GAP Grazax Asthma Prevention - GAP

ALK-Abelló A/S0 个研究点目标入组 620 人开始时间: 2009年8月27日最近更新: 2016年6月13日

适应症

试验速览

暂无简介。

•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: 620
•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

•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

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