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Relvar (fluticasone furoate/vilanterol): Supporting your eligible patients with asthma 

Relvar Ellipta (fluticasone furoate/vilanterol) is indicated for the 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
  • patients already adequately controlled on both inhaled corticosteroid and long-acting beta2-agonist

How Relvar fits in the current treatment landscape

The unmet need in moderate-to-severe asthma

Explore the differences between perceived control and actual symptoms 

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Benefits of Relvar for eligible patients

Discover how Relvar’s molecular profile can benefit your patients

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Relvar offers eligible patients improved quality of life

Find out how Relvar improves the lives of patients

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Relvar's molecules

Discover how the combination of Relvar molecules can benefit your eligible patients

Read more

Relvar is generally well-tolerated

Read about Relvar’s safety profile

Read more

Consider Relvar for your patients with moderate-to-severe asthma

Meet the unmet needs of your patients by choosing Relvar today

Read more

The unmet need in moderate-to-severe asthma

Uncontrolled asthma refers to asthma symptoms impacting a person's lifestyle or restricting usual activities. It includes any asthma exacerbation requiring oral corticosteroids, and/or frequent regular symptoms such as needing a reliever inhaler three or more days per week, or night-time waking due to asthma once or more per week.1

Despite treatment, asthma symptom control is not always the reality for all patients.

Even though patients may perceive their asthma as controlled, the reality is that they may still suffer from symptoms.2

Figure showing that 57.1% (n=1216) of patients who consider their asthma to be well controlled still experience symptoms Figure showing that 57.1% (n=1216) of patients who consider their asthma to be well controlled still experience symptoms

Up to six out of 10 patients (57.1%; n=1216) considered their asthma to be well or completely controlled despite frequently experiencing symptoms2

This figure has been independently created by GSK from the original data.​
The same results were first published in Chapman et al. 2021.2

The Asthma Patients’ and Physicians’ Perspectives on the Burden and Management of Asthma (APPaRENT) study was a multinational, cross-sectional online survey of patients and physicians in four countries: Australia, Canada, China, and the Philippines. Inclusion criteria: age ≥18 years, current/past physician diagnosis of asthma (patients); primary care treating ≥4 patients with asthma per month, ≥3 years in clinical practice (physicians). Overall, 1216/70183 patients and 803/8376 physicians replied and were eligible for inclusion.​

Fewer than 10% of patients say their asthma is ‘not controlled’ or ‘poorly controlled’; despite more than 50% reporting frequent symptoms, suggesting they do not have well-controlled asthma3

The Asthma Patients’ and Physicians’ Perspectives on the Burden and Management of Asthma (APPaRENT) 2 study was a multinational, cross-sectional online survey of patients and physicians in five countries: Argentina, Brazil, France, Italy and Mexico. Inclusion criteria: age ≥18 years, current/past physician diagnosis of asthma, ≥6 months prescribed inhaler use (patients); primary care treating ≥4 patients with asthma per month, ≥3 years in clinical practice (physicians). Overall, 1650 patients and 1080 physicians were included. Not controlled at all: 1% (23/1650); poorly controlled: 8% (127/1650).

Benefits of Relvar for eligible patients

25% more patients improved their asthma control (fewer nocturnal symptoms/fewer daytime symptoms/less use of rescue inhalers) at Week 24 vs other commonly prescribed inhaled corticosteroids (ICS)/long-acting beta2-agonists (LABAs) in everyday practice (fluticasone propionate [FP]/salmeterol [SM], 30%; budesonide [BUD]/formoterol [Form], 15%; and beclomethasone dipropionate [BDP]/Form, 12%) in the primary efficacy analysis (PEA) population (relative difference, 14% absolute difference).4,5

