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S.S August 2020 PM-GB-NA-WCNT-200006

Relvar Ellipta (fluticasone furoate/vilanterol)
Relvar Ellipta (fluticasone furoate/ vilanterol) a once-daily asthma inhaler

25% more patients improved asthma control vs
other ICS/LABAs1*

In a subset analysis of an open-label RCT in >4000 patients aged ≥18, the proportion of responders at 6 months was 70% vs. 56% for the usual care arm as measured by the Asthma Control Test (ACT) - a clinically validated patient questionnaire which reflects the previous 4 weeks1.

Other ICS/LABAs commonly prescribed were Seretide (fluticasone proprionate/salmeterol) 30%, Symbicort (budesonide/formoterol) 15%, Fostair (beclomethasone/formoterol) 12%1.

In a double-blind non-inferiority RCT in c. 1500 patients vs. Seretide, the ACT score favoured Relvar but did not reach significance [0.2 (95% CI -0.1 - 0.5)] this study provides further context around other data relating to this endpoint17.

Find out how

*Data is from a pre-planned subset analysis of the patients in the Primary Efficacy Analysis (PEA) population prescribed ICS/LABA at randomisation. The primary endpoint was the proportion of patients who achieved an improvement in ACT score from baseline of ≥3 or a total ACT score of ≥20, in patients in the PEA population initiated on Relvar vs. continuing on usual care at 24 weeks. The primary endpoint was met.

What is Relvar Ellipta?

Indication

Relvar Ellipta is indicated for the regular treatment of asthma in adults and adolescents ≥12 years where use of a combination medicinal product (ICS and LABA) is appropriate2

  • Patients not adequately controlled with ICS and ‘as needed’ inhaled short-acting β2-agonists
  • Patients already adequately controlled on ICS/LABA.2

Dosing

One inhalation once-daily of Relvar 92/22 mcg for patients who require a low to mid dose of ICS in combination with a LABA.2

Relvar dose can be increased to 184/22 mcg, which may provide additional improvement in asthma control.2

Download BTS/SIGN 2019 guidance
PDF - 2.0MB
Relvar Ellipta is not indicated for the relief of acute bronchospasm.

Asthma patient profile

Sometimes I can't stop coughing when I am talking or laughing. It's embarrassing!

Amelia, 34

Asthma Control Test (ACT) score

Asthma control test (ACT) score

Current maintenance treatment:

ICS

Profile:

  • Increased wheeze and cough that are starting to impact her daily life
  • Symptoms progressing with high use of reliever
  • Stays at home to avoid symptoms, which affects her social life

Fictional patient for illustrative purpose only.

Asthma patient profile

I get chest tightness at night that makes sleep impossible. I’m often irritable the next day.

Kiran, 25

Asthma Control Test (ACT) score

Asthma control test (ACT) score

Presenting complaint

  • Nocturnal symptoms 3x a week, which keeps him awake and leaves him tired for the day
  • On ICS treatment and as needed SABA

History of presenting complaint

  • Experienced a non-infective exacerbation in the previous year
  • Diagnosed with asthma at 6 years old
  • Suffers from eczema and food allergies

On examination

  • Peak expiratory flow rate (PEFR): 500
  • No anomaly detected

Fictional patient for illustrative purpose only.

Asthma patient profile

I don’t want to take my inhaler in front of my friends. It makes me feel different.

Isabelle, 18

Asthma Control Test (ACT) score

Asthma control test (ACT) score

Presenting complaint

  • Symptoms when playing netball
  • Feels embarrassed to take her inhaler at college. Uses her twice-daily ICS/LABA once-a-day
  • 10 SABA prescriptions in the past 12 months

History of presenting complaint

  • No history of hospitalisation for an exacerbation in the previous year
  • Diagnosed with asthma at 9 years old
  • Family history of atopic disorders

On examination

  • No anomaly detected

Fictional patient for illustrative purpose only.

Efficacy for your patients – relevant, real-world results

The Salford Lung Study (SLS) was an open-label randomised control trial (RCT) that compared Relvar vs. Usual Care in over 4,000 patients aged 18 and above in everyday clinical practice. It explored 3 key patient reported outcomes, right here in the UK.1
How could Relvar benefit your asthma patients?

Effectiveness in clinical practice

icon

Relvar – studied in an RCT in everyday clinical practice

A robust, open-label, pragmatic RCT study comparing Relvar with usual care (ICS or ICS/LABA) in 4,233 patients1

RCT study comparing Relvar Ellipta (fluticasone furoate/ vilanterol) once daily asthma inhaler with (ICS or ICS/LABA)

Relvar – superior to other ICS/LABAs in helping more patients improve asthma control in everyday clinical practice1

Data is from the Salford Lung Study, an open-label RCT that compared Relvar vs. Usual Care (in over 4,000 patients) aged 18 and above.

