NL-OMON30665已完成3 期
Twin SUBLIVAC® Grasses Clinical Efficay Study - niet van toepassing
HAL Allergenen Lab0 个研究点目标入组 25 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 12 至 99(—)
入选标准
- •Subjects with allergic rhinoconjunctivitis with or without mild asthma (FEV1 >= 70%) for at least 2 years. Their allergic symptoms should be related to grass pollen
- •Use of anti-allergy symptomatic medication in the last pollen season (or, in case of a low pollen season, in one of the two previous years)
- •A positive skin prick test (>3 mm) for grasses and specific serum IgE-test
- •(>1 U/ml) for grass pollen (Lolium perenne, Phleum pratense and Poa pratensis).
- •Age 12 years or older.
- •Subjects (and their parents if required) shall give a written informed consent
排除标准
- •A positive SPT for perennial allergens of house dust mite
- •Symptoms related to concomitant sensitisation to perennial allergens of pets
- •Chronic asthma or emphysema, particularly with a FEV1 < 70 % of predicted value or use of inhalation corticosteroids outside grass and tree pollen season for more than two episodes and/or longer than fourteen days
- •Use of symptomatic medication for more than three episodes and/or longer than three days outside the tree- or grasspollen season
- •Serious immuno-pathological diseases or malignancies (including auto-immune diseases, tuberculosis, HIV)
- •Inflammation and infection of the target organ
- •Severe atopic dermatitis requiring systemic immuno-suppressive medication
- •Allergen specific immuno-therapy treatment within the last 5 years for a period longer than three months
研究者
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