Systemic symptoms caused by pollen allergy

JRCT ID: jRCT1030210077

Registered date:10/05/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Pollen allergy
• Date of first enrollment: 01/04/2021
• Target sample size: 400
• Study type: Interventional
• Intervention(s): e-Diary (weekly)

Outcome(s)

• Primary Outcome: the subgroup as Latent Class
• Secondary Outcome: the factors specifying each subgroup

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Written informed consent must be obtained before any assessment is performed
2. 12 years or older
3. Mentally competent and able to communicate verbally
4. Agree to provide informed consent (need assent if those are < 20 years old)
5. Consent to conduct diary during the study period
6. No plan to relocate to the other part of Japan (except for the neighboring prefecture) during the study period
7. 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

Exclude criteria

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

Related Information

• Primary Sponsor: Watanabe Yoshihiro