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

Phase I/II study of intranasal provocation of mite allergic rhinitis by sublingual immunization tablet dissolver.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs051230139
Enrollment
50
Registered
2023-12-01
Start date
2023-12-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

allergic rhinitis caused by mite allergic rhinitis caused by mite, nasal provocation test

Interventions

Nasal provocation by mite allergen
Nasal provocation, mite allergen

Sponsors

Imoto Yoshimasa
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
Compartment with mite allergen skin reaction

Contacts

Public ContactYoshimasa Imoto

University of Fukui Hospital

yimoto@u-fukui.ac.jp+81-776-61-8407

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026