A Dose Ranging Study Investigating the Efficacy and Safety of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts in Adults With House Dust Mite-associated Allergic Asthma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 386
- 试验地点
- 10
- 主要终点
- Effect on the Asthma control test (ACT) score
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of different doses of sublingual tablets of house dust mite allergen extracts as compared to placebo 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 from 18 to 50 years of age.
- •Diagnosed asthma and rhinitis with medical history consistent with HDM-induced allergic asthma and rhinitis.
- •Positive SPT to HDM and and HDM-specific IgE serum value ≥ 0.7 kU/L.
- •Stable asthma therapies.
- •Spirometry (pre-bronchodilator) with best FEV1 ≥ 70% of the predicted value.
- •Spirometry with reversibility in FEV1 of ≥ 12% and ≥ 200 mL.
- •Asthma Control Test™ (ACT) score ≤ 19.
排除标准
- •Former smoker with > 10 pack year history or current smoker.
- •Patient with a urine level of cotinine ≥ 500 ng/mL.
- •Co-sensitisation to any allergen possibly leading to clinically relevant symptoms likely to significantly change the asthma symptoms of the subject during the study.
- •Patient who received allergen immunotherapy for HDM within the past 10 years.
- •Ongoing immunotherapy for an aeroallergen other than house dust mite.
- •Patient with any oral condition that could confound the safety assessments or planning to have a dental extraction during the study.
- •Patient treated with beta-blockers, tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs).
- •Pregnant women or breast-feeding/lactating.
- •Women with childbearing potential who are not using a medically accepted birth control method.
- •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.
研究组 & 干预措施
SLIT (A)
SLIT tablets of HDM allergen extracts, 3 different doses (A)
干预措施: SLIT tablets of HDM allergen extracts, 3 different doses (A) (Biological)
SLIT (B)
SLIT tablets of HDM allergen extracts, 3 different doses (B)
干预措施: SLIT tablets of HDM allergen extracts, 3 different doses (B) (Biological)
SLIT (C)
SLIT tablets of HDM allergen extracts, 3 different doses (C)
干预措施: SLIT tablets of HDM allergen extracts, 3 different doses (C) (Biological)
Placebo
Placebo matching the SLIT tablets of HDM allergen extracts
干预措施: Placebo matching the SLIT tablets of HDM allergen extracts (Biological)
结局指标
主要结局
Effect on the Asthma control test (ACT) score
时间窗: 13 months
Assessment of the effect of one year of treatment of 3 different doses of sublingual immunotherapy tablets of house dust mite (HDM) allergen extracts as compared to placebo on the Asthma Control Test™ (ACT) score, in adults with HDM-associated allergic asthma
次要结局
- Number and percentage of subjects with treatment-emergent AEs(Measured during 13 months)