使用环境暴露舱在患尘螨过敏性鼻炎/鼻结膜炎的中国成人中评价尘螨变应原舌下片疗效及安全性的三期临床试验
[Translation] Phase 3 clinical trial evaluating the efficacy and safety of dust mite allergen sublingual tablets in Chinese adults with dust mite allergic rhinitis/rhinoconjunctivitis using an environmental exposure chamber
主要目的:与安慰剂相比,证实尘螨变应原舌下片治疗尘螨过敏性鼻炎鼻部症状(测定于第24周时EEC期间)的疗效。 关键次要目的:根据第24周时EEC期间测定的眼鼻部症状,与安慰剂相比,证实尘螨变应原舌下片治疗伴或不伴结膜炎的尘螨过敏性鼻炎的疗效。 安全性目的:在24周治疗期间,与安慰剂相比,评价尘螨变应原舌下片的安全性和耐受性。
[Translation] Main objective: To demonstrate the efficacy of dust mite allergen sublingual tablet in the treatment of nasal symptoms of dust mite allergic rhinitis (measured during EEC at week 24) compared with placebo. Key secondary objectives: To demonstrate the efficacy of the dust mite allergen sublingual tablet in the treatment of dust mite allergic rhinitis with or without conjunctivitis, compared with placebo, based on ocular and nasal symptoms measured during EEC at Week 24. Safety Objectives: To evaluate the safety and tolerability of dust mite allergen sublingual tablets compared to placebo over a 24-week treatment period.
研究SQ尘螨变应原舌下片在患尘螨过敏性鼻炎的中国成人受试者中的耐受性的随机、双盲、安慰剂对照I期试验。
[Translation] A randomized, double-blind, placebo-controlled phase I trial to study the tolerability of SQ dust mite allergen sublingual tablet in Chinese adult subjects with dust mite allergic rhinitis.
与安慰剂相比,评价12SQ-HDM剂量的SQ尘螨变应原舌下片在患尘螨过敏性鼻炎伴或不伴哮喘的中国成人受试者中的安全性和耐受性。
[Translation] To evaluate the safety and tolerability of a 12SQ-HDM dose of SQ dust mite allergen sublingual tablet compared with placebo in Chinese adult subjects with dust mite allergic rhinitis with or without asthma.
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