A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Parallel-Group Study to Assess the Tolerability of ToleroMune House Dust Mite in Subjects With Controlled Asthma and House Dust Mite-Induced Rhinoconjunctivitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Adverse Events
研究概览
简要总结
House Dust Mites (HDMs) are arachnids that infest bedding, carpet, upholstered furniture and fabric. Like many other allergens, exposure to HDMA in sensitised patients is associated with poorer lung function, greater medication requirements and more asthma symptoms as well as chronic rhinosinusitis symptoms. In contrast to other allergens, there is evidence that HDMA leads to the development of asthma, in addition to exacerbating pre-existing asthma in HDM-sensitised patients.
ToleroMune House Dust Mite (TM-HDM), a combination of seven Synthetic Peptide Immuno-Regulatory Epitopes, is being developed for the treatment of HDM allergy.
This study to assess the tolerability of ToleroMune House Dust Mite in subjects with controlled asthma and house dust mite-induced rhinoconjunctivitis.
详细描述
A multi-centre, randomised, double-blind, placebo-controlled, parallel-group, multiple dose study to evaluate the tolerability of four intradermal doses of TM-HDM in subjects with controlled asthma and HDM-induced rhinoconjunctivitis.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 18-65 years.
- •Asthma controlled by Step 1 or Step 2 treatment as defined by GINA in the four weeks prior to randomisation.
- •Asthma controlled by Step 1 or Step 2 treatment as defined by GINA in the four weeks prior to randomisation.
- •No change in asthma controller treatment (dose, frequency) in the four weeks prior to randomisation.
- •A reliable history consistent with rhinoconjunctivitis on exposure to HDM for at least 1 year that has required symptomatic treatment on at least one occasion during the year prior to randomisation
- •Positive skin prick test to Dermatophagoides pteronyssinus with an average wheal diameter at least 5 mm larger than that produced by the negative control.
- •ImmunoCAP® Dermatophagoides pteronyssinus-specific Immunoglobulin E ≥ 0.35 kU/L.
排除标准
- •History of life-threatening asthma
- •Asthma exacerbation in the 12 weeks prior to randomisation
- •Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) < 80 % of predicted, regardless of the cause.
- •Post-bronchodilator FEV1/Forced Vital Capacity ratio of < 0.
- •Concurrent respiratory disease that would confound study participation or affect subject safety.
- •Non-HDM allergy that may significantly interfere with the results of this study.
- •Previous immunotherapy treatment with any HDM allergen for more than 1 month within 5 years prior to screening.
结局指标
主要结局
Adverse Events
时间窗: Up to 19 Weeks
次要结局
- Peak Expiratory Flow Rate(Up to 19 Weeks)
- VAS Breathlessness(Up to 19 weeks)
- Asthma Exacerbations(Up to 19 weeks)
- Systemic Allergic Reactions(Up to 19 Weeks)
- FEV1 and FVC(Up to 19 Weeks)
- Injection Site Examinations(Up to 19 Weeks)