  Baseline demographics for 282 subjects were comparable. Non-inferiority was demonstrated (1.86% predicted mean FEV(1) difference [95% CI -0.66 to 4.39%]). LIS was well-tolerated, with dysgeusia (taste distortion) as the most frequent adverse event.
  
  
  CONCLUSIONS
  LIS is a safe and effective therapy for the management of CF patients with chronic P. aeruginosa infection.
authors.affiliation: Centre for Infection and Immunity, Queen's University Belfast, BT9, UK.
authors.forename: J
authors.initials: J
authors.lastname: Stuart Elborn
authors.affiliation: Florida State University College of Medicine, Orlando, FL, United States.
authors.forename: David E
authors.initials: DE
authors.lastname: Geller
authors.affiliation: Department of Medicine, University of California, San Diego, United States.
authors.forename: Douglas
authors.initials: D
authors.lastname: Conrad
authors.affiliation: The Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada.
authors.forename: Shawn D
authors.initials: SD
authors.lastname: Aaron
authors.affiliation: Division of Child Health, Obstetrics & Gynaecology, School of Medicine, University of Nottingham, UK.
authors.forename: Alan R
authors.initials: AR
authors.lastname: Smyth
authors.affiliation: Pneumologische Praxis München-Pasing, Munich, Germany.
authors.forename: Rainald
authors.initials: R
authors.lastname: Fischer
authors.affiliation: Department of Pediatrics, Hadassah Medical Center, Jerusalem, Israel.
authors.forename: Eitan
authors.initials: E
authors.lastname: Kerem
authors.affiliation: The Prince Charles Hospital, Queensland, Australia; Queensland Children's Medical Research Institute, Queensland, Australia.
authors.forename: Scott C
authors.initials: SC
authors.lastname: Bell
authors.affiliation: The Medicines Company, San Diego, CA, United States.
authors.forename: Jeffery S
authors.initials: JS
authors.lastname: Loutit
authors.affiliation: The Medicines Company, San Diego, CA, United States.
authors.forename: Michael N
authors.initials: MN
authors.lastname: Dudley
authors.affiliation: The Medicines Company, San Diego, CA, United States.
authors.forename: Elizabeth E
authors.initials: EE
authors.lastname: Morgan
authors.affiliation: Department of Pediatrics, Case Western Reserve University School of Medicine, Cleveland, OH, United States.
authors.forename: Donald R
authors.initials: DR
authors.lastname: VanDevanter
authors.affiliation: Department of Medicine, Medical University of South Carolina, Charleston, SC, United States; Department of Pediatrics, Medical University of South Carolina, Charleston, SC, United States. Electronic address: flumepa@musc.edu.
authors.forename: Patrick A
authors.initials: PA
authors.lastname: Flume
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D002908:Chronic Disease; D003550:Cystic Fibrosis / Q000188:drug therapy* / Q000382:microbiology; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D064704:Levofloxacin / Q000008:administration & dosage*; D008297:Male; D011552:Pseudomonas Infections / Q000150:complications / Q000188:drug therapy*; D011550:Pseudomonas aeruginosa; D011788:Quality of Life; D014031:Tobramycin / Q000008:administration & dosage*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D064704:Levofloxacin; D014031:Tobramycin
keywords: Aerosol; Antibiotics; Cystic fibrosis; Fluoroquinolone; Pseudomonas