Success for fluticasone furoate plus vilanterol in uncontrolled asthma

Children between 5–17 years with uncontrolled asthma, taking inhaled corticosteroids, had a significantly improved forced expiratory volume in 1 second (FEV1) at 12 weeks if they were treated with fluticasone furoate plus vilanterol compared with fluticasone furoate alone.  

Dr Philippe Bareille (GSK, UK) presented the results from a global, randomised trial comparing treatment with inhaled corticosteroids plus a long-acting bronchodilator with treatment with inhaled corticosteroids alone in patients aged 5–17 years old with uncontrolled asthma on inhaled corticosteroids [1]. In total, 864 patients were randomised 1:1 to fluticasone furoate monotherapy or to fluticasone furoate plus vilanterol. Patients aged between 5 and 11 years (n=652) received 50 μg fluticasone furoate daily, whereas patients aged 12–17 received 100 μg of this agent on a daily base. The primary outcome was the weighted mean FEV1 (0–4 hours) at week 12.  

The primary endpoint was met with an adjusted treatment difference of 0.083 L, favouring the combination arm over the monotherapy arm (95% CI 0.037–0.129). Similarly, both morning (adjusted treatment difference 6.2 L/min) and afternoon (adjusted treatment difference 8.2 L/min) peak expiratory flow (PEF) data showed a significant advantage of the combination regimen over the monotherapy regimen. In contrast, clinical outcome measures, such as 24-hour rescue-free periods or 24-hour symptom-free periods did not demonstrate a difference between the 2 treatment groups. Finally, the combination therapy was well tolerated, and the safety analysis did not reveal new safety issues. 

“The combination of fluticasone furoate plus vilanterol improved the FEV1 of patients with uncontrolled asthma in a treatment cohort that included a large population of young patients,” concluded Dr Bareille. 

1. Bareille P, et al. A randomised, double-blind, parallel group, multicentre, stratified study evaluating the efficacy and safety of once-daily fluticasone furoate/vilanterol compared with once-daily fluticasone furoate in the treatment of asthma in participants aged 5-17 years old currently uncontrolled on inhaled corticosteroids. Session A13, ATS International Conference 2023, 19–24 May, Washington DC, USA. 

 

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Posted on 12 June 20235 October 2023