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Background  This placebo‐controlled study assessed the effects of the once‐daily inhaled corticosteroid ( ICS ) fluticasone furoate ( FF ) and long‐acting beta 2 ‐agonist ( LABA ) vilanterol ( VI ) on early and late asthmatic responses ( EAR / LAR ) and airway hyper‐responsiveness ( AHR ).    Methods  Patients ( n  =   27) were randomized to  FF  (100 μg),  VI  (25 μg),  FF / VI  (100/25 μg), and placebo for 21 days (four periods). Allergen challenge was performed 1 h post‐dose on day 21.  AHR  was assessed on day 22 using methacholine.    Results  Allergen challenge caused an early change (0–2 h) in minimum forced expiratory volume in 1 s ( FEV  1 ) of −1.091 l (95%  CI : −1.344; −0.837) following placebo therapy; changes were −0.955 l (−1.209; −0.702), −0.826 l (−1.070; −0.581), and −0.614 l (−0.858; −0.370) following  VI ,  FF , or  FF / VI  therapy, respectively. Treatment differences were significant for all comparisons between therapies. Mean changes in 0–2 h % FEV  1  were as follows: −28.05 (placebo), −23.10 ( VI ), −22.33 ( FF ), and −16.10 ( FF / VI ). Following placebo, the late change (4–10 h) in weighted mean  FEV  1  was −0.466 l (−0.589; −0.343) and −0.298 l (−0.415; −0.181) after  VI , and was +0.018 l with both  FF / VI  (−0.089; 0.124) and  FF  (−0.089; 0.125). Treatment differences were significant for all comparisons between therapies except  FF / VI   vs   FF . Mean changes in 4–10 h % FEV  1  were as follows: −21.08 (placebo), −14.30 ( VI ), −5.02 ( FF ), and −5.83 ( FF / VI ).  AHR  24 h after allergen challenge was significantly reduced with  FF / VI  and  FF   vs  placebo, and  FF / VI  was superior to either component.    Conclusion  Combined treatment with  FF / VI  provides additive protection from the  EAR  relative to its components, significant protection over  VI  alone from the  LAR , and confers sustained protection from hyper‐responsiveness 24 h post‐dose.

Modulation of allergen‐induced bronchoconstriction by fluticasone furoate and vilanterol alone or in combination