EUCTR2013-001728-20-ES进行中（未招募）不适用
An open trial to assess the tolerability of AVANZ® Salsola immunotherapy
ALK-Abelló S. A.0 个研究点开始时间: 2013年9月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •1.Male and female patients 18-65 years of age.
- •2.A clinical history of Salsola kali pollen induced allergic rhinoconjunctivitis with or without asthma at least one year prior to trial entry.
- •3.Positive SPT to Salsola kali pollen (wheal diameter > 3 mm).
- •4.Documenting in the last 5 years a positive specific IgE against Salsola kali 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
排除标准
- •1.FEV1 < 70% of predicted value at screening after adequate pharmacologic treatment.
- •2.Uncontrolled or severe asthma.
- •3.History of severe asthma exacerbation or emergency room visit or admission for asthma in the previous 12 months.
- •4.At screening, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infection (serous otitis media is not an exclusion criterion).
- •5.Treatment with parenteral corticosteroids, oral corticosteroids or anti-IgE in the previous 3 months or during the study (except for steroids if needed as rescue medication).
- •6.Currently treated with angiotensin converting enzyme (ACE) inhibitors, tricyclic antidepressants, ?-blockers, mono amine oxidase inhibitors (MAOIs) and any other drug containing alum (e.g. antacids) taken on a daily basis.
- •7.Immunotherapy with Salsola kali pollen extracts within the previous 5 years
- •8.Concomitant immunotherapy with any other allergen
研究者
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