Investigation of the Safety and Tolerability of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts in Adolescents With House Dust Mite-associated Allergic Rhinitis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Safety and Tolerability Evaluated on Treatment Emergent Adverse Events
研究概览
简要总结
The purpose of this study is to investigate the safety and tolerability of different doses of sublingual tablets of house dust mite (HDM) allergen extracts in adolescents with house dust mite-associated allergic rhinitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent from patient and parent(s)/legal representative.
- •Male or female patient from 12 to 17 years.
- •Diagnosed rhinitis with medical history consistent with HDM-induced allergic rhinitis for at least 1 year before visit 1
- •Positive Skin Prick Test to House Dust Mites(HDM)and HDM-specific IgE serum value ≥ 0.7 kUnit/L.
- •Concommittant controlled asthma allowed up to GINA 1 or 2 treatment step
- •Spirometry with best FEV1 > 80% of predicted FEV1.
排除标准
- •Patient with a nasal or oral disease that could interfere with the safety assessments
- •Patient has undergone recent nasal surgery
- •Patient with asthma receiving therapy consistent with GINA (Global INitiative for Asthama) treatment step 3, 4, or
- •Patient with partially controlled or uncontrolled asthma
- •Patient with a past or current disease, which as judged by the Investigator, may affect the patient's participation in or the outcome of this study.
- •Female patient pregnant or breast-feeding/lactating.
- •Female patient of childbearing potential planning a pregnancy during this trial or not using a medically accepted contraceptive method.
- •Patient treated with beta-blockers, tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs).
- •Patient who received allergy specific immunotherapy for house dust mites for more than 1 month in the 5 years before screening or who is currently receiving immunotherapy with any allergen.
- •patient with a history of anaphylaxis
- •patient having participated in any clinical study within the 12 weeks before visit 1
研究组 & 干预措施
500 IR
500 IR house dust mites allergen extract tablet
干预措施: 500 IR house dust mites allergen extract tablet (Biological)
1000 IR
1000 IR house dust mites allergen extract tablet
干预措施: 1000 IR house dust mites allergen extract tablet (Biological)
1500 IR
1500 IR house dust mites allergen extract tablet
干预措施: 1500 IR house dust mites allergen extract tablet (Biological)
Placebo
Placebo tablet
干预措施: Placebo tablet (Biological)
结局指标
主要结局
Safety and Tolerability Evaluated on Treatment Emergent Adverse Events
时间窗: 10 dosing treatment days
Safety and tolerability evaluated on the number of participants who reported at least one treatment-emergent adverse event (TEAE)
次要结局
- Treatment Emergent Serious Adverse Events(10 dosing treatment days)
- Adverse Events Leading to Study Withdrawal(10 dosing treatment days)