ISRCTN67316358已完成2 期
A multicentre randomised placebo-controlled double-blind clinical trial for the evaluation of efficacy of specific immunotherapy (SIT) with an aluminium hydroxide-adsorbed recombinant hypoallergenic derivative of the major birch pollen allergen r Bet v1-FV on Bet v 1 associated soy allergy
niversity of Leipzig (Germany)0 个研究点目标入组 56 人开始时间: 2009年8月27日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
研究概览
简要总结
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/27998002 (added 08/08/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male or female adult patients aged 18 - 65 years inclusive, legally competent
- •2. Informed consent
- •3. History of spring pollinosis for at least 2 years
- •4. Sensitisation to birch pollen as demonstrated by positive SPT to birch (wheal greater than 3 mm)
- •5. Specific IgE for Bet v 1 and Gly m4 (both greater than ImmunoCAP class 1
- •6. Clinical relevance of Gly m4 sensitization as demonstrated by positive food challenge (DBPCFC) to soy proteins
- •7. For female patients: effective contraception and negative pregnancy test result
排除标准
- •1. SIT against birch within last 5 years
- •2. Pregnancy, lactation period or female patients seeking to become pregnant
- •3. Peak expiratory flow (PEF) or forced expiratory volume in one second (FEV1) less than 80% of predicted normal (ECCS) or
- •4. Uncontrolled bronchial asthma according to Global Initiative for Asthma (GINA) 2006
- •5. Febrile infections or inflammation of the respiratory tract at the time of inclusion
- •6. Irreversible secondary lung alterations (i.e. emphysema, bronchiektasia)
- •7. Severe acute or chronic diseases, severe inflammatory diseases
- •8. Other severe generalised diseases (liver, heart, kidney, metabolic disorders)
- •9. Autoimmune diseases, immune defects including immunosuppression, immune-complex induced immunopathies
- •10. Severe psychiatric and psychological disorders including impairment of cooperation (e.g. alcohol or drug abuse)
- •11. Completed or ongoing long-term treatment with tranquilizer or psycho-active drugs
- •12. Short time therapy with oral glucocorticosteroids is possible under certain circumstances
- •13. Concurrent participation in any other clinical trial or participation in any other clinical trial during the previous 30 days
- •14. Low compliance or inability to understand instructions/study documents
- •15. Patients who have been committed to a mental hospital by government or court
- •16. Completed or ongoing treatment with anti-IgE antibody
- •17. Patients being in any relationship or dependence with the sponsor and/or investigator
- •18. Contraindication for adrenaline, (e.g. acute or chronic symptomatic coronary heart disease, severe arterial hypertension)
- •19. Therapy with betablockers topically or systemically
- •20. Patient's withdrawal of consent
研究者
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