EUCTR2010-020841-29-GB进行中（未招募）1 期
The role of anti-IgE (omalizumab) in the management of severe recalcitrant paediatric atopic eczema - Atopic Dermatitis Anti-IgE Paediatric Trial (ADAPT)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 62
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
入选标准
- •The inclusion criteria for run-in are:
- •1. Children between the ages of 4-19 years at the time of enrolment
- •2. Severe eczema with
- •i.an objective SCORAD (a validated eczema severity score) of over 40
- •ii.in a patient unresponsive to optimal topical therapy (potent topical
- •steroids and topical calcineurin inhibitors) or systemic therapy.
- •iii.in whom there is no impression of lack of compliance
- •iv.with a (C)DLQI score of =10
- •v.and in whom active skin infection has been ruled out and/or adequately
- •3. Raised SpIgE (>0.35 IU/ml)or SPT (>3mm)to at least 1 food allergen
- •or 1 aeroallergen
- •4. Clinical impression that allergic exposures cause worsening eczema.
- •5. Total IgE level >300 kU/l.
- •6. Clinically proven IgE-mediated allergic disease including at least 1 of
- •the following:
- •i) immediate hypersensitivity to a food as proven by raised specific
- •IgE (SpIgE) or skin prick test (SPT) greater than the 95% positive
- •predictive value or =8mm, or a positive double blind placebo controlled
- •food challenge,
- •ii) allergic rhinoconjunctivitis as defined by sensitisation to a
- •respiratory allergen and clinical history of rhinoconjunctivitis symptoms
- •when exposed to the relevant allergen
- •iii) allergic asthma: a history of cough, wheeze, or shortness of breath
- •(1) was responsive to therapy with bronchodilators on two or
- •more occasions in the previous 24 months,
- •(2) required one visit to a physician in the previous 24 months,
- •(3) occurred during the night, during early morning, or upon
- •exercising in the intervals between exacerbations at any time in the
- •previous 12 months and
- •(4) where allergic exacerbations can be clinically related to an
- •allergen exposure WITH a corresponding positive SPT or SpIgE to
- •7. Written informed consent to participate.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 62
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 62
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Children and/or families who are unable to comply with the regime of
- •2-4 weekly injections and clinic visits
- •2. Evidence of underlying immune compromise, autioimmune disease,
- •immune complex mediated conditions.
- •3. Malignancy or a history of malignancy.
- •4. Known cardiovascular or ischaemic cerebrovascular abnormality.
- •5 Other serious or uncontrolled systemic disease.
- •6. Pregnancy or lactation.
- •7. Known history of hypersensitivity or anaphylaxis to anti-IgE injections
- •or its constituents.
- •8. Insufficient understanding of the trial assessments.
- •9. Participation in a CTIMP in the previous 60 days or (if known) 4 halflives
- •of the relevant medication, whichever is the greater. In this case,
- •entry may be delayed until the appropriate time.
- •10. Investigator feels that there is a good clinical reason why the child
- •would be unsuitable to participate in the study.
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