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A randomized, double-blind, placebo-controlled, parallel-group study of once-daily inhaled fluticasone furoate on the hypothalamic–pituitary–adrenocortical axis of children with asthma

Allergy, Asthma & Clinical Immunology Feb 07, 2020

Bareille P, Tomkins S, Imber V, et al. - Researchers undertook this randomized, double-blind, placebo-controlled, multicenter, stratified, parallel-group, non-inferiority study to assess the influences of fluticasone furoate on hypothalamic–pituitary–adrenocortical axis, as well as the safety and tolerability of fluticasone furoate to treat children suffering from asthma. Participants were children (aged 5–11 years inclusive) with a reported diagnosis of asthma for ≥ 6 months and a Childhood Asthma Control Test score of > 19. The participants were randomized to receive fluticasone furoate 50 µg once daily (n = 56) and received placebo (n = 55). Findings revealed that the hypothalamic–pituitary–adrenocortical axis function of children who received 6 weeks of treatment with inhaled fluticasone furoate 50 µg once daily was not influenced in a clinically relevant manner after this treatment, as measured by 24-h serum cortisol profiles. Non-inferiority of fluticasone furoate 50 µg once daily to placebo was demonstrated in the primary analysis. Good tolerability of fluticasone furoate 50 µg once daily, as well as no new safety concerns related to this regimen, were reported.
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