Tokyo, July 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058457) titled 'What factors influence the effectiveness of cedar pollinosis immunotherapy?' on July 20.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Non-randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Nippon Medical School

Condition: Condition - Japanese cedar pollinosis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The aim of this study is to elucidate the factors influencing the efficacy of sublingual immunotherapy. By clarifying the differences in efficacy between children and adults, the aim is to establish guidelines to determine whether sublingual immunotherapy is indicated in the pre-treatment phase for hay fever patients of all ages. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - For the immunotherapy group, cedar pollen allergy patients with positive serum cedar pollen-specific IgE, aged 5 years and over who opted for treatment with Cidacure cedar pollen sublingual tablets. Interventions/Control_2 - For the drug treatment group, cedar pollen allergy patients with positive serum cedar pollen-specific IgE, aged 5 years and over, who opted for treatment with a therapeutic agent other than sublingual immunotherapy.

Eligibility: Age-lower limit - 5 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. for the immunotherapy group, cedar pollen allergy patients with positive serum cedar pollen-specific IgE, aged 5 years and over who opt for treatment with Cidacure cedar pollen sublingual tablets 2. for the drug treatment group, cedar pollen allergy patients with positive serum cedar pollen-specific IgE, aged 5 years and over who opted for treatment with a therapeutic agent other than sublingual immunotherapy 3. for the control group, non-allergic rhinitis patients with negative serum IgE antibodies, aged 15 years and over who are continuing in-patient treatment for symptom relief 4. those who have been informed about the study using the consent document and have given their consent. Key exclusion criteria - 1. persons who have developed allergic symptoms as a result of diagnosis or treatment with allergen extracts or consumption of foods containing cedar pollen 2. persons who currently suffer from bronchial asthma . 3. persons with malignant tumours or systemic diseases affecting the immune system. 4. persons with wounds or inflammation in the oral cavity or after oral surgery such as tooth extraction 5. persons on non-selective beta-blockers 6. persons on tricyclic antidepressants and monoamine oxidase inhibitors 7. persons with severe cardiac or pulmonary disease and hypertension 8. persons receiving systemic steroids 9. pregnant or lactating women 10. persons with a history or illness that adversely affects immunotherapy 11. any other person who is deemed by the principal investigator or a research partner to be unsuitable to participate in this study. Target Size - 150

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2024 Year 09 Month 06 Day Anticipated trial start date - 2025 Year 10 Month 01 Day Last follow-up date - 2026 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066844

Disclaimer: Curated by HT Syndication.