NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs051230139

Registered date:01/12/2023

Development of a new diagnostic method for allergic rhinitis using mite sublingual immunization tablets

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedallergic rhinitis caused by mite
Date of first enrollment16/07/2024
Target sample size50
Countries of recruitment
Study typeInterventional
Intervention(s)Nasal provocation by mite allergen

Outcome(s)

Primary Outcome1.Percentage of positive evoked reactions based on nasal symptoms and findings 2.Safety up to 24 hours after nasal provocation test
Secondary OutcomeCompartment with mite allergen skin reaction

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum< 65age old
GenderBoth
Include criteria1. Patients with symptoms of allergic rhinitis (sneezing, watery nose, nasal congestion) . 2. Irrespective of gender 3. Patients aged 20 to 65 years at the time of consent 4. Patients who understand the contents of this study and are willing to provide written informed consent for participation in this study
Exclude criteria1. Patients with current and/or past history of bronchial asthma. 2. Patients who have previously received immunotherapy for mite allergic rhinitis. 3. Patients receiving antiallergic drugs. 4. Pregnant women and patients who may be pregnant. 5. Patients on nonselective beta-blockers. 6. Patients taking tricyclic antidepressants and monoamine oxidase inhibitors (MAOIs). 7. Patients with severe cardiac and pulmonary diseases and hypertension. 8. Patients with malignant tumors, or systemic malignancies affecting the immune system, or systemic diseases affecting the immune system 9. Patients who participated in another clinical study within 4 months. 10. Patients who are unable to take biologics withdrawal during the study period from 12 weeks prior to nasal provocation test. 11. Patients who are unable to take oral steroids withdrawal during the study period from 12 weeks prior to nasal provocation test. 12. Other patients regarded as inappropriate by the principal investigator and/or sub-investigators.

Related Information

Contact

Public contact
Name Yoshimasa Imoto
Address 23-3, Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan Fukui Japan 910-1193
Telephone +81-776-61-8407
E-mail yimoto@u-fukui.ac.jp
Affiliation University of Fukui Hospital
Scientific contact
Name Yoshimasa Imoto
Address 23-3, Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan Fukui Japan 910-1193
Telephone +81-776-61-8407
E-mail yimoto@u-fukui.ac.jp
Affiliation University of Fukui Hospital