Intratonsillar Immunotherapy for Allergic Rhinitis
NCT Number: NCT06523478
Acronym: ITITFAR
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Allergic Rhinitis
Interventions: PROCEDURE: Intratonsillar immunotherapy (ITIT)|PROCEDURE: Subcutaneous immunotherapy (SCIT)
Sponsor: Xu Yu
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-04-29
Completion Date: 2028-04-29
Locations: Renmin Hospital of Wuhan University, Wuhan, Hubei, 430060, China

Summary:
This is a prospective, open-label, positive parallel controlled, blinded endpoint clinical study designed to compare the safety and efficacy of "Intratonsillar Immunotherapy of Standardized Dust Mite Allergen Extracts (Novo Helisen-Depot, Allergopharma, Merck, Germany)" with Subcutaneous Immunotherapy in patients with "Dust Mite Allergic Rhinitis."

Participants will be evaluated for safety and efficacy throughout the entire three-year period.

Primary Outcome Measures: Combined Symptom and Medication Score (CSMS), Combined Symptom and Medication Score (CSMS) serves as the primary efficacy endpoint, tracking changes in participant symptoms and assessing the sustainability and stability of treatment effects. It comprises:

Allergen-induced symptom score: Scored from 0 (no symptoms) to 3 (most severe symptoms) for nasal congestion, rhinorrhea, nasal itching, sneezing, eye itching, and tearing, with the average yielding the symptom score (SS).

Emergency medication use related to allergy symptoms: Assigned points based on antihistamine (1 point/day), nasal corticosteroid (2 points/day), and oral corticosteroid (3 points/day) usage, with the highest value determining the medication score (MS).

CSMS (0-6) = SS (0-3) + MS (0-3). Recorded at baseline and 1, 2, 3, 6, 12, 24, and 36 months post-dust mite extract treatment., Pre-intervention screening period; 3 months, 6 months, 12 months, 24 months, 36 months after the first intervention. Up to 36 months|Number of Participants with Local or Systemic Adverse Reactions, Participants will be observed for 30 minutes post-injection and encouraged to report any adverse events during follow-up. Adverse reactions are classified as local reaction (LR) or systemic reaction (SR) according to the World Allergy Organization Subcutaneous Immunotherapy Response Classification System. Detailed records include occurrence time, number of injections, clinical manifestations, and management measures., After each treatment. Up to 36 months
Secondary Outcome Measures: Visual Analog Scale (VAS), Pain perception of allergy symptoms during treatment will be evaluated using a scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates maximum pain., Pre-intervention screening period; 3 months, 6 months, 12 months, 24 months, 36 months after the first intervention. Up to 36 months|Absolute Value and Percentage of Blood Leukocytes, Changes in blood eosinophil absolute value (EOS), eosinophil percentage (EOS%), basophil absolute value (BAS), and basophil percentage (BAS%) will be evaluated., Pre-intervention screening period; 3 months, 6 months, 12 months, 24 months, 36 months after the first intervention. Up to 36 months|Concentration of Key Serum Cytokines, Changes in key serum cytokines, including TNF-α, IFN-γ, IL-2, IL-4, IL-6, IL-10, and IL-17, will be evaluated at the same intervals as CSMS., Pre-intervention screening period; 3 months, 6 months, 12 months, 24 months, 36 months after the first intervention. Up to 36 months|Concentration of Serum Immune Globulins, Changes in serum total IgE (tIgE), IgA, IgG, and specific IgE (sIgE) will be evaluated at the same intervals as CSMS., Pre-intervention screening period; 3 months, 6 months, 12 months, 24 months, 36 months after the first intervention. Up to 36 months|Proportion of Blood T Cell Differentiation, Changes in the proportion of blood T cell differentiation (Th, Tfh, Tfr, Treg, Tfc, Tex, etc.) will be evaluated., Pre-intervention screening period; 3 months, 6 months, 12 months, 24 months, 36 months after the first intervention. Up to 36 months|RQLQ, Administration of questionnaires, the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)., Pre-intervention screening period; 3 months, 6 months, 12 months, 24 months, 36 months after the first intervention. Up to 36 months|Concentration of FeNO, Change of FeNO, Pre-intervention screening period; 3 months, 6 months, 12 months, 24 months, 36 months after the first intervention. Up to 36 months