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Table 1 Double blind randomized trials in seasonal AR

From: Bilastine: new insight into antihistamine treatment

Study Patients N. Duration Treatment Efficacy Safety vs active comparator
Kuna P et al. [24] 683 14 days Bilastine 20 mg Cetirizine 10 mg Placebo The mean TSS-AUC0_14 days (score_day) was reduced in bilastine and cetirizine groups to a similar and significantly greater extent, compared with placebo (P < 0.001). Bilastine and cetirizine were comparable and significantly superior to placebo for all secondary outcomes Significantly fewer patients in the bilastine-treated group experienced somnolence (P < 0.001) and fatigue (P = 0.02) than patients in the cetirizine-treated group.
Bachert C et al. [23] 721 14 days Bilastine 20 mg Desloratadine 5 mg Placebo The AUC of TSS was decreased to a significantly greater extent in the bilastine group compared with placebo group (P < 0.001). Total RQLQ score was significantly reduced from baseline by a value of 1.6 (1.2; 1.8–1.4) in the bilastine treated group compared with a value of 1.3 (1.3; 1.5–1.1) in the placebo-treated group (P < 0.005) Safety profile of bilastine and desloratadine were comparable to placebo.
  1. TSS-AUC0_14: area under the curve (AUC) of the reflective total symptoms score (TSS) from day 0 (D0) today 14; RQLQ: rhinoconjunctivitis quality of life questionnaire.