A Multi-Centre, Single-Blind Study to Assess the Safety of Cat-PAD in Cat Allergic Paediatric Subjects.

Circassia Limited0 个研究点目标入组 18 人开始时间: 2014年5月21日最近更新: 2016年2月1日

适应症

试验速览

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•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
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Subjects with a history of severe drug allergy, severe angiodema or anaphylactic reaction to food.

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