This was an open-label, randomised, controlled, two-arm effectiveness study of patients aged ≥18 years with symptomatic asthma at 74 general practice clinics in Salford and South Manchester, UK. Patients were assigned to either fluticasone furoate (FF)/vilanterol (VI) 100/25 or 200/25 once-daily (OD), or optimised usual care and followed up for 12 months. Usual care was ICS or ICS/LABA. ICS monotherapy in the usual care group included BDP, BUD, ciclesonide and fluticasone. ICS/LABAs in the usual care group included BDP/Form, BUD/Form, FP/Form and FP/SM. The primary endpoint was the proportion of Asthma Control Test (ACT) responders (improvement from baseline of ≥3 or achieving a total ACT score ≥20) in patients initiated on Relvar vs continuing on usual care (as prescribed by GP) at Month 6 in the PEA population. The primary endpoint was met (p<0.0001). Data presented are from a subset of patients prescribed ICS/LABA at baseline initiated on Relvar or continued on their ICS/LABA. 25% relative difference in responders; 14% absolute difference (637 [70%]) responders vs 511 [56%] responders for Relvar and ICS/LABA, respectively). 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.

Proportion of ACT responders at 6 months (%)

Bar graph showing 25% more patients show an improvement in asthma control at 24 weeks vs other commonly prescribed ICS/LABAs (FP/SM, 30%; BUD/Form, 15%; and BPD/Form, 12%) in the PEA population (relative difference, 14% absolute difference) Bar graph showing 25% more patients show an improvement in asthma control at 24 weeks vs other commonly prescribed ICS/LABAs (FP/SM, 30%; BUD/Form, 15%; and BPD/Form, 12%) in the PEA population (relative difference, 14% absolute difference)

Other ICS/LABAs commonly prescribed which were Seretide (FP/SM, 30%), Symbicort (BUD/Form, 15%), Fostair (BDP/Form, 12%), in the PEA population at 24 weeks. This figure has been independently created by GSK from the original data.​ The same results were first published in Woodcock et al. 2017.4

Patients have a higher mean change in symptom improvement from baseline score with Relvar vs other commonly used ICS/LABAs.5–7

This was a post hoc analysis of an open-label, randomised, controlled, two-arm effectiveness study of 4233 patients aged ≥18 years with symptomatic asthma at 74 general practice clinics in Salford and South Manchester, UK. Patients were assigned to either FF/VI 100/25 or 200/25 OD, or optimised usual care and followed up for 12 months. Other commonly used ICS/LABAs group included BDP/Form, BUD/Form, FP/Form and FP/SM. The composite primary effectiveness endpoint was the percentage of ACT responders at Week 24, defined as patients who achieved an ACT total score ≥20 and/or an improvement from baseline ≥3. Odds ratios (ORs) favoured FF/VI over usual care in both cases: OR 2.00 (95% CI 1.70–2.34).

Mean change from baseline ACT components score at 6 months

Bar graph showing Relvar vs ICS/LABA on asthma symptoms and perceived asthma control. Relvar provides improvements in night-time awakenings due to asthma, shortness of breath due to asthma, rescue medication use, effect of asthma on activity levels and patient’s perception of asthma control Bar graph showing Relvar vs ICS/LABA on asthma symptoms and perceived asthma control. Relvar provides improvements in night-time awakenings due to asthma, shortness of breath due to asthma, rescue medication use, effect of asthma on activity levels and patient’s perception of asthma control

*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).6,7

This figure has been independently created by GSK from the original data.​
The same results were first published in Svedsater et al. 2018.6,7

Switching symptomatic asthma patients from twice-daily (BD) ICS/LABAs (including BUD/Form and FP/SM) to OD Relvar improved asthma symptoms, lung function, and inflammation.8

This was a prospective, 3-month, open-label, parallel group, switching therapy trial performed in symptomatic asthma patients under routine management. Patients using 1 puff of FP/SM 250/50 μg BD or 2 puffs of BUD/Form 160/4.5 μg BD were switched to FF/VI 100/25 μg OD, while patients using 1 puff of FP/SM 500/50 μg BD or 4 puffs of BUD/Form 160/BD was switched to FF/VI 200/25 μg OD (N=35). The primary outcome was improvement of the predicted forced expiratory volume in 1 second % (%FEV1). %FEV1 improved at 4 weeks after switching from previous ICS/LABA to FF/VI therapy, and this improvement was maintained until 12 weeks (p<0.05 vs Week 0). 

