臨床研究等提出・公開システム

Date of registration	May. 10, 2021
Last modified on	July. 07, 2022
Trial ID	jRCT1030210077

Scientific Title	A study on systemic symptoms in patients with pollen allergy
Public Title	Systemic symptoms caused by pollen allergy

Contact for Scientific Queries	Name	Watanabe Yoshihiro
	Affiliation	Novartis Pharma. K.K.
	Address	Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan
	Telephone	+81-120003293
	E-mail	phj_medical.me_cr@novartis.com
Contact for Public Queries	Name	Direct Novartis
	Affiliation	Novartis Pharma. K.K.
	Address	Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan
	Telephone	+81-120003293
	E-mail	phj_medical.me_cr@novartis.com

Recruitment status	Not Recruiting

Anticipated date of first enrollment		April. 01, 2021
Actual date of first enrollment		April. 01, 2021
Target sample size		400
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion 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
	Exclusion 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
	Age Minimum	12age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Pollen allergy
Intervention(s)		e-Diary (weekly)
Primary Outcome(s)		the subgroup as Latent Class
Secondary Outcome(s)		the factors specifying each subgroup

Primary Sponsor	Novartis Pharma K.K.

Secondary Sponsor

Name of Certified Review Board	Medical Corporation TOUKEIKAI Kitamachi Clinic ERB
Address	1-1-3, Kitamachi, Kichijoj, Musashino-shi, Tokyo
Telephone	+81-422-22-8151
Approval Status	Approval
Date of approval	Mar. 17, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	July. 07, 2022	(this page)	Changes
1	May. 10, 2021	Detail

List of change history