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Fluticasone furoate ( FF ) is a novel inhaled corticosteroid with 24‐h activity.  FF  is in development as a once‐daily treatment for asthma as monotherapy and in combination with vilanterol ( VI ), a long‐acting β 2  agonist. Corticosteroids can have systemic effects on hypothalamic‐pituitary‐adrenal ( HPA ) axis function, potentially resulting in cortisol suppression.    Objectives  To assess the effect of  FF / VI  compared with placebo on the  HPA  axis by evaluating 24‐h weighted mean serum cortisol levels in adolescent and adult patients with persistent asthma.    Methods  One hundred eighty‐five patients with >12 weeks history of asthma were randomised in a 4:4:4:1 ratio to one of two once‐daily  FF / VI  treatments (100/25 μg or 200/25 μg), placebo or an active control group that received inhaled placebo plus one prednisolone 10 mg capsule daily for the last 7 days of the study. Twenty‐four‐hour serum and urinary cortisol was measured at baseline and on day 42.    Results  Non‐inferiority in 24‐h weighted mean serum cortisol after 6 weeks of treatment with once‐daily  FF / VI  at either strength was shown. Treatment ratios [95% confidence interval ( CI )] to placebo for  FF / VI  100/25 μg [0.99 (0.87–1.12)] or  FF / VI  200/25 μg [0.97 (0.86–1.10)] indicated non‐inferiority of both  FF / VI  doses to placebo as the lower limit of the 95%  CI  was greater than the predefined 0.8. Prednisolone substantially reduced 24‐h weighted mean serum cortisol [treatment ratio to placebo 0.34 (0.28–0.41)].  FF / VI  was well‐tolerated, and no safety concerns were identified.    Conclusions   FF / VI  was found to be non‐inferior to placebo on  HPA  axis function, with no indication of significant cortisol suppression after 42 days.

the clinical respiratory journal

Inhaled fluticasone furoate/vilanterol does not affect hypothalamic‐pituitary‐adrenal axis function in adolescent and adult asthma: randomised, double‐blind, placebo‐controlled study