Cost-effectiveness of subcutaneous immunotherapy in adults with allergic rhinitis - AIRFORCE

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 240 人开始时间: 待定最近更新: 2024年5月6日

适应症

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•* 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 (RSS) >=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 (QOLs).
•Protocol exception: A sensitization for an allergen (specific IgE >=0.7 kU/l (Phadia)) is also
•considered clinically relevant and the rhinitis moderate-severe if: RSS=3 and QOLs >=3 or
•QOLs=0 and RSS >=9.
•* Signed informed consent

•* Severe/instable asthma:
•- FEV1 <=70% predicted and/or FEV1/FVC <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)

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