Evaluation of the efficacy and safety of AVANZ® Phleum pratense in grass pollen-induced allergic rhinitis during controlled exposure in an environmental challenge chamber

ALK-Abello A/S0 个研究点开始时间: 2014年3月10日最近更新: 2016年4月11日

适应症

试验速览

暂无简介。

•A documented clinically relevant history of moderate-to-severe grass pollen induced rhinoconjunctivitis with or without asthma despite having received treatment with symptom relieving medication during the previous two grass pollen seasons
•Positive SPT response (wheal diameter = 3 mm) to Phleum pratense at screening
•Positive specific IgE against Phleum pratense (= IgE Class 2; =0.70 kU/L) at screening
•Minimum level of rhinitis symptoms in an grass pollen challenge, defined as a TNSS of at least 6 (of 12) within the 3-hour grass pollen challenge at performed at the baseline ECC visit
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 130
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Rhinoconjunctivitis caused by ragweed, mugwort or Alternaria alternate, . Subjects sentised to ragweed, mugwort or Alternaria alternate are not eligible for the trial if they have symptoms induced by these allergens
•Rhinoconjunctivitis caused by animal hair and dander to which the subject is regularly exposed. Subjects sensitised to perennial allergens such as house dust mites, and moulds are not eligible for the trial if they have symptoms induced by these allergens
•Clinical history of uncontrolled asthma within 3 months prior to screening
•Subjects with reduced lung function FEV1 <70% of the predicted value after adequate pharmacologic treatment
•Subjects with asthma requiring treatment with inhaled corticosteroids outside the grass pollen seasons
•Previous treatment with immunotherapy to a grass pollen allergen or a cross-reacting allergen within the past 5 years

发起方

ALK-Abello A/S