A study on systemic symptoms in patients with pollen allergy

Novartis Pharma K.K.0 个研究点目标入组 400 人开始时间: 2021年4月1日最近更新: 2022年7月7日

适应症

试验速览

暂无简介。

•Written informed consent must be obtained before any assessment is performed
•12 years or older
•Mentally competent and able to communicate verbally
•Agree to provide informed consent (need assent if those are < 20 years old)
•Consent to conduct diary during the study period
•No plan to relocate to the other part of Japan (except for the neighboring prefecture) during the study period
•Fulfill one of the following criteria for each group:
•(1) For the systemic symptom group: sensitized to pollen (specific IgE >= 0.70 Ua/mL* by ImmunoCAP) and;
•a) have suffered from systemic symptoms (e.g., skin symptoms, gastrointestinal symptoms, headache, dizziness, fever, and palpitation) of pollen allergy OR
•b) have IgE-dependent food allergy caused by fruit, vegetable or soybean
•(2) For the respiratory symptom group: sensitized to pollen (specific IgE >= 0.70 Ua/mL* by ImmunoCAP) and have shown respiratory symptoms (nose, eye or cough; no systemic symptoms) of pollen allergy
•(3) For the symptom-free group: no any pollen allergy-induced symptoms regardless of sensitization

•Patients with a history of biologics use for immune disorders within one year prior to enrollment (biologic for asthma is allowed)
•Patients with chronic respiratory diseases other than asthma, heart/renal diseases, autoimmune diseases requiring medication, inflammatory bowel disease, or malignant tumors
•Patients with multiple chemical sensitivity defined by QEESI questionnaire Q1 >= 40 and Q3 >= 40
•Other patients judged to be inappropriate

the subgroup as Latent Class

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