ACT score showing Relvar Ellipta once daily asthma inhaler (fluticasone furoate/ vilanterol) superior to other ICS/LABAs in improving asthma

In a subset analysis of an open-label RCT in >4000 patients aged ≥18, the proportion of responders at 6 months was 70% vs. 56% for the usual care arm as measured by the Asthma Control Test (ACT) - a clinically validated patient questionnaire which reflects the previous 4 weeks1.

In a double-blind non-inferiority RCT in c. 1500 patients vs. Seretide, the ACT score favoured Relvar but did not reach significance [0.2 (95% CI -0.1 - 0.5)] this study provides further context around other data relating to this endpoint17.

SLS Asthma - Relvar safety profile is consistent with usual care in everyday clinical practice

Serious adverse events of special interest were consistent between Relvar and usual care (ICS or ICS/LABA) in a population reflecting everyday clinical practice.

Salford lung study (SLS) showing Relvar Ellipta once daily asthma inhaler (fluticasone furoate/ vilanterol) safety profile

*According to treatment received at the time of the event; data from the Salford Lung Study in asthma, n=4,233

Improve asthma control test

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Relvar – greater improvements across all 5 ACT components vs. other ICS/LABAs7

Relvar Ellipta once daily asthma inhaler (fluticasone furoate/ vilanterol) greater improvement across all ACT components vs other ICS LABAs

*Statistical analysis was not performed on the individual questions of the ACT. Data presented are from a pre-planned analysis from a subset of patients in the Intention To Treat (ITT) population prescribed ICS/LABA at baseline initiated with Relvar or continued on their existing ICS/LABA. Overall mean change in ACT score from baseline was 3.3 for Relvar and 1.8 for ICS/LABAs (p‹0.001).7

Relvar – achieves meaningful improvement in asthma control vs. other ICS/LABAs7

Relvar Ellipta once daily asthma inhaler (fluticasone furoate/ vilanterol) achieves greater asthma control vs other ICS LABAs

Data presented are a pre-planned analysis of the SLS study, from a subset of patients in the ITT population prescribed ICS/LABA at baseline that were either initiated with Relvar or continued on their existing ICS/LABA7

Improve quality of life

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Relvar – superior to other ICS/LABAs in helping more patients in everyday clinical practice improve their quality of life7

Relvar Ellipta – superior to other ICS/LABAs in helping more patients improve their quality of life compared to fostair and Symbicort

In a subset analysis of an open-label RCT in >4000 patients aged ≥18, the proportion of responders at 6 months was 70% vs. 56% for the usual care arm as measured by the Asthma Control Test (ACT) - a clinically validated patient questionnaire which reflects the previous 4 weeks1.

In a double-blind non-inferiority RCT in c. 1500 patients vs. Seretide, the ACT score favoured Relvar but did not reach significance [0.2 (95% CI -0.1 - 0.5)] this study provides further context around other data relating to this endpoint17.

Relvar – superior across all domains of the AQLQ vs. other ICS/LABAs7

Relvar Ellipta once daily asthma inhaler – superior across all domains of the AQLQ vs. other ICS/LABAs

*Quality of life was measured by the Asthma Quality of Life Questionnaire at 12 months. A clinically meaningful improvement is defined as an increase from baseline of ≥0.5 units12. Data presented are from a subset of patients in the ITT population prescribed ICS/LABA at baseline who were initiated with Relvar or continued on their existing ICS/LABA.
**Analysis of the environmental stimuli domain was pre-planned.
†Data presented from a post-hoc analysis.

In a subset analysis of an open-label RCT in >4000 patients aged ≥18, the proportion of responders at 6 months was 70% vs. 56% for the usual care arm as measured by the Asthma Control Test (ACT) - a clinically validated patient questionnaire which reflects the previous 4 weeks1.

In a double-blind non-inferiority RCT in c. 1500 patients vs. Seretide, the ACT score favoured Relvar but did not reach significance [0.2 (95% CI -0.1 - 0.5)] this study provides further context around other data relating to this endpoint17.

The Asthma Quality of Life Questionnaire (AQLQ) is clinically validated to assess the physical and emotional impact of asthma on patients' lives9

The Asthma Quality of Life Questionnaire (AQLQ) assesses the impact of asthma on patients' lives

In this study there was no difference in serious adverse events reported between Relvar and usual care. The most common serious adverse events of special interest were cardiovascular disease, asthma and bronchospasm, and pneumonia.

