Evaluation of the Efficacy of Olopatadine Hydrochloride in the Treating Allergic Rhinitis A Multicenter Randomized Double-blind Double-dummy Study

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1 CHINESE JOURNAL OF ALLERGY & CLINICAL IMMUNOLOGY # mg 2 d mg 1 d 14 d ± ± P = % 81. 4% P = % 27. 3% P = % 20. 5% R A Evaluation of the Efficacy of Olopatadine Hydrochloride in the Treating Allergic Rhinitis A Multicenter Randomized Double-blind Double-dummy Study LI Hong 1 GU Jian-qing 1 TAN Guo-lin 2 CHENG Lei 3 WANG Pei-hua 4 ZHANG Luo 5 LI Tian-ying 6 WANG De-hui 7 YIN Jia 1# Department of Allergy Peking Union Medical College Hospital Chinese Academy of Medical Sciences & Peking Union Medical College Beijing China Objective To evaluate the efficacy and safety of olopatadine hydrochloride a new antihistamine versus cetirizine hydrochloride in the treatment of allergic rhinitis. Methods A multicenter randomized double-blind double-dummy parallel-group controlled clinical trial was performed. Patients received 5 mg olopatadine hydrochloride twice per day in the study group or 10 mg cetirizine hydrochloride once time per day in the control group for 14 day. Ninety-one cases were enrolled in the study group whereas 89 cases in # doctoryinjia@ 163. com 242

2 the control group. The symptom score decreasing index was defined as primary outcome of efficacy and global efficacy and total effective rate as secondary outcome. Results The symptom score decreasing index in olopatadine hydrochloride group and cetirizine hydrochloride group were ± and ± respectively after 14 days treatment. The differences were not statistically significant P = The total effective rate was 79. 3% and 81. 4% in two groups respectively. The differences were also not statistically significant P = The adverse reaction rate were 31. 1% 27. 3% in olopatadine hydrochloride and cetirizine hydrochloride group respectively the differences were also not statistically significant P = The incidence of drowsiness was 23. 3% and 20. 5% in two groups respectively. Conclusions Olopatadine hydrochloride was effective in the treatment of allergic rhinitis. The efficacy and adverse reaction of olopatadine hydrochloride was similar to cetirizine hydrochloride. Key words olopatadine hydrochloride cetirizine hydrochloride allergic rhinitis Chin J Allergy Clin Immunol % ~ 20% 1 IgE I H1 T- regulated upon activation normal T-expressed and secreted RANTES -1 monocyte chemoattractant protein-1 MCP ~ 65 2 UniCAP sige

3 Table 1 Symptoms scoring of allergic rhinitis 5 mg 0199-A A mg mg mg mg d SSRI SSRI = * 3 ~ 5 6 ~ # 4 5 ~ 9 10 * 1 # 0 symptom score reduce index SSRI H Fig 1 Disease grades ladder diagram 244

4 2 SAS V8. 2 P SSRI ± % ~ t wilcoxon ± 95% 95% % ~ P = % SSRI ~ Pearson χ2 Fisher ± % ~ ± full analysis set FAS % ~ safety set SS SSRI FAS P = % ~ FAS P = % 70. 6% ~ % 173 FAS 60. 2% ~ FAS P = % 10. 3% ~ P = SS % 79. 3% ~ % Table 2 2 Analysis of clinical basic information n % ± n % IgE * n % + ++ ± ± ± 1. 7 n = ± ± 1. 8 n = 86 P * kua L 245

5 81. 4% ~ % P = % 95% % ~ % % 1 5 mg 2 d % 10 mg 1 d % P = % % % Table 3 3 Global efficacy of the two groups during treatments full analysis set n % n % n % n % Table 4 4 Global efficacy of the two groups after treatments full analysis set n % n % n % n % Table 5 5 Incidence of adverse drug reactions between two groups n % a b c 2. 2 n = d 1. 1 n = 88 a U L b U L c Ⅰ 1 T 1 d ST T QRS M 246

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