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Cystic Fibrosis in Focus

ReachMD

4 episodes

5 months ago

Cystic fibrosis (CF) is one of the most prevalent global congenital disorders, affecting some 70,000 individuals worldwide and 30,000 children and adults in the United States. While clinical efforts are expanding worldwide to improve diagnostic testing and treatment approaches for this progressive lung disease, targeted therapies for CF against any specific mutation remain elusive. The Cystic Fibrosis in Focus series gathers the latest information from leading medical experts devoted to advancing knowledge in pursuit of treating patients with CF. With education spanning topics such as pinpointing CF's underlying genetic basis, identifying specific mutations, improving clinical detection methods, and providing more targeted therapies, The Cystic Fibrosis in Focus series delivers the critical tools needed to improve care for CF patients. In Partnership with

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Journal of Cystic Fibrosis: Efficacy and Safety of Levofloxacin Inhalation Solution (APT-1026) in Stable Cystic Fibrosis Patients

Cystic Fibrosis in Focus

9 years ago

Journal of Cystic Fibrosis: Efficacy and Safety of Levofloxacin Inhalation Solution (APT-1026) in Stable Cystic Fibrosis Patients

A phase 3, multi-center, multinational, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of levofloxacin inhalation solution (APT-1026) in stable cystic fibrosis patients.

Flume PA, VanDevanter DR, Morgan EE, Dudley MN, Loutit JS, Bell SC, Kerem E, Fischer R, Smyth AR, Aaron SD, Conrad D, Geller DE,Elborn JS.

J Cyst Fibros. 2016 Jul;15(4):495-502. doi: 10.1016/j.jcf.2015.12.004. Epub 2016 Feb 4.

Abstract

RATIONALE:

For patients with cystic fibrosis (CF), the use of inhaled antibiotics has become standard of care to suppress chronic Pseudomonas airways infection. There are limited antibiotic options formulated and approved for inhaled use and antibiotic efficacies attenuate over time, making additional inhaled antibiotic classes desirable. APT-1026 (levofloxacin inhalation solution, LIS) is a fluoroquinolone in development for management of chronic P. aeruginosa airways infection in patients with CF.

OBJECTIVES:

To compare the safety and efficacy of a 28-day course of treatment with LIS 240mg or placebo BID in persons ≥12years old with CF and chronic P. aeruginosa infection.

METHODS:

A multinational, randomized (2:1), double-blinded study of LIS and placebo over 28days in CF patients ≥12years with chronic P. aeruginosa infection. Time to exacerbation was the primary endpoint. FEV1 (% predicted) and patient-reported …