Safety profile

Relvar is generally well tolerated; the most commonly reported adverse reactions were headache and nasopharyngitis.2 View the full safety profile

Video Library

Relvar Ellipta (fluticasone furoate/ vilanterol) once daily asthma inhaler
Relvar Ellipta (fluticasone furoate/ vilanterol) once daily asthma inhaler has long duration of action

Long duration of action

High receptor binding affinity11
Low systemic exposure2,11

Relvar Ellipta (fluticasone furoate/ vilanterol) once daily asthma inhaler is 24 hour treatment

24 hours

of continuous efficacy through once daily dosing12,17

Relvar Ellipta (fluticasone furoate/ vilanterol) once daily asthma inhaler works in 15 minutes

15 minute action

Rapid bronchodilation within 15 minutes12

Ellipta, an easy-to-use inhaler that is taken once-a-day

It’s hard for us to get it right all the time. Incorrect inhaler use is common and associated with poor disease control.14

Ellipta – easy-to-use15

Relvar Ellipta (fluticasone furoate/ vilanterol) once daily asthma inhaler is easy to use

Adapted from Svedsater H et al. Prim Care Respir Med 2014; 24:14019 (n=1,050)

Ellipta – patient-preferred vs. Turbohaler, Accuhaler and MDI16

Significantly more patients demonstrated overall device preference to Ellipta vs other inhalers (Turbohaler, Accuhaler, MDI).

Relvar Ellipta (fluticasone furoate/ vilanterol) once daily asthma inhaler is patient preferred

<10% of patients had no preference
Adapted from van der Palen et al. Prim Care Respir Med 2016; 26:16079

Ellipta – 6x fewer patients make a critical error vs. Turbohaler16

Relvar Ellipta (fluticasone furoate/ vilanterol) once daily asthma inhaler has lower critical errors than turbohaler

A critical error was defined as an error that is most likely to result in no, or minimal medication being inhaled
Adapted from van der Palen et al. Prim Care Respir Med 2016; 26:16079

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Asthma patient support

Get started with Relvar for your patients

Support your knowledge of asthma

Keep up-to-date with the everchanging world of respiratory

Off Your Chest respiratory blog with key asthma information

Off your Chest

Your one-stop shop for educational respiratory content in blog form.

Webinars upcoming

Webinars upcoming

Join your peers and healthcare experts on exclusive webinars run by GSK.

Asthma expert perspectives

Asthma expert perspectives

Watch GSK Global Medical Experts approach key issues in asthma treatment.

Isn’t it time you tried Relvar in asthma?

References

  1. Woodcock et al. Effectiveness of fluticasone furoate plus vilanterol on asthma control in clinical practice: an open-label, parallel group, randomised controlled trial. Lancet 2017; 390:2247-2255.
  2. Relvar Ellipta SmPC
  3. Nathan RA, et al. Development of the asthma control test: a survey for assessing asthma control. J Allergy Clin Immunol. 2004;113:59–65;
  4. Schatz M, et al. The minimally important difference of the Asthma Control Test. J Allergy Clin Immunol. 2009;124:719–23.e1
  5. Schatz M, et al. Asthma Control Test: reliability, validity, and responsiveness in patients not previously followed by asthma specialists. J Allergy Clin Immunol. 2006; 117:549–56; 8.
  6. Herland K, et al. How representative are clinical study patients with asthma or COPD for a larger “real life” population of patients with obstructive lung disease? Respir Med 2005; 99:11-19
  7. Svedsater H, et al. Patient-reported outcomes with initiation of fluticasone furoate/ vilanterol versus continuing usual care in the asthma Salford Lung Study. Respir Med 2018;141: 198-206.
  8. GSK. Clinical Study Report. 2017; HZA115150. Last accessed May 2019 (Table 27, page 114)
  9. Juniper EF, et al. Determining a minimal important change in a disease specific quality of life questionnaire. J Clin Epidemiol 1994; 47:81-87
  1. Daley-Yates PT. Inhaled corticosteroid: potency, dose equivalence and therapeutic index. Br J Clin Pharmacol 2015.
  2. Hanania NA. The efficacy and safety of the novel long-acting β2 agonist vilanterol in patients with COPD: a randomized placebo-controlled trial. Chest 2012; 142:119-127
  3. Braithwaite I, et al. Randomised, double-blind, placebo-controlled, cross-over single dose study of the bronchodilator duration of action of combination fluticasone furoate/vilanterol inhaler in adult asthma. Respir Med 2016; 119:115-121
  4. Bardsley G, et al. Anti-inflammatory duration of action of fluticasone furoate/vilanterol trifenatate in asthma: a cross-over randomised controlled trials. Respir Res 2018; 19:133.
  5. Melani AS, et al. Inhaler mishandling remains common in real life and is associated with reduced disease control. Resp Med 2011; 105(6):930-938
  6. Svedsater H, et al. Ease of use of the ELLIPTA dry powder inhaler:data from three randomised controlled trials in patients with asthma. Prim Care Respir Med 2014; 24: 14019
  7. van der Palen J, 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. Prim Care Respir Med 2016; 26:16079.
  8. Bernstein DI et al. J Asthma. 2015; 52(10);1073-1083
  9. Woodcock A, et al. Chest 2013;144:1222–9
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Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GlaxoSmithKline on 0800 221 441.

Relvar and Ellipta are registered trademarks of the GlaxoSmithKline group of companies

M.A. Last updated: September 2020 | PM-GB-FFV-WCNT-200002