EUCTR2014-000279-15-PL
进行中（未招募）
不适用
A Multi-Centre, Single-Blind Study to Assess the Safety of Cat-PAD in Cat Allergic Paediatric Subjects.
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Treatment of cat-allergen induced rhinoconjunctivitis in paediatric subjects with clinically relevant symptoms
- 发起方
- Circassia Limited
- 入组人数
- 18
- 状态
- 进行中（未招募）
- 最后更新
- 10年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Male or female, aged 5 to \<12 years.
- •2\. A reliable history consistent with moderate to severe rhinoconjunctivitis (sneezing, rhinorrhoea, itchy nose, nasal blockage and/or itchy eyes, red eyes, sore eyes, watering eyes) on exposure to cats for at least 2 years and which has required symptomatic treatment on at least one occasion during the last year.
- •\- Subjects may also have asthma controlled using reliever medication as defined in GINA.
- •3\. Subjects who live in a home with a cat that spends, on average, a minimum of 8 hours per day inside.
- •4\. Positive skin prick test to cat hair allergen with a wheal diameter (mean of longest and orthogonal diameter) at least 5 mm larger than that produced by the negative control.
- •5\. A cat dander specific Immunoglobulin E (IgE) \=0\.35 kU/L.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 18
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range
排除标准
- •1\. Subjects with a history of severe drug allergy, severe angiodema or anaphylactic reaction to food.
结局指标
主要结局
未指定
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