Artemisia Annua sublingual immunotherapy for seasonal allergic rhinitis: A multicenter, randomized trial

Autor: Hongfei Lou, Xueyan Wang, Qingyu Wei, Changqing Zhao, Zhimin Xing, Qinna Zhang, Juan Meng, Shaoqiang Zhang, Huifang Zhou, Ruixia Ma, Hua Zhang, Hui Liu, Weiguo Xue, Chengshuo Wang, Luo Zhang
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Zdroj: World Allergy Organization Journal, Vol 13, Iss 9, Pp 100458- (2020)
Druh dokumentu: article
ISSN: 1939-4551
DOI: 10.1016/j.waojou.2020.100458
Popis: Background: Artemisia annua is the most common outdoor aeroallergen throughout Northern China; however, no multicenter study has investigated sublingual immunotherapy (SLIT) as a treatment option for Artemisia annua-induced allergic rhinitis (AR). The aim of this study was to evaluate the efficacy and safety of an innovative SLIT for Artemisia annua-related AR. Methods: This was a randomized, double-blind, placebo-controlled, multicenter, phase 3 clinical trial conducted in China (NCT XXX). A total of 702 Artemisia annua-sensitized eligible patients were randomized in a ratio of 2:1 to receive Artemisia annua-SLIT or placebo. The treatment lasted 32 weeks; including 5-weeks up-dosing phase and 27-weeks maintenance phase. The primary endpoint was the daily combined score of medication and rhinoconjunctivitis symptom (CSMRS), and secondary endpoints were daily total nasal symptom score (dTNSS) and daily rescue medication score (dRMS) during peak pollen period. Safety of treatment was evaluated according to adverse events (AEs) experienced. Results: Mean daily CSMRS was significantly improved during the peak pollen period in the SLIT group compared with the placebo group (1.46 ± 0.47 vs 1.88 ± 0.42, P
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