An Optional Follow-Up Study to Evaluate the Continued Efficacy of ToleroMune Grass in Grass Allergic Subjects Following Challenge With Grass Allergen in an Environmental Exposure Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 163
- 主要终点
- Total Rhinoconjunctivitis Symptom Score
研究概览
简要总结
Grass pollen allergens are recognised as a major cause of allergic diseases in humans and animals. Worldwide, at least 40% of allergic patients are sensitised to grass pollen allergens and between 50-90% of hayfever or seasonal allergy sufferers are allergic to grass pollen. ToleroMune Grass is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of grass allergy.
The purpose of this optional observational follow-on study is to further evaluate rhinoconjunctivitis symptoms on exposure to Grass in the EEU among subjects who completed all dosing visits in study TG002 approximately one year after the start of treatment.
详细描述
Subjects who completed all dosing visits and the post treatment challenge (PTC) in study TG002 will be invited to attend the Screening Visit for TG002a. Subjects will attend for 4 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously randomised into study TG002, completed all treatment visits and PTC during calendar year 2012.
排除标准
- •"Partly controlled" and "uncontrolled" asthma
- •History of anaphylaxis to grass allergen
- •FEV1 <80% of predicted.
- •Treatment with beta-blockers, alpha-adrenoreceptor blockers, tranquilizers or psychoactive drugs
- •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 Score
时间窗: Eighteen months post first dose in TG002
次要结局
- Grass specific IgE(Eighteen months post first dose in TG002)
- Skin prick wheal diameter(Eighteen months post first dose in TG002)
- Symptom scores for nasal and non nasal symptoms(Eighteen months post first dose in TG002)
- Peak Nasal Inspiratory Flow(Eighteen months post first dose in TG002)
- Grass specific IgA(Eighteen months post first dose in TG002)
- Grass specific IgG4(Eighteen months post first dose in TG002)
- Adverse Events(Eighteen months post first dose in TG002)