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MLT_GIB/OTH/0007/17m
Date of preparation: March 2018

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Relvar Ellipta overview

(fluticasone furoate and vilanterol inhalation powder)

Asthma: Relvar Ellipta is indicated for regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate: patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short acting beta2-agonists and patients already adequately controlled on both inhaled corticosteroid and long-acting beta2-agonist.1

COPD: Relvar Ellipta is indicated for the symptomatic treatment of adults with COPD with a FEV1<70% predicted normal (post-bronchodilator) with an exacerbation history despite regular bronchodilator therapy. 1

 

 

Relvar is the only ICS/LABA combination indicated for asthma and COPD that delivers 24 hours of continuous efficacy from just one daily dose 23

 

Relvar is available in the Ellipta – an easy-to-use inhaler that helps patients receive the benefit of their medication 4

How does Relvar Ellipta work?

Relvar contains fluticasone furoate, an inhaled corticosteroid (ICS) and highly effective anti-inflammatory agent, and vilanterol, a selective long-acting β2 receptor agonist (LABA) with bronchodilator activity 1

 

Click play to see how Relvar’s FF and VI combination is able to deliver 24 hours of continuous efficacy

Video player requires JavaScript enabled. You can download this video here: http://edgesuite.gskstatic.com/HealthSites/Health/HCP_Portal/master/relvar/Hive_MOA_01.mp4

In vitro data – the clinical significance of these findings is unknown. Fluticasone furoate monotherapy is not licensed in Europe for asthma, or for use in COPD. Vilanterol monotherapy is not licensed for use in asthma or COPD.

The Relvar Ellipta device.

Click on the image to find out more about the Ellipta – an easy-to-use device which helps patients receive the benefit of their medication. 4

Relvar Ellipta for asthma

Relvar can help provide:

13 additional symptom-free hours per week vs ICS alone 2*
*Treatment difference 7.8%; 95%CI: 2.9%, 12.6%; p=0.002 
5


A 25% reduction in annual rate of severe exacerbations vs ICS alone 6**
**Rate 0.14 vs 0.19 per year, respectively; rate reduction 95%CI: 5%, 40%; p=0.014 
6

Additional symptom-free nights per week vs. baseline in post hoc analyses 7

Meaningful improvements in quality of life (with a once-daily dose, versus Seretide twice-daily) 8-11
‡In a post hoc analysis (46% vs 38% respectively, p=0.023) 
8-11

Relvar Ellipta for COPD

For your patients with COPD, Relvar can help with:

Improvements in lung function sustained over an entire year 12 *

Pooled analysis. 

 

Significantly fewer moderate/severe exacerbations (8.4%; p=0.02) vs. twice-daily ICS/LABA 13

Reduced impact of COPD symptoms† compared with usual care 13

†As measured by the COPD Health Assessment (CAT) Test, a self completion questionnaire comprising eight questions covering domains relating to the impact of COPD symptoms such as cough, chest tightness, breathlessness, sleep and energy1315
‡See below for the defition of usual care in the SLS13

What is usual care in the SLS?

In the Relvar SLS COPD study, usual care was a physician-determined COPD maintenance treatment in accordance with usual clinical practice. Of all ITT patients with ≥1 moderate/severe exacerbation in the year prior to randomisation (n=2,269) at baseline13

  •  88% were on an ICS-containing regimen
  •  54% were on triple therapy (ICS/LABA + LAMA)
  •  12% were on a bronchodilation therapy only (LAMA, LABA or LAMA + LABA)

References

  1. Relvar  Summary of Product Characteristics, GlaxoSmithKline. 
  2. Bernstein DI et al. Fluticasone furoate (FF)/vilanterol (100/25 mcg or 200/25 mcg) or FF (100mcg) in persistent asthma. J Asthma. 2015; 52(10): 1073– 1083.
  3. Boscia JA et al. Effect of once-daily fluticasone furoate/vilanterol on 24-hour pulmonary function in patients with chronic obstructive pulmonary disease: a randomized, three-way, incomplete block, crossover study. Clin Ther. 2012;34(8): 1655–1666.e5.
  4. van der Palen et al. A randomised open-label cross-over study of inhaler errors, preference and time to achieve correct inhaler use in patients with COPD or asthma: comparison of Ellipta with other inhaler devices. Primary Care Resp Med 2016;26: 16079; doi:10.1038/npjpcrm.2016.79.
  5. Bernstein DI et al. Fluticasone furoate (FF)/vilanterol (100/25 mcg or 200/25 mcg) or FF (100 mcg) in persistent asthma. J Asthma. 2015; Online supplement: Table S3.
  6. Bateman ED et al., Once-daily fluticasone furoate (FF)/vilanterol reduces risk of severe exacerbations in asthma versus FF alone. Thorax. 2014; 69: 312– 319.
  7. Leather DA et al. Fluticasone furoate (FF)/vilanterol (VI) once daily reduces asthma symptoms both day and night. British Thoracic Society, London, UK, 02-04 December 2015; Poster 152.
  8. Woodcock A et al. Efficacy and safety of fluticasone furoate/vilanterol compared with fluticasone propionate/salmeterol combination in adult and adolescent patients with persistent asthma: a randomized trial. Chest. 2013; 144(4): 1222–1229.
  9. Woodcock A et al. Efficacy and safety of fluticasone furoate/vilanterol compared with fluticasone propionate/salmeterol combination in adult and adolescent patients with persistent asthma: a randomized trial. Chest. 2013; Online supplement: 1–7.
  10. Juniper EF et al. Determining a minimal important change in a disease- specific quality of life questionnaire. J Clin Epidemiol. 1994; 47(1): 81–87.
  11. GSK. Data on file 113091. 2014; RECE/FFT/0148/14.
  12. Dransfield MT et al. Once-daily inhaled fluticasone furoate and vilanterol versus vilanterol only for prevention of exacerbations of COPD: two replicate double-blind, parallel-group, randomised controlled trials. Lancet Resp Med. 2013; 1(3): 210–223.
  13. Vestbo J et al. Effectiveness of Fluticasone Furoate-Vilanterol in COPD in Clinical Practice. NEJM 2016. DOI: 10.1056/NEJMoa1608033.
  14. Vestbo J et al. Effectiveness of Fluticasone Furoate-Vilanterol for COPD in Clinical Practice. NEJM 2016. DOI: 10.1056/NEJMoa1608033: Supplement 1–13.
  15. COPD Assessment Test (CAT). http://catestonline.org/images/pdfs/CATest.pdf (Last accessed: September 2016.

Relvar and Ellipta are registered trademarks of the GlaxoSmithKline Group of Companies