FEV₁ improved significantly at 12 weeks in patients treated with fluticasone furoate plus vilanterol compared with monotherapy, with no new safety issues.

Philippe Bareille presented the results from a global, randomized trial comparing treatment with inhaled corticosteroids plus a long-acting bronchodilator with treatment with inhaled corticosteroids alone in patients aged 5 to 17 years with uncontrolled asthma taking inhaled corticosteroids. A total of 864 patients were randomly assigned 1:1 to receive either fluticasone furoate monotherapy or fluticasone furoate plus vilanterol. Patients aged 5 to 11 (n=652) received 50 μg fluticasone furoate daily, whereas patients aged 12 to 17 received 100 μg of this medication daily. 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, favoring 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 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 two treatment groups. 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 (5-11 years),” concluded Dr. Bareille.

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