跳至主要内容
临床试验/EUCTR2009-011827-30-NL
EUCTR2009-011827-30-NL进行中(未招募)不适用

Cost-effectiveness of subcutaneous immunotherapy in adults with allergic rhinitis. - Cost-effectiveness of SCIT in allergic rhinitis

ErasmusMC-University Medical Center Rotterdam0 个研究点开始时间: 2009年4月8日最近更新:
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

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

  • * 18-45 years
  • * Clinically relevant moderate to severe allergic rhinitis due to a sensitization for
  • one, two or three of the following allergens: tree pollen (TP), grass pollen (GP)
  • and/or house dust mite (HDM). For each allergen (TP, GP, HDM) the following 3
  • criteria are evaluated. A sensitization for an allergen is considered clinically
  • relevant and the rhinitis moderate-severe if:
  • 1) specific IgE =0.7 kU/l (Phadia)
  • 2) retrospective total symptom score =4: participants will score 4 nose
  • symptoms (sneezing, itching nose, watery running nose, nasal blockage)
  • during the previous peak exposure period (TP April 1-May 15; GP May
  • 15-June 30; HDM September 1-October 31) on a 0-3 scale (0=none, 1=mild,
  • 2=moderate, 3=severe; maximum total score=12).
  • 3) the presence of =1 of the following complaints due to rhinitis during the
  • previous season: sleep disturbance; impairment of daily activities; leisure
  • and/or sport; impairment of school or work; troublesome symptoms.
  • * Signed informed consent
  • 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
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • * Severe/instable asthma:
  • - FEV1 =70%
  • - Asthma exacerbation requiring prednisolon treatment, visit to a first aid station
  • and/or hospitalisation in the preceding 12 months.
  • * Specific IgE = 0.7 kU/l to animals the patient is in daily contact with
  • * Immunotherapy in preceding 5 years
  • * Anatomical disorders of the nose
  • * Language barrier
  • * No daily access to internet (because of web based questionnaires)
  • * Contraindications to immunotherapy (according to international guidelines; i.e.
  • history of anaphylaxis; immunosuppressive treatment etc)

研究者

发起方
ErasmusMC-University Medical Center Rotterdam

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