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

J Cyst Fibros. 2015 Jul;14(4):507-14. doi: 10.1016/j.jcf.2014.12.013. Epub 2015 Jan 13.


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.

Trial registration: ClinicalTrials.gov NCT02109822.

Keywords: Aerosol; Antibiotics; Cystic fibrosis; Fluoroquinolone; Pseudomonas.

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Inhalation
  • Adolescent
  • Adult
  • Anti-Bacterial Agents / administration & dosage*
  • Chronic Disease
  • Cystic Fibrosis / drug therapy*
  • Cystic Fibrosis / microbiology
  • Female
  • Forced Expiratory Volume
  • Humans
  • Levofloxacin / administration & dosage*
  • Male
  • Pseudomonas Infections / complications
  • Pseudomonas Infections / drug therapy*
  • Pseudomonas aeruginosa*
  • Quality of Life
  • Tobramycin / administration & dosage*
  • Treatment Outcome
  • Young Adult


  • Anti-Bacterial Agents
  • Levofloxacin
  • Tobramycin

Associated data

  • ClinicalTrials.gov/NCT02109822