INTENDED FOR UK & IRELAND HEALTHCARE PROFESSIONALS

INTENDED FOR UK & IRELAND HEALTHCARE PROFESSIONALS

PRESCRIBING INFORMATION

Overview of Quinsair® (levofloxacin hemihydrate) key studies

Quinsair is licensed in adults 18 years old and over.
Select a key study below to learn more about its design, endpoints and results.

  • MPEX 207, Flume PA, et al ¹

  • MPEX 209, Elborn JS, et al ²

  • MPEX 209 (Ext.), Elborn JS, et al ³

Study aim: to investigate the efficacy and safety of Quinsair in patients aged 12 years and above with cystic fibrosis (Note: Quinsair is indicated in adults aged 18 years and over)

Study design: Phase III, randomised 2:1, double-blind, placebo-controlled study. Populations: Quinsair n=220 vs. placebo n =110

Primary endpoint: time to exacerbation in patients with cystic fibrosis

Secondary endpoints: absolute change in FEV1% predicted, patient-reported quality of life, change in Pseudomonas aeruginosa density from baseline

TIME TO EXACERBATION QUINSAIR VS. PLACEBO

Quinsair is licensed in adults 18 years old and over.

ABSOLUTE CHANGE IN FEV1% PREDICTED FROM BASELINE TO DAY 28

Adapted from: Flume PA et al. 20161

1.31% improvement in FEV1% predicted (LS mean difference 95% CI:0.27, 2.34; p=0.0137)1

Quinsair is licensed in adults 18 years old and over.

STUDY OVERVIEW

FEV1, forced expiratory volume in 1 second; LS, Least squares; SE, standard error; PBO, placebo

Study aim: to evaluate the efficacy and safety of Quinsair compared with tobramycin inhaled solution (TIS) over three treatment cycles in stable cystic fibrosis patients ≥ 12 years (Note: Quinsair is indicated in adults aged 18 years old and over)

Study design: Phase III, non-inferiority, randomised, multi-national, open-label, active comparator

Primary endpoint: relative change in FEV1 % predicted from baseline to Day 28

Secondary endpoints: time to exacerbation, time to additional anti-pseudomonal antibiotic use and patient-reported quality of life

MEAN CHANGES FROM BASELINE IN FEV1% PREDICTED OVER 3X 28-DAY ON-TREATMENT, 28-DAY OFF-TREATMENT CYCLES

Quinsair is licensed in adults 18 years old and over.

FEV1, forced expiratory volume in 1 second; LS, Least squares

QUINSAIR INCREASED THE TIME TO FIRST EXACERBATION VS. TIS (SECONDARY ENDPOINT)

Quinsair is licensed in adults 18 years old and over.

TIS, tobramycin inhaled solution

QUINSAIR SIGNIFICANTLY REDUCED EXACERBATION-RELATED HOSPITALISATIONS VS. TIS

Quinsair is licensed in adults 18 years old and over.

TIS, tobramycin inhaled solution

STUDY OVERVIEW

FEV1, forced expiratory volume in 1 second; SAE, serious adverse event; TIS, tobramycin inhaled solution

Study aim: to evaluate the efficacy and safety of prolonged Quinsair treatment

Study design: open-label, non-randomised, single-arm extension study. Patients in the tobramycin inhaled solution (TIS) group who continued the trial were switched to Quinsair (LIS)

Primary endpoint: relative change in FEV1% predicted from baseline to Day 28

Secondary endpoints: time to exacerbation, time to additional anti-pseudomonal antibiotic use and patient-reported quality of life

CHANGE IN FEV1% PREDICTED VS. RCT

Quinsair is licensed in adults 18 years old and over.

LS, least squares; FEV1, Forced expiratory volume in 1 second; RCT,  randomised controlled trial; SE, standard error

MEDIAN TIME TO FIRST EXACERBATION

Quinsair is licensed in adults 18 years old and over.

RCT, randomised controlled study

CHANGE IN CFQ-R

Quinsair is licensed in adults 18 years old and over.

CFQ-R, cystic fibrosis questionnaire-revised; SE, standard error

STUDY OVERVIEW

CFQ-R, cystic fibrosis questionnaire-revised; FEV1, forced expiratory volume in 1 second; SAE, serious adverse event; RCT, randomised controlled trial; TIS, tobramycin inhaled solution


1. Flume PA, et al. J Cyst Fibros. 2016;15:495-502.
2. Elborn JS, et al. J Cyst Fibros. 2015;14:507-14.
3. Elborn JS, et al. J Cyst Fibros. 2016; 15: 634-40.