ISRCTN15090567已完成未知
The role of anti-IgE (omalizumab) in the management of severe recalcitrant paediatric atopic eczema
Guy's & St Thomas' NHS Foundation Trust & King's College London (Comprehensive)0 个研究点目标入组 62 人开始时间: 2014年12月3日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 62
研究概览
简要总结
2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28330497 2017 statistical analysis plan in: https://www.ncbi.nlm.nih.gov/pubmed/28535776 2020 results in https://pubmed.ncbi.nlm.nih.gov/31764962/ (added 07/08/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Children between the ages of 4-19 years at the time of enrolment into the trial
- •2. Severe eczema with
- •2.1. an objective SCORAD (a validated eczema severity score) of over 40
- •2.2. in a patient unresponsive to optimal topical therapy (potent topical steroids and topical calcineurin inhibitors)
- •2.3. in whom there is no impression of lack of compliance
- •2.4. with a (C)DLQI score of =10
- •2.5. and in whom active infection has been ruled out and/or adequately treated
- •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:
- •6.1. 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,
- •6.2. Allergic rhinoconjunctivitis as defined by sensitisation to a respiratory allergen and clinical history of rhinoconjunctivitis symptoms when exposed to the relevant allergen
- •6.3. Allergic asthma: a history of cough, wheeze, or shortness of breath that
- •6.3.1. Was responsive to therapy with bronchodilators on two or more occasions in the previous 24 months
- •6.3.2. Required one visit to a physician in the previous 24 months
- •6.3.3. Occurred during the night, during early morning, or upon exercising in the intervals between exacerbations at any time in the previous 12 months
- •6.3.4. Where allergic exacerbations can be clinically related to an allergen exposure WITH a corresponding positive SPT or SpIgE to allergen
- •7. Written informed consent to participate.
排除标准
- •1. Children and/or families who are unable to comply with the regime of 24 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. Preexisting hepatic or renal impairment
- •5. Known cardiovascular or ischaemic cerebrovascular abnormality
- •6. Other serious or uncontrolled systemic disease
- •7. Pregnancy or lactation
- •8. Known history of hypersensitivity or anaphylaxis to anti-IgE injections or its constituents
- •9. Insufficient understanding of the trial assessments
- •10. Participation in a CTIMP in the previous 60 days or (if known) 4 half-lives of the relevant medication, whichever is the greater. In this case, entry may be delayed until the appropriate time
- •11. Investigator feels that there is a good clinical reason why the child would be unsuitable to participate in the study
研究者
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