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

JRCT ID: jRCTs051230139

Registered date:01/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: allergic rhinitis caused by mite
• Date of first enrollment: 16/07/2024
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Nasal provocation by mite allergen

Outcome(s)

Primary Outcome

1.Percentage of positive evoked reactions based on nasal symptoms and findings
2.Safety up to 24 hours after nasal provocation test

• Secondary Outcome: Compartment with mite allergen skin reaction

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 65age old
• Gender: Both

Include criteria

1. 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 criteria

1. 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

• Primary Sponsor: Imoto Yoshimasa
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development