An Optional Two Year Follow Up Study to Evaluate the Continued Efficacy of Cat-PAD ToleroMune Peptide Immunotherapy in Cat Allergic Subjects Following Challenge to Cat Allergen in an Environmental Exposure Chamber
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Total Rhinoconjunctivitis Symptom Score
研究概览
简要总结
Cat allergy is an increasingly prevalent condition affecting 10-15% of patients with allergic rhinoconjunctivitis and/or asthma.
The purpose of this optional observational follow-on study is to further evaluate rhinoconjunctivitis symptoms on exposure to cat dander in the EEC among subjects who completed all dosing visits in study CP005 and all visits in study CP005A approximately two years after the start of treatment.
详细描述
Subjects who completed all visits in studies CP005 and CP005A will be invited to attend the Screening Visit for CP005B. Subjects will attend for 4 visits to the EEC on successive days. Following the last EEC visit is a follow-up visit which 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 CP005 and completed all visits in the follow-on study CP005A
排除标准
- •"Partly controlled" and "uncontrolled" asthma
- •History of anaphylaxis to cat allergen
- •Subjects with an FEV1 < 70% of predicted
- •Subjects who cannot tolerate baseline challenge in the EEC
- •Treatment with beta-blockers, alpha-adrenoceptor blockers, tranquilizers, or psychoactive drugs
- •Symptoms of a clinically relevant illness, in the Investigator's opinion, within 6 weeks prior to Screening Visit
结局指标
主要结局
Total Rhinoconjunctivitis Symptom Score
时间窗: 102-106 weeks after the start of treatment in CP005
次要结局
- Total Symptom scores for ocular and nasal symptoms(102-106 weeks after the start of treatment in CP005)