跳至主要内容
临床试验/EUCTR2018-004205-12-SE
EUCTR2018-004205-12-SE进行中(未招募)1 期

Methylprednisolone injection in treatment of birch pollen induced allergic rhinitis

Region Skåne0 个研究点目标入组 60 人开始时间: 2018年12月17日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
Region Skåne
入组人数
60

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

性别
All

入选标准

  • - Age between 18-40.
  • - Severe seasonal birch pollen induced allergic rhinitis symptoms for birch verified by skin prick test.
  • - Signed informed consent according to IHC/GCP, and national/local regulations.
  • - Women of considered childbearing potential (WOCBP) will only be included after a negative highly sensitive pregnancy test according to CTFG recommendations.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 60
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • - Pregnancy or nursing.
  • - Autoimmune or collagen disease.
  • - Cardiovascular disease.
  • - Hepatic disease.
  • - Renal disease.
  • - Upper airway disease (non-allergic sinusitis, nasal polyposis, chronic obstructive and restrictive lung disease).
  • - Medication with a possible side-effect of interfering with the immune response.
  • - Previous immuno- or chemotherapy.
  • - Chronic disease.
  • - Major metabolic disease.
  • - Alcohol or drug abuse.
  • - Mental incapability of coping with the study.
  • - Known or suspected allergy to the study product.
  • - Suspicion of or confirmed bacterial infection.
  • - Known allergy to the study drugs, rescue medication”.

研究者

发起方
Region Skåne

相似试验