drugset / Trial / NCT07436208

Serum sST2/ miR-223 as a Dual Biomarker for Disease Activity & Clinical Efficacy of SLIT in HDM-Induced Allergic Rhinitis

NCT07436208 ↗

Phase 1 Completed 54 enrolled Zagazig University
NaSingle-groupOpen-labelTreatment

Summary

Soluble suppression of tumorigenicity 2 (sST2), a decoy receptor of interleukin-33 (IL-33), involved in allergic inflammation. Objectives: This study explored serum sST2 as a biomarker for disease activity and for predicting clinical response to sublingual immunotherapy (SLIT) in patients with house dust mite (HDM) induced AR. Methods: This study included 54 patients with moderate-to-severe AR (MSAR) and 54 healthy controls (HC). Serum sST2, total IgE, HDM-specific IgE, and eosinophil counts were measured. Serum levels of miR-223 were assayed using real-time PCR. Clinical severity was assessed using the total nasal symptom score (TNSS) and visual analogue scale (VAS). MSAR patients received SLIT for 6 months. Treatment response was defined by ≥30% reduction in symptom and medication scores.

Timeline

Start
2025-02-01
Primary completion
2025-05-30
Completion
2025-11-30

Publications

  • Results Bousquet , J., Agache, I., Aliberti, M.R., Anguelova-Fischer, D., Bachert, C., Bedbrook, A., et al. (2020). Next-generation Allergic Rhinitis and Its Impact on Asthma (ARIA) guidelines for allergic rhinitis based on GRADE and real-world evidence. Journal of Allergy and Clinical Immunology, 145(1), 70-80.e3. https://doi.org/10.1016/j.jaci.2019.06.049 - Tamasauskiene , L., Gasiuniene, E., Sitkauskiene, B. (2021). Translation, adaption and validation of the total nasal symptom score (TNSS) for Lithuanian population. Health and Quality of Life Outcomes, 19(1), 54. https://doi.org/10.1186/s12955-020-01659-8 - Lote, S., Gupta, S.B., Poulose, D., et al. (2022). Role of the skin prick test in urticaria patients. Cureus, 14(2), e21818. https://doi.org/10.7759/cureus.21818 - Klangkalya , N., Kanchongkittiphon, W., Sawatchai, A., Kiewngam, P., Jotikasthira, W., Manuyakorn, W. (2024). Skin prick test and serum specific IgE in predicting dust mite-induced allergic rhinitis diagnosed from nasal provocation test in chronic rhinitis children. Asian Pacific Journal of Allergy and Immunology, 42(4), 354-360. https://doi.org/10.12932/AP-010822-1422. - Jeffries J, Zhou W, Hsu AY, et al. (2019). miRNA- 223 at the crossroads of inflammation and cancer. Cancer Letter. 451:136-141.

Drugs

EvaluationDrugModalityDoseRoute
Subject HDM extracts Unknown — Subcutaneous

Indications