NCT01674595已完成2 期
An Open Trial to Assess the Tolerability of AVANZ Olive Immunotherapy
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 2
- 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 after olive pollen season 2012 and subjects will receive treatment for 6 weeks.
The aim of study is to assess the tolerability of the up-dosing phase of AVANZ Olive. The frequency of patients with adverse reactions will be the primary endpoint.
Frequency of patients with systemic reactions according to EAACI classification, increase in IgG4 and in IgE and reduction in immediate skin reactivity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Male and female patients 18-65 years of age.
- •A clinical history of olive pollen induced allergic rhinoconjunctivitis with or without asthma at least one year prior to trial entry.
- •Positive SPT to olive pollen (wheal diameter ≥ 3 mm).
- •A positive specific IgE against olive pollen (≥Class 2; ≥0.70 KU/L) documented in the last 5 y
排除标准
- •FEV1 < 70% of predicted value at screening after adequate pharmacologic treatment.
- •Uncontrolled or severe asthma.
- •A clinically relevant history of symptomatic perennial allergic rhinitis and/or conjunctivitis caused by an allergen to which the subject is regularly exposed and sensitized.
- •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.
- •Previous treatment by other allergen concomitant IT or immunotherapy with Olea europaea 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).
- •History of anaphylactic shock due to e.g. food, insect venom, exercise or drug.
- •History of severe and recurrent angioedema.
- •Any contraindication according to the Investigator Brochure (IB).
- •Use of an investigational drug within 30 days prior to screening.
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 week.s
From date of inclusion until date of last visit documented, it's expected an average of 6 visits, assessed up to 6 weeks per subject.
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 (2)
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