NCT01608243已完成1 期
Investigation of the Safety, Tolerability and Pharmacodynamic Effects of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts in Adults With House Dust Mite-associated Allergic Asthma
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Safety, tolerability as indicated by adverse events and safety laboratory evaluation
研究概览
简要总结
The purpose of this study is to investigate the safety of different doses of sublingual tablets of house dust mite allergen extracts in adults with house dust mite-associated allergic asthma.
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
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent.
- •Male or female patient from 18 to 50 years.
- •Diagnosed asthma with medical history consistent with HDM-induced allergic asthma.
- •Positive SPT to House Dust Mites(HDM)and HDM-specific IgE serum value ≥ 0.7 kU/L.
- •Stable asthma treatments.
- •Spirometry with best FEV1 > 70% of the predicted value.
- •Spirometry with reversibility of FEV1 of ≥ 12% and ≥ 200 mL.
- •Asthma Control Test™ (ACT) score ≥ 20.
排除标准
- •Current smoker or former smoker with > 10 pack/year history.
- •Co-sensitisation to any allergen possibly leading to clinically relevant respiratory allergy likely to significantly change the symptoms of the patient throughout the treatment period.
- •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.
- •Patient with any oral condition that could confound the safety assessments or planning to have a dental extraction during the study.
- •Female patient pregnant or breast-feeding/lactating.
- •Female patient of childbearing potential not using a medically accepted contraceptive method.
- •Patient treated with beta-blockers, tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs).
- •Patient who received allergen immunotherapy for HDM in the last 10 years.
- •Ongoing treatment by immunotherapy with another allergen.
研究组 & 干预措施
SLIT tablets of HDM allergen extracts
Experimental
干预措施: SLIT tablets of house dust mite allergen extracts (Biological)
Placebo
Placebo Comparator
干预措施: Matching placebo (Biological)
结局指标
主要结局
Safety, tolerability as indicated by adverse events and safety laboratory evaluation
时间窗: 10 dosing days
次要结局
未报告次要终点
研究者
研究点 (2)
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