NCT02065856已完成2 期
An Open Trial to Assess the Tolerability of AVANZ® Salsola Immunotherapy
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Frequency of patients with adverse reactions
研究概览
简要总结
This trial is an open, national, multi-centre trial. The trial will be initiated in December 2013 and subjects will receive treatment for 6 weeks.
Safety monitoring will be performed in an ongoing basis through a Clinical Safety Group with immediate access to Adverse Events registered in the clinical database. The composition, procedures and deliverables of the Clinical Safety Group will be detailed in a Safety Agreement prior to trial start.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A clinical history of Salsola kali pollen induced allergic rhinoconjunctivitis with or without asthma at least one year prior to trial entry.
- •Positive Skin Prick Test to Salsola kali pollen (wheal diameter ≥ 3 mm).
- •Documenting in the last 5 years a positive specific Immunoglobulin E against Salsola kali pollen (≥ Class 2; ≥0.70 KU/L).
排除标准
- •Forced expiratory volume at one second 1 < 70% of predicted value at screening after adequate pharmacologic treatment.
- •Uncontrolled or severe asthma.
- •History of severe asthma exacerbation or emergency room visit or admission for asthma in the previous 12 months.
- •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).
- •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).
- •Currently treated with angiotensin converting enzyme (ACE) inhibitors, tricyclic antidepressants, β-blockers, mono amine oxidase inhibitors (MAOIs) and any other drug containing alum (e.g. antacids) taken on a daily basis.
- •Immunotherapy with Cupressus arizonica or Salsola kali pollen extracts within the previous 5 years (initiation of subcutaneous immunotherapy is acceptable if treatment has been discontinued before reaching maintenance dose; for SLIT 3 months in the last 5 years is accepted) or concomitant immunotherapy with any other allergen.
- •History of anaphylactic shock due to e.g. food, insect venom, exercise or drug.
- •History of severe and recurrent angioedema.
研究组 & 干预措施
AVANZ Salsola kali
Experimental
Subcutaneous immunotherapy
干预措施: AVANZ Salsola (Biological)
结局指标
主要结局
Frequency of patients with adverse reactions
时间窗: Participants will be followed for an expected average of 6 weeks
次要结局
- Frequency of patients with systemic reactions according to EAACI classification(Participants will be followed for an expected average of 6 weeks)
研究者
研究点 (1)
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