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M.C. Last updated: March 2018. UK/COM/0106/15(2)

M.C. Last updated: March 2018. UK/COM/0106/15(2)

Relvar Ellipta▼ (fluticasone furoate/vilanterol) packshots

Relvar Ellipta▼ (fluticasone furoate/vilanterol)

Isn’t it time you tried Relvar in asthma?

What is Relvar?

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 appropriate:6

  • Patients not adequately controlled with ICS and ‘as needed’ inhaled short-acting β2-agonists
  • Patients already adequately controlled on ICS/LABA.6

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.6

Relvar dose can be increased to 184/22 mcg, which may provide additional improvement in asthma control.6

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

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

Efficacy for your patients – relevant, real-world results

The Salford Lung Study (SLS) is the world's first pragmatic randomised controlled trial (RCT) in asthma. It explored 3 key patient reported outcomes, right here in the UK.1
How could Relvar benefit your asthma patients?

Effectiveness in clinical practice

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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

Graph

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

Proportion of patients with improvement from baseline of ≥3 or achieiving a total ACT score of ≥20 in patients initiating Relvar vs. continuing on usual care (as prescribed by GP) at Month 6 in the Primary Effectiveness Analysis (PEA) population.

Graph

Data presented are from a subset of patients in the PEA population prescribed ICS/LABA at randomisation. The primary endpoint was met1. Treatment modifications were allowed. Those randomly assigned to Relvar could change to other asthma medication in addition to or instead of Relvar, and those on usual care could also do this but were not permitted to initiate Relvar

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.

Graph

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

Improve asthma control

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Relvar – greater improvements across all 5 ACT components vs. other ICS/LABAs*,11

Graph

*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).11

Relvar – achieves meaningful improvement in asthma control vs. other ICS/LABAs11

Graph

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/LABA11

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 life11

Graph

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 Intention To Treat (ITT) population prescribed ICS/LABA at baseline who were initiated with Relvar or continued on their existing ICS/LABA. Data showed a relative difference of 27% and an absolute difference of 12%.

Relvar – superior across all domains of the AQLQ vs. other ICS/LABAs11

Graph

*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.

The Asthma Quality of Life Questionnaire (AQLQ) is clinically validated to assess the physical and emotional impact of asthma on patients' lives13

Graph
Download the full SLS
PDF - 2.42MB

Safety profile

Relvar is generally well tolerated; the most commonly reported adverse reactions were headache and nasopharyngitis.6 View the full safety profile

Relvar - designed for effectiveness

When developing Relvar, we focused our efforts on the deliberate design of a medicine which can deliver greater patient benefit and address the need for lasting molecules in once-daily dosing.

Take a look at the innovation behind creating a once-a-day medicine with 24-hour molecules.

  • The video provides more information about the pharmacological properties of fluticasone furoate (FF) and vilanterol (VI).
  • FF possesses a unique molecular structure that, when inhaled, gives prolonged topical activity. It is designed to target and bind to the glucocorticoid receptor in the lungs and where not bound, is rapidly inactivated. This enables sustained anti-inflammatory activity in the airways.14
  • VI demonstrates a long, highly selective connection with the B2 receptor due to an additional oxygen atom. It sustains airway bronchodilation for 24 hours.15

    fluticasone furoate and vilanterol are not licensed as asthma monotherapy medicines
Relvar Ellipta
Long duration of action

Long duration of action

High receptor binding affinity14
Low systemic exposure6,14

Over 24 hours

Over 24 hours

Lasting anti-inflammatory effects for over 24 hours after treatment2,3

15 minute action

15 minute action

Rapid bronchodilation within 15 minutes2

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

It’s hard for us to get it right all the time. Incorrect inhaler use is common and associated with poor disease control.16
Make it easier for your patients to get the full benefit of the medicine with the Ellipta inhaler.

Ellipta – easy-to-use5

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 MDI5

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

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. Turbohaler5

Critical errors

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

Order a demo device

Learn how to use the Ellipta device

Asthma patient support

Get started with Relvar for your patients

Asthma Control Test (ACT) pads

Asthma Control Test (ACT) pads

Patient self-assessment tool of asthma control.

Ellipta demonstration device

Ellipta demonstration device

Demonstration device for you to show patients how to use the Ellipta device correctly.

Asthma patient support pack

Asthma patient support pack

A booklet to support patients who have been prescribed Relvar, better understand their asthma diagnosis and their Relvar Ellipta inhaler.

Support your knowledge of asthma

The educational content that you are interested in

Off Your Chest

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?

Superior asthma
control

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

Designed for
effectiveness

Lasting anti-inflammatory and bronchodilatory effect with fluticasone furoate/vilanterol2,3

Once-daily
dosing

Once-daily ICS/LABA in a patient-preferred and easy-to-use device4,5

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. 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
  3. 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.
  4. 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
  5. 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.
  6. Relvar Ellipta SmPC 2019
  7. Nathan RA, et al. Development of the asthma control test: a survey for assessing asthma control. J Allergy Clin Immunol. 2004;113:59–65;
  8. Schatz M, et al. The minimally important difference of the Asthma Control Test. J Allergy Clin Immunol. 2009;124:719–23.e1
  1. 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.
  2. 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
  3. 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.
  4. GSK. Clinical Study Report. 2017; HZA115150. Last accessed May 2019 (Table 27, page 114)
  5. Juniper EF, et al. Determining a minimal important change in a disease specific quality of life questionnaire. J Clin Epidemiol 1994; 47:81-87
  6. Daley-Yates PT. Inhaled corticosteroid: potency, dose equivalence and therapeutic index. Br J Clin Pharmacol 2015.
  7. 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
  8. 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
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Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard 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

N.A. Last updated: June 2019. PM-GB-FFV-WCNT-190015