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
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