CFDB - Cystic Fibrosis DataBase

  1. Home
  2. Database
Search (?)
at least one term
all terms
Advanced search
primary studies published RCT

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

  • Year: 2015
  • Date: 2015
  • Author: Elborn JS
Source

J Cyst Fibros. 2015 Jan 12.

Study design (if review, criteria of inclusion for studies)

multinational, randomized (2:1), non-inferiority study

Participants

CF patients ≥12years old with chronic P. aeruginosa infection.

Interventions

APT-1026 (levofloxacin inhalation solution, LIS) vs tobramycin inhalation solution (TIS) over three 28-day on/off cycles.

Outcome measures

Day 28 FEV1 % predicted relative change was the primary endpoint. Time to exacerbation and patient-reported quality of life were among secondary endpoints.

Main results

Baseline demographics for 282 subjects were comparable. Non-inferiority was demonstrated (1.86% predicted mean FEV1 difference [95% CI -0.66 to 4.39%]). LIS was well-tolerated, with dysgeusia (taste distortion) as the most frequent adverse event.

Authors' conclusions

LIS is a safe and effective therapy for the management of CF patients with chronic P. aeruginosa infection.

Related topics

Antibiotic treatment of early pseudomonas aeruginosa

Antibiotics for pulmonary exacerbations

Inhaled antibiotics in cystic fibrosis

Scheduled antibiotics every 3-4 months / symptom-based treatment

Keywords: Adult; aeroquin; Aged; Anti-Bacterial Agents; Child; Inhalation OR nebulised; levofloxacin; pharmacological_intervention; Tobramycin; Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Infection; Quinolones; Aminoglycosides; Pseudomonas aeruginosa; Pseudomonas;