Safety and efficacy of prolonged levofloxacin inhalation solution (APT-1026) treatment for cystic fibrosis and chronic Pseudomonas aeruginosa airway infection

J Stuart Elborn; Patrick A Flume; Fredric Cohen; Jeffery Loutit; Donald R VanDevanter

doi:10.1016/j.jcf.2016.01.005

Safety and efficacy of prolonged levofloxacin inhalation solution (APT-1026) treatment for cystic fibrosis and chronic Pseudomonas aeruginosa airway infection

J Cyst Fibros. 2016 Sep;15(5):634-40. doi: 10.1016/j.jcf.2016.01.005. Epub 2016 Feb 28.

Authors

J Stuart Elborn¹, Patrick A Flume², Fredric Cohen³, Jeffery Loutit⁴, Donald R VanDevanter⁵

Affiliations

¹ Centre for Infection and Immunity, School of Medicine, Dentistry and Biomedical Sciences, University Belfast, 97 Lisburn Road, Belfast BT9 7AE, UK. Electronic address: [email protected].
² Department of Medicine, Medical University of South Carolina, Charleston, SC, USA; Department of Pediatrics, Medical University of South Carolina, Charleston, SC, USA. Electronic address: [email protected].
³ Future Therapies, LLC, Washington Crossing, PA, USA. Electronic address: [email protected].
⁴ The Medicines Company, San Diego, CA, USA. Electronic address: [email protected].
⁵ Department of Pediatrics, Case Western Reserve University School of Medicine, Cleveland, OH, USA. Electronic address: [email protected].

PMID: 26935334
DOI: 10.1016/j.jcf.2016.01.005

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusion: Patients receiving extended LIS treatment continued to show favorable efficacy with no additional safety concerns.

Trial registration: ClinicalTrials.gov NCT01270347.

Keywords: Antibiotics; Cystic fibrosis; Fluoroquinolone; Inhalation solution; Levofloxacin; Pseudomonas.

Publication types

Randomized Controlled Trial

MeSH terms

Administration, Inhalation
Adult
Aerosols
Anti-Bacterial Agents / administration & dosage
Anti-Bacterial Agents / adverse effects
Cystic Fibrosis* / diagnosis
Cystic Fibrosis* / drug therapy
Cystic Fibrosis* / microbiology
Dose-Response Relationship, Drug
Drug Monitoring / methods
Female
Humans
Levofloxacin* / administration & dosage
Levofloxacin* / adverse effects
Male
Pseudomonas Infections* / diagnosis
Pseudomonas Infections* / drug therapy
Pseudomonas aeruginosa / drug effects
Pseudomonas aeruginosa / isolation & purification
Respiratory Tract Infections* / diagnosis
Respiratory Tract Infections* / drug therapy
Respiratory Tract Infections* / microbiology
Tobramycin / administration & dosage
Tobramycin / adverse effects
Treatment Outcome

Substances

Aerosols
Anti-Bacterial Agents
Levofloxacin
Tobramycin

Associated data

ClinicalTrials.gov/NCT01270347