EUCTR2009-015679-28-GB进行中（未招募）1 期
PRIMARY PREVENTION OF ATOPY AND ASTHMA WITH ALLERGEN SUBLINGUAL IMMUNOTHERAPY - Mite allergy prevention study (MAPS)
Southampton University Hospitals Trust0 个研究点目标入组 120 人开始时间: 2010年3月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
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
入选标准
- •Inclusion Criteria: Infants aged 5 to 9 months at high risk of development of asthma and atopy, as defined by two or more first degree relatives (i.e. biological mother, father or sibling) affected by asthma or allergy, assessed through standardised questionnaires.
- •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
- •Infants with positive skin test to one or more of 6 common allergens (house dust mite, grass pollen, cat, cows’ milk, egg white and peanut), prior to randomization at the age of 6-9 months, will be excluded. Following initial agreement and consent of the parents, skin prick test will be performed (in duplicate for house dust mite), on the volar surface of the forearm of the infant, using standardised methodology. A mean wheal diameter of =3mm when compared with saline control will be regarded as positive, the infant will be considered sensitized and excluded from the study. Infants with major concurrent health problems (e.g. congenital heart disease, cystic fibrosis, those requiring special feeding regimens on account of prematurity or illness) will be also be excluded.
研究者
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