An Optional Follow-Up Study to Evaluate the Continued Efficacy of ToleroMune HDM in House Dust Mite Allergic Subjects Following Challenge With House Dust Mite Allergen in an Environmental Exposure Chamber
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 主要终点
- Total Rhinoconjunctivitis Symptom Scores
研究概览
简要总结
House Dust Mites (HDM) are arachnids that infest bedding, carpet, upholstered furniture and fabric. Like many other allergens, exposure to HDM allergens 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 HDM is currently being developed for the treatment of HDM allergy.
The Purpose of this optional observational follow-on study is to evaluate the continued efficacy of TM-HDM in HDM allergic subjects based on change in TRSS from TH002 baseline approximately two years after the completion of the baseline EEC visit in TH002 following challenge with HDM allergen in an EEC.
详细描述
Subjects who completed all dosing visits and the post treatment challenge (PTC) in study TH002 will be invited to attend the Screening visit for TH002a. Subjects will attend for 3 visits to the EEU on successive days. Following the last EEC visit a follow-up visit will be performed 3-10 days later.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •previously randomised in study TH002, completed all dosing visits and the PTC
排除标准
- •"Partly controlled" and "uncontrolled" asthma
- •History of anaphylaxis to House Dust Mite allergen
- •FEV1 <80% of predicted.
- •Symptoms of a clinically relevant illness
- •Subjects who cannot tolerate allergen challenge in the EEC
结局指标
主要结局
Total Rhinoconjunctivitis Symptom Scores
时间窗: 2 years post after the completion of the baseline environmental exposure chamber (EEC) visit in TH002
次要结局
- Total Non Nasal Symptom Scores (TNNSS)(Two years after the completion of the baseline EEC visit in TH002)
- Der P Specific IgE(Two years after the completion of the baseline EEC visit in TH002)
- Total Nasal Symptom Scores (TNSS)(Two years after the completion of the baseline EEC visit in TH002)
- Der p Specific IgA(Two years after the completion of the baseline EEC visit in TH002)
- Der p specific IgG4(Two years after the completion of the baseline EEC visit in TH002)