NCT02075138已完成不适用
An Observational Multi-Centre Field Study to Assess Symptom Scores and Allergy Medication Usage in Subjects With a History of Grass-Induced Rhinoconjunctivitis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 主要终点
- To evaluate Total Rhinoconjunctivitis Symptom Score and allergy medication use as a combine score
研究概览
简要总结
Grass pollen allergens are universally recognised as a major cause of allergic diseases in humans, including asthma, allergic rhinitis, conjunctivitis and dermatitis.
The purpose of the current study is to evaluate allergy symptoms and allergy medication in subjects with grass-related rhinoconjunctivitis.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of moderate to severe rhinoconjunctivitis consistent with allergy to grass for at least 2 years.
- •Forced Expiratory Volume in 1 Second (FEV1) of at least 70% of predicted value or personal best if available at the Screening Visit.
- •Perennial Rye grass or Timothy grass-specific IgE ≥ 0.35 kU/L as measured by ImmunoCAP®.
- •Positive skin prick test to Perennial Rye grass or Timothy grass allergen
排除标准
- •Positive skin prick test ≥ 5 mm to any confounding, co-existing seasonal allergens likely to be present during the pre-season baseline and grass pollen period.
- •Medical records of symptomatic perennial allergic rhinitis and/or asthma or a positive skin test ≥ 5 mm due to a perennial allergen to which the subject is regularly exposed (moulds, dust mites, cockroaches, and animal dander) and which cannot be avoided during the course of the study.
- •Previous immunotherapy treatment with any grass allergen for more than 1 month within 5 years prior to screening.
- •Subjects who had been treated with any non-grass licensed allergen immunotherapy extracts or non-grass investigational immunotherapy for more than 1 month within 1 year.
结局指标
主要结局
To evaluate Total Rhinoconjunctivitis Symptom Score and allergy medication use as a combine score
时间窗: 6 weeks
次要结局
未报告次要终点
研究者
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