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Relvar (fluticasone furoate/vilanterol) is indicated for the regular treatment of asthma in adults and adolescents aged 12 years and older for whom use of a combination product containing a long-acting β₂-agonist (LABA) and an inhaled corticosteroid (ICS) is appropriate, including patients not adequately controlled with ICS and ‘as-needed’ inhaled short-acting β₂-agonists, and those who are already adequately controlled on both ICS and LABA.1
Prescribing information for fluticasone furoate/vilanterol (FF/VI) can be found here. Registration conditions may differ in your country. Please refer to the label in your country for local prescribing information. Adverse event reporting information can be found at the end of this webpage.
Effectiveness Study of FF/VI vs BDP/Form in Newly Treated Patients on ICS/LABAs
For patients with moderate-to-severe asthma, choice of ICS/LABA is key when considering treatment recommendations.2-4
Two recently published studies provide new data from real-world clinical practice comparing once-daily FF/VI with two twice-daily ICS/LABA options: beclomethasone dipropionate / formoterol (BDP/Form) and budesonide / formoterol (BUD/Form)(Supplementary table S6, Woodcock et al.2, Supplementary table S6, Woodcock et al3)
Assessments in the studies included asthma exacerbation rate and other outcomes (treatment persistence, oral corticosteroid (OCS) use) among patients newly initiated on ICS/LABA, including a subgroup analysis of patients who stepped up to ICS/LABA from ICS monotherapy. (Supplementary table S6, Woodcock et al.2, Supplementary table S6, Woodcock et al3)
These were two retrospective cohort studies using de-identified, linked data in England from the CPRD Aurum and HES databases.2,3 The first study included patients aged ≥18 years newly initiating BDP/Form (N=46,809) or FF/VI (N=3773).2 The second study included patients aged ≥18 years newly initiating BUD/Form (N=14,464) or FF/VI (N=3774).3 In both studies the primary endpoint was a comparison of the rate of overall asthma exacerbations in patients newly indexed to either of the medications. Secondary outcomes included the time to first asthma exacerbation, medication persistence and OCS use. Moderate asthma exacerbations were defined as events requiring OCS prescription. Severe exacerbation was defined as: hospitalisation related to asthma, emergency department visit related to asthma, or a coded severe exacerbation event in a medical record. The data presented focus on a subgroup of patients who stepped up from ICS plus SABA to an ICS/LABA combination therapy, in line with their therapeutic indications; data from the overall study population does not represent indicated use. The results in the step-up populations were consistent with the overall study populations. Selection bias due to inclusion criteria may affect the generalisability of the results. The prescription medications may not have been consumed by patients as prescribed.(Supplementary table S6, Woodcock et al.2, Supplementary table S6, Woodcock et al3)
Adverse events should be reported. Reporting form and information can be found at https://yellowcard.mhra.gov.uk or search for MHRA Yellowcard in the Google Play or Apple Store. Adverse events should also be reported to GSK on 0800 221 441 or [email protected].
References:
1. Relvar (fluticasone furoate/vilanterol) Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/5226/smpc. Last accessed: 28 November 2025,
2. Woodcock A et al. Real-world comparative effectiveness study in patients with asthma initiating fluticasone furoate/vilanterol or beclometasone dipropionate/formoterol fumarate in general practice in England. Adv Ther. 2025;42:5960–77.
3. Woodcock A et al. Real-world comparative effectiveness in patients with asthma newly initiating fluticasone furoate/vilanterol or budesonide/formoterol: a United Kingdom general practice cohort study. Pulm Ther. 2025;11(4):705-22.
4. Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention. 2025. Available at: https://www.ginasthma.org. Last accessed 6 November 2025.
PM-GBL-FFV-WCNT-250008
December 2025
