An open trial to assess the tolerability of AVANZ® Cupressus immunotherapy

ALK-Abelló, S.A.0 个研究点开始时间: 2013年12月27日最近更新: 2015年2月16日

试验速览

暂无简介。

•Male and female aged 18-65 years.
•A documented clinically relevant history of Cupressus arizonica pollen induced allergic rhinoconjunctivitis with or without asthma for at least one year prior to trial entry.
•Positive Skin Prick Test (SPT) response to Cupressus arizonica pollen (wheal diameter ? 3 mm) .
•Documenting in the last 5 years a positive specific IgE against Cupressus arizonica pollen (? Class 2; ?0.70 KU/L).
•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 50
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•A clinical history of uncontrolled asthma within 3 months prior to screening .
•Reduced lung function (FEV1 < 70% of predicted value) after adequate pharmacologic treatment.
•History of severe asthma exacerbation or emergency room visit or admission for asthma in the previous 12 months.
•Previous treatment with immunotherapy with Cupressus arizonica pollen extract within the last 5 years Ongoing treatment with any allergen-specific immunotherapy product.
•At screening, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant process.
•A history of anaphylaxis with cardiorespiratory symptoms.
•A history of recurrent generalised urticaria during the last 2 years.
•A history of drug-induced facial angioedema or a family history of hereditary angioedema.
•Any clinically relevant chronic disease
•A systemic disease affecting the immune system.

发起方

ALK-Abelló, S.A.