NCT01568190已完成2 期
An Open Trial to Asses the Tolerability of AVANZ Mite Mix Immunotherapy
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Frequency of patients with adverse reactions.
研究概览
简要总结
The purpose of the trial is to assess the tolerability of the up-dosing phase of AVANZ Mite mix.
详细描述
The frequency of patients with adverse reactions will be the primary endpoint.
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 HDM induced allergic rhinoconjunctivitis with or without asthma at least one year prior to trial entry.
- •Positive SPT to Dermatophagoides pteronyssinus (Der pte) or Dermatophagoides farinae (Der far) (wheal diameter ≥ 3 mm).
- •A positive specific IgE against Der pte or Der far (≥Class 2; ≥0.70 KU/L) documenting in the last 5 years.
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). Please, see Table
- •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 HDM 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 wil be followed for an expected average of 6 weeks.
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 wil be followed for an expected average of 6 weeks.)
研究者
研究点 (2)
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