EUCTR2009-011235-12-FI进行中（未招募）1 期
GAP Grazax Asthma Prevention - GAP
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 812
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Females and males 5-12 years of age at time of randomisation
- •Written informed consent obtained from parents/guardians
- •Assent from subject, according to national guidelines
- •A clinical relevant history of grass pollen induced allergic rhino-conjuctivitis having received symptomatic treatment during the GPS 2009 and 2010,
- •Positive Skin Prick Test (SPT) reponse (wheal diameter = 3 mm) to Phleum pratense
- •Positive specific IgE against Phleum Pratense (= IgE Class 2)
- •Female subjects, who are fertile must have a negative pregnancy test
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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
排除标准
- •A clinical relevant history of symptomatic seasonal allergic rhinitis and/or conjunctivitis caused by an allergen other than grass overlapping the GPS.
- •A clinical relevant history of symptomatic perennial allergic rhinitis and/or conjuctivitis caused by an allergen, to which the subject is regularly exposed.
- •Not capable of perfoming reproducible lung function tests
- •A medical history of astma and/or wheezing within the last two years.
- •A medical hsiotry of asthma and/or wheezing since the 5th birthday.
- •Use of asthma medication within the last 12 month, to treat respiratory and/or pulmonary symptoms which resulted in a clinical relevant effect.
- •An increase in FEV-1 of = 12% after administration of a beta-2-agonist
- •Investigator diagnosed asthma
- •Diurnal PEF variability > 20% for at least 3 out of 14 consecutive days
研究者
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