Efficacy and tolerability of once-daily 5mg desloratadine, an H-1-receptorantagonist, in patients with seasonal allergic rhinitis - Assessment during the spring and fall allergy seasons

Objective: To evaluate the efficacy and tolerability of desloratadine 5mg o nce daily, a new, selective, H-1-receptor antagonist, for the treatment of patients with seasonal allergic rhinitis (SAR) during the two major pollen seasons in the USA. Design: Two multicentre, randomised, double-blind, placebo-controlled, para llel-group investigations in patients with SAR are reported, one conducted during the spring (172 and 174 patients in the desloratadine and placebo gr oups, respectively) and the other during the fall (164 patients each in the desloratadine and placebo groups) allergy season. Study Participants: Patients 12 years of age or older with clinically sympt omatic SAR and a minimum 2-year history of SAR. Interventions: Desloratadine 5mg or placebo once daily for 14 days followin g a 1-week screening period. Main Outcome Measures: The primary efficacy assessment was the mean change from baseline in the average reflective am/pm total symptom score (TSS) ave raged over the 2-week study period. Results: In both seasons, desloratadine 5mg once daily resulted in a signif icant improvement in TSS for patients with SAR (p < 0.01 and p = 0.02, resp ectively) over the a-week study. Adverse events reported were mild to moder ate in severity and similar to placebo. Assessment of sedation and ECG data revealed no clinically significant changes from baseline with desloratadin e- or placebo-treated patients. Conclusion: Desloratadine 5mg once daily was effective and well tolerated i n the treatment of symptoms associated with SAR following the first dose of therapy and continuing for the 2-week duration of the study during both th e spring and fall allergy seasons.