Relvar offers patients improved quality of life

In a post hoc analysis of an open-label, randomised study, Relvar has been shown to increase the number of patients with clinically relevant quality of life (QoL) improvements - both overall and individual components - vs other ICS/LABAs over a 12-month follow-up period (p<.001).7

This was a post hoc analysis of a randomised, controlled, two-arm effectiveness study (the Salford Lung Study) of patients aged ≥18 years with symptomatic asthma. Patients were assigned to either Relvar 100/25 or 200/25 OD, or optimised usual care (this included other ICS/LABAs commonly prescribed which were Seretide [FP/SM, 30%], Symbicort [BUD/Form, 15%], Fostair [BDP/Form, 12%] and followed up for 12 months). When Asthma Quality of Life Questionnaire [AQLQ] domains were analysed individually (environmental, symptoms, emotional impact, activity levels), patients on FF/VI saw significant improvements from baseline across all domains compared with continuing on other ICS/LABAs (p<0.001 for all comparisons). Improvement in QoL is a consequence of successful asthma management.

AQLQ responders at 12 months (%)*

Bar graph showing the percentage that 56% (n=669/1197) of patients on Relvar vs 44% of patients on ICS/LABAs were AQLQ responders at 12 months (Overall Response [OR]: 1.79, 95% Confidence Interval [CI]: 1.51, 2.13; p<0.001) Bar graph showing the percentage that 56% (n=669/1197) of patients on Relvar vs 44% of patients on ICS/LABAs were AQLQ responders at 12 months (Overall Response [OR]: 1.79, 95% Confidence Interval [CI]: 1.51, 2.13; p<0.001)

*Data from a post hoc analysis.
†QoL was measured by the AQLQ at 12 months. A clinically meaningful improvement was defined as an increase from baseline of ≥0.5 units. 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/LABAs.7
‡Analysis of the environmental stimuli domain was pre-planned.7

This figure has been independently created by GSK from the original data. The same results were first published in Svedsater et al. 2018.7

27% more patients improved their QoL vs other commonly used ICS/LABAs in everyday practice (the proportion of AQLQ (S) responders was 56% (669/1197) for FF/VI and 44% (528/1209) for usual care; absolute increase 12%; p<0.001).7,9

This was a post hoc analysis of a randomised, controlled, two-arm effectiveness study of 4,233 patients aged ≥18 years with symptomatic asthma at 74 general practice clinics in Salford and South Manchester, UK. Patients were assigned to either FF/VI 100/25 or 200/25 OD, or optimised usual care and followed up for 12 months. The composite primary effectiveness endpoint was the percentage of ACT responders at Week 24, defined as patients who achieved an ACT total score of ≥20 and/or an improvement from baseline ≥3. At baseline, the most commonly prescribed ICS/LABAs were FP/SM, BUD/Form, and BDP/Form. AQLQ (S) responders were defined as patients with an increase from baseline of ≥0.5 points at Week 52. Any impact on quality of life is a consequence of successful asthma management.

AQLQ responders at 12 months (%)*

Figure showing that Relvar provides superior QoL across all AQLQ domains, including reduced response to environmental stimuli, reduced asthma symptoms, reduced emotional impact of asthma, and increased activity levels, vs other commonly used ICS/LABAs over a 12-month follow-up period Figure showing that Relvar provides superior QoL across all AQLQ domains, including reduced response to environmental stimuli, reduced asthma symptoms, reduced emotional impact of asthma, and increased activity levels, vs other commonly used ICS/LABAs over a 12-month follow-up period

*Quality of life was measured by the AQLQ questionnaire at 12 months. A clinically meaningful improvement was defined as an increase from baseline of ≥0.5 units. 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.6

This figure has been independently created by GSK from the original data. The same results were first published in Svedsater et al. 2018 (Supplemental).6

Relvar provided a 61% relative reduction in workplace impairment due to asthma (WPAI) vs commonly used ICS/LABAs at Week 52 (7.1% vs 4.4% for FF/VI and commonly used ICS/LABAs, respectively; absolute reduction 2.7%; 95% CI -5.0 to -0.4, p=0.19)5,7,9

