Sensitization to cockroach allergens in individuals with perennial rhinitis in belarus

Abstract

18 years, who achieved adequate symptoms after priming with ragweed pollen were randomized to one dose of DL 5 mg (n=81), DPH 50 mg (n=84), or placebo (n=83). A battery of repeatable, automated neuropsychological tests was administered to symptomatic subjects prior to treatment (baseline) and 90 minutes after dosing with study medication. The test battery measured vigilance as well as a broad array of cognitive functions. RESULTS: Both DL and DPH alleviated the symptoms of SAR compared to PLA (p<0.05). Treatment with DPH caused clinically meaningful decrements on all vigilance parameters (p<0.05 for DL/DPH contrasts; moderate effect sizes, ranging from .58 to .67 standard deviations). Subjects treated with DPH also performed significantly worse across all of the other cognitive domains assessed. The majority of the effect sizes for the mean DL/DPH differences were between .4 to .8 (moderate to high). The distribution of Stanford Sleepiness Scale scores also indicated significantly more sedation with DPH vs. DL or PLA (p<0.001). There was no difference in performance between subjects treated with DL and PLA on any cognitive parameter. CONCLUSION: Treatment with DL significantly improved SAR symptoms without adversely affecting cognitive performance. In contrast, DPH improved SAR symptoms but caused significant impairment of cognitive performance and significantly more sedation. Therefore, the efficacy of treatment with DPH must be balanced against the associated effects on cognitive functioning. 2 ' ~ Tecastemizole 30 mg Effectively Reduces the Symptoms of / ~ l l Allergic Rhinitis Jonathan Corren*, Paul Chervinsky§, Phillip Korenblat~, Rudolf A Baumgartner~ *Allergy Research Foundation Incorporated, Los Angeles, CA §New England Clinical Study, North Dartmouth, MA ¥St Louis University, St Louis, MO ~Sepracor incorporated, Marlborough, MA Tecastemizole (TEC) is a potent, non-sedating, once-daily antihistamine with a high affinity for the H I receptor that provides rapid and sustained relief from symptoms of allergic rhinitis. This randomized, double-blind, multicenter study evaluated the efficacy of TEC in subjects with seasonal allergic rhinitis. Subjects received placebo (PBO) or TEC 30 mg for 2 Weeks, and completed daily diary cards at 12,and 24 hours following each dose. Twelve hours after the first dose, TEC provided significant reductions in Total Symptoms Score (TSS: the sum of runny nose/postnasal drip, sneezing, itchy nose, itchy/gritty eyes, tearing/watery eyes, red/burning eyes, and ear/palate itching scores) compared with PBO (TEC LSMean1.24 over PBO, p=0.001; ie, approximately 729% over PBO). Trough TSS, measured 24 hours following the previoUs dose, was significantly decreased from baseline during the entire double-blind period (TEC LSMean -0.89 over PBO, p=0.009; ie, approximately 113% over PBO). TEC was also significantly more effective than PBO in reducing TSS, Nasal TSS, Trough Nasal TSS, Non-Nasal TSS, and Trough Non-Nasal TSS (p<0.049 for each parameter). TEC produced no significant adverse events, no change in the number or intensity of adverse events, and did not affect laboratory parameters, vital signs, or ECG results including QT intervals. Fewer TEC-treated subjects experienced sedation than PBO-treated subjects (0.5% vs 4.3%, respectively). These combined data illustrate that TEC is safe and well tolerated and provides significant allergic rhinitis symptom reduction 24 hours after dosing.