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Protecting against exacerbations
Asthma control isn’t just about reducing symptoms – it’s about reducing future exacerbations too.1
With Relvar, asthma patients can reduce their rate of exacerbations vs both BUD/Form and ICS, as proven in real-world and clinical settings, respectively.2,3
This was a retrospective cohort study matching 18,531 adult asthma patients initiating once-daily FF/VI 100/25 μg to 18,531 patients initiating twice-daily BUD/Form 160/4.5 μg by propensity score, using a US claims database (1 January 2015–31 December 2018).2 The primary study endpoint was SABA canisters dispensed PPY (Relvar 1.47 vs BUD/Form 1.64; RR 0.90, 95% CI 0.86–0.93; p<0.001; AR 0.17).2
This was a retrospective cohort study matching 18,531 adult asthma patients initiating once-daily FF/VI 100/25 μg to 18,531 patients initiating twice-daily BUD/Form 160/4.5 μg by propensity score, using a US claims database (1 January 2015–31 December 2018).2 The primary study endpoint was SABA canisters dispensed PPY (Relvar 1.47 vs BUD/Form 1.64; RR 0.90, 95% CI 0.86–0.93; p<0.001; AR 0.17).2
25% relative reduction
in exacerbations3
(95% CI 5–40%, p=0.014)
This graph has been independently created by GSK from the original data. The same results were first published in Bateman ED, et al. Thorax 2014;69:312–319.
This was a randomised, double-blind, comparative, event-driven study of variable duration (≥24–78 weeks) designed to finish after 330 events (each patient’s first on-treatment severe asthma exacerbation).3 Patients with asthma aged ≥12 years with ≥1 recorded exacerbation within 1 year (N=2019) were randomised and received FF/VI 100/25 μg or FF 100 μg, administered once daily in the evening.3 The primary endpoint was time to first severe exacerbation.3
Monitoring SABA use
SABA use is a key indicator of asthma control. If a patient is using their SABA more than twice per week, it could indicate poor control.‡1
Compared with BUD/Form, Relvar is associated with a 10% reduction in SABA use in real-world settings.2
This graph has been independently created by GSK from the original data. The same results were first published in Averell CM, et al. J Asthma 2022;59:1805–1818.
Discover Relvar
21st-century molecules[4–7]
Relvar’s unique combination of fluticasone furoate, a potent inhaled corticosteroid, and vilanterol, an ultra-long-β2-agonist, delivers the everyday stability asthma patients need.2,4,5,8–15
Footnotes
*Defined as a moderate or severe asthma-related exacerbation. Moderate exacerbation: an asthma-related emergency department (ED) or outpatient visit with a systemic/oral corticosteroid dispensing within ±5 days of the visit.2
†Severe exacerbation: an asthma-related hospitalisation or asthma-related ED visit resulting in hospitalisation within +1 day.2
‡Within the last four weeks. Other important criteria include: daytime symptoms more than twice/week; any night waking due to asthma; any activity limitation due to asthma.1
Abbreviations
AE, adverse event; AR, absolute reduction; BUD, budesonide; CI, confidence interval; ED, emergency department; FF, fluticasone furoate; Form, formoterol; HR, hazard ratio; ICS, inhaled corticosteroid; PPY, per patient-year; RR, rate ratio; SABA, short-acting β2-agonist; VI, vilanterol.
Relvar Safety Information16
Contraindications
Hypersensitivity to the active substances or to any of the excipients.
Undesirable effects
Very Common: Headache, Nasopharyngitis.
Common: Infections and infestations, Oropharyngeal pain, Sinusitis, Pharyngitis, Rhinitis, Cough, Dysphonia, Abdominal pain, Arthralgia, Back pain, Fractures, Muscle spasms and Pyrexia.
References
- GINA. Global strategy for asthma management and prevention, 2023. Available at: www.ginasthma.org. Accessed April 2024.
- Averell CM, et al. J Asthma 2022;59:1805–1818.
- Bateman ED, et al. Thorax 2014;69:312–319.
- Bernstein DI, et al. J Asthma 2015;52:1073–1083.
- Global Datasheet Fluticasone furoate/vilanterol: v13, September 2022.
- Braithwaite I, et al. Respir Med 2016;119:115–121.
- Center for Drug Evaluation and Research. Approval package for Breo Ellipta. Application number: 204275Orig1s000. Accessed April 2024.
- Woodcock A, et al. Lancet 2017;390:2247–2255.
- Daley-Yates P, et al. Adv Ther 2023;40:4042–4059.
- Svedsater H, et al. Respir Med 2018;141:198–206.
- Parimi M, et al. Adv Ther 2020;37:2916–2931.
- van der Palen J, et al. NPJ Prim Care Respir Med 2016;26:16079.
- van der Palen J, et al. Respir Med 2022;205:107031.
- Janson C, et al. Thorax 2020;75:82–84.
- Woodcock A, et al. Thorax 2022;77:1187–1192.
- Relvar Prescribing Information.
GSK does not recommend, endorse, or accept liability for the 3rd party sites.
For more information, please refer to the prescribing information or contact GlaxoSmithKline via gcc.medinfo@gsk.com
To report Adverse Event/s associated with the use of GSK product/s, please contact us via
gulf.safety@gsk.com
To report quality complaint/s associated with the use of GSK product/s, please contact us via
Gulf.ProductQualityComplaints@gsk.com
Department of Pharmacovigilance & Drug Information |
دائرة التيقظ و المعلومات الدوائية مركز سلامة الدواء وزارة الصحة, سلطنة عمان هاتف: 0096822357687 / 0096822357690 0096822358489 :فاكس pharma-vigil@moh.gov.om :البريد االكتروني https://moh.gov.om/en/ : الموقع االكتروني |
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PM-RCH-FFV-WCNT-250001 Date of preparation: July 2025