This was a post hoc analysis of an open-label, randomised, controlled, two-arm effectiveness study of patients aged ≥18 years with symptomatic asthma at 74 general practice clinics in Salford and South Manchester, UK. Patients were assigned to either FF/VI 100/25 or 200/25 OD, or optimised usual care and followed up for 12 months. The composite primary effectiveness endpoint was the percentage of ACT responders at Week 24, defined as patients who achieved an ACT total score ≥20 and/or an improvement from baseline ≥3. At baseline, the most commonly prescribed ICS/LABAs were FP/SM, BUD/Form, and BDP/Form. Commonly used ICS/LABAs group included BDP/Form, BUD/Form, FP/Form and FP/SM. Data based on last available on-treatment measurement (Week 52 or early withdrawal visit). For analysis of the ICS/LABA subset of the overall study population, the statistical models did not include the asthma maintenance therapy at baseline per randomisation stratification variable. Improvement in QoL is a consequence of successful asthma management.

Relvar’s molecules

Fluticasone furoate

Relvar’s fluticasone furoate, with its anti-inflammatory activity, has demonstrated greater airway protection and less systemic effect vs budesonide, in vitro.10,11

In vitro data. The clinical relevance is uncertain. FF is not licensed as monotherapy for the treatment of asthma. This was an escalating dose, placebo-controlled, incomplete block, two-period, crossover study of patients aged 18–65 with a history of bronchial asthma first diagnosed at least 6 months prior to screening. The primary objective of the study was to characterise the dose-response and relative potency of FF, FP, and BUD in reducing airway hyperresponsiveness via AMP challenge (provocative concentration of adenosine 5'-monophosphate [AMP] producing a 20% decline in FEV1; AMP PC20). The therapeutic index was calculated by dividing the dose producing 50% of maximum suppression (ED50) of cortisol by the ED50 AMP PC20. This study also included unlicensed doses of budesonide and fluticasone propionate – see full reference Daley-Yates PT, et al. Br J Clin Pharmacol 2021;87:483–493 for details. BUD 400 μg BD, 23.91 (95% CI 15.08–37.90) vs FF 100 μg OD, 81.45 (95% CI 44.65–148.58).

FF targets underlying inflammation, with more airway protection and less systemic effect vs BUD*10

Bar graph showing that FF treats underlying inflammation with more airway protection and less systemic effect vs BUD Bar graph showing that FF treats underlying inflammation with more airway protection and less systemic effect vs BUD

*In vitro data. The clinical relevance is uncertain.
This figure has been independently created by GSK from the original data.​
The same results were first published in Daley-Yates et al. 2021.10

Fluticasone furoate demonstrated higher glucocorticoid receptor affinity and a longer duration of action compared to budesonide in vitro.12,13

The retention of FF and other ICS in respiratory tissue was investigated using a monolayer of human lung epithelial (16HBE14o) cells. Cell association of ICS at the cell monolayer was determined and quantified as total recovery. In vitro data. The clinical relevance is uncertain. FF is not licensed as a monotherapy in asthma. The duration of action of FF and BUD were compared in cultured human respiratory cells.

Vilanterol

Vilanterol has 23× higher affinity for the β2 adrenoceptor than formoterol.14

In vitro data; the clinical relevance is uncertain.

Vilanterol has a significantly faster onset than salmeterol in vitro (5.8 ± 0.5 mins vs 15.2 ± 0.6 mins; p<0.0001).14

Onset times were determined in electrical field stimulated (EFS) guinea pig trachea and measured as the time taken to reach half-maximal inhibition obtained for an approximate half maximal effective concentration (EC50) of B2-adrenoceptor agonist. In vitro data. The clinical relevance is uncertain. Vilanterol is not licensed as monotherapy for asthma. 

Vilanterol demonstrated rapid and sustained bronchodilation over 24 hours.15,16

Vilanterol is not licensed as monotherapy in COPD or Asthma. Data from four Phase I (n=97) and a Phase II (n=454) studies on healthy volunteers/patients.

Relvar is generally well-tolerated

Relvar has a generally well-tolerated safety profile, with adverse events consistent with the ICS/LABA class of medication.17

System organ class Adverse reaction(s) Frequency
Infections and infestations Pneumonia
Upper respiratory tract infection
Bronchitis
Influenza
Candidiasis of mouth and throat		 Common
Immune system disorders Hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria. Rare
Metabolism and nutrition disorders Hyperglycaemia Uncommon
Psychiatric disorders Anxiety Rare
Nervous system disorders Headache
Tremor		 Very common
Rare
Eye disorders Vision blurred Uncommon
Cardiac disorders Extrasystoles
Palpitations
Tachycardia		 Uncommon
Rare
Rare
Respiratory, thoracis and mediastinal disorders Nasopharyngitis Very common
Oropharyngeal pain
Sinusitis
Pharyngitis
Rhinitis
Cough
Dysphonia		 Common
Paradoxical bronchospasm Rare
Gastrointestinal disorders Abdominal pain Common
Musculoskeletal and connective tissue disorders Arthralgia
Back pain
Fractures
Muscle spasms		 Common
General disorders and administration site conditions Pyrexia Common

Consider Relvar for your patients with moderate-to-severe asthma

Looking for ways to improve care in poorly controlled asthma?
Consider the benefits Relvar can offer your eligible patients today. 

Relvar Ellipta (fluticasone furoate/vilanterol) is indicated for the 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
  • patients already adequately controlled on both inhaled corticosteroid and long-acting beta2-agonist

Abbreviations

ACT, Asthma Control Test; AMP PC20, provocative concentration of adenosine 5'-monophosphate [AMP] producing a 20% decline in FEV1; AQLQ, Asthma Quality of life Questionnaire; BD, twice a day; BDP, beclomethasone dipropionate; BUD, budesonide; CI, confidence interval; COPD, Chronic Obstructive Pulmonary Disease; EC50, half maximal effective concentration; ED50, dose producing 50% of maximum suppression; EFS, electrical field stimulation; FEV1, forced expiratory volume; FF, fluticasone furoate; Form, formoterol; FP, fluticasone propionate; HR, hazard ratio; HRQoL, health-related quality of life; ICS, inhaled corticosteroids; ITT, intention-to-treat; LABA, long-acting beta2-agonist; OD, once a day; OR, overall response; PEA, primary efficacy analysis; QoL, quality of life; SM, salmeterol; UC, usual care; VI, vilanterol; WPAI, workplace impairment due to asthma.

References

  1. National Institute for Health and Care Excellence. Asthma: diagnosis, monitoring and chronic asthma management (BTS, NICE, SIGN) [NG245]. Available at: https://www.nice.org.uk/guidance/NG245. Accessed: July 2025.
  2. Chapman KR, et al. Respir Med. 2021;186:106524.
  3. Chapman KR, et al. Respir Med. 2022;201:106948.
  4. Woodcock A, et al. Lancet. 2017;390(10109):2247–2255.
  5. GSK Data on File 219213; 2023.
  6. Svedsater H, et al. Respir Med. 2018;141:198–206. Supplementary material.
  7. Svedsater H, et al. Respir Med. 2018;141:198–206.
  8. Shimizu Y, et al. J Thorac Dis. 2020;12:1877–1883.
  9. GSK clinical study report. HZA115150; 2017. Accessed: June 2025.
  10. Daley-Yates P, et al. Br J Clin Pharmacol. 2021;87:483–493.
  11. Daley-Yates P, et al. Br J Clin Pharmacol. 2021;87:483–493. Supplementary material.
  12. Salter M, et al. Am J Physiol Lung Cell Mol Physiol. 2007;293(3):L660–L667.
  13. Rossios C, et al. Eur J Pharmacol. 2011;670(1):244–251.
  14. Slack RJ, et al. J Pharmacol Exp Ther. 2013;344:218–230.
  15. Kempsford R, et al. Pulm Pharmacol Ther. 2013;26(2):256–264.
  16. Hanania NA, et al. Chest. 2012;142(1):119–127.
  17. Relvar Ellipta Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/5226/smpc/print. Accessed: July 2025.

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/. Adverse events should also be reported to GlaxoSmithKline on 0800 221 441 or UKSafety@gsk.com.

July 2025 I PM-GB-FFV-WCNT-250001 (V1.0)