Evaluation of the Efficacy and Safety of an Intensified Strategy of Intratonsillar Immunotherapy (ITIT) for Allergic Rhinitis: A Multicenter, Randomized, Double-blind, Controlled Trial

Обзор

This is a multicenter, randomized, double-blind, controlled trial to evaluate the efficacy and safety of an enhanced strategy of allergen-specific immunotherapy (ITIT) in the treatment of allergic rhinitis. By recording the changes in CSMS from baseline to post-treatment in the subjects and the incidence of adverse reactions after treatment, the differences in efficacy and safety between the patients who received the basic three doses and those who received booster injections were compared. Furthermore, the impact of different booster strategies on long-term efficacy was compared to optimize the injection strategy. At the same time, the influence of different administration procedures on the immune response was evaluated.

Вмешательства

• Процедура Basic Intratonsillar Immunotherapy (ITIT)
  During injection, the operator needs to gently shake the injection bottle about 20 times, the drug must be mixed to ensure the consistency of allergen concentration, and carefully check the patient's name and concentration on the bottle. Allergy extracts should not be injected intravenously, so the syringe will be aspirated to avoid inadvertent intravascular injection. Before each injection, after inserting the needle into the selected tonsil, before injecting the dose, the investigator will sli
• Процедура Strengthen Intratonsillar Immunotherapy (ITIT)
  During injection, the operator needs to gently shake the injection bottle about 20 times, the drug must be mixed to ensure the consistency of allergen concentration, and carefully check the patient's name and concentration on the bottle. Allergy extracts should not be injected intravenously, so the syringe will be aspirated to avoid inadvertent intravascular injection. Before each injection, after inserting the needle into the selected tonsil, before injecting the dose, the investigator will sli

Первичные конечные точки

• CSMS [Срок оценки: Before treatment (baseline) and at 1, 2, 3, 6, 12, 24, and 36 months after treatment.]
• adverse event [Срок оценки: 30 minutes after each treatment (at the 0th, 1st, 2nd, 6th, 12th, 18th and 24th months).]

Вторичные конечные точки (7)

• Visual Analog Scale (VAS) [Срок оценки: Before treatment (baseline) and at 1, 2, 3, 6, 12, 24, and 36 months after treatment.]
• Absolute Value and Percentage of Blood Leukocytes [Срок оценки: Before treatment (baseline) and at 6, 12, 24, and 36 months after treatment.]
• Concentration of Key Serum Cytokines [Срок оценки: Before treatment (baseline) and at 6, 12, 24, and 36 months after treatment.]
• Concentration of Serum Immune Globulins [Срок оценки: Before treatment (baseline) and at 6, 12, 24, and 36 months after treatment.]
• Proportion of T Cell Differentiation [Срок оценки: Before treatment (baseline) and at 6, 12, 24, and 36 months after treatment.]
• ARCT [Срок оценки: At 1, 2, 3, 6, 12, 24, and 36 months after treatment.]
• miniRQLQ [Срок оценки: Before treatment (baseline) and at 1, 2, 3, 6, 12, 24, and 36 months after treatment.]

Критерии участия

Критерии включения

• Voluntary signing of the informed consent form
• Commitment to abide by the research procedures and cooperate throughout the implementation of the research
• Diagnosis conforms to the ARIA guidelines. The basis for the diagnosis is as follows: a. Symptoms: Paroxysmal sneezing, clear nasal discharge, nasal itching, and nasal congestion occur for 2 or more times, with symptoms persisting or accumulating for more than 1 hour each day, accompanied by tearing, eye itching, and eye redness and other ocular symptoms; b. Signs: Commonly, the nasal mucosa is pale and edematous, and nasal watery secretions are present; c. Allergen testing: Positive results for dust mite allergens SPT and/or serum-specific IgE, or positive nasal challenge test, requiring Der p and Der f to be positive (SPT results of ++ or higher, serum sIgE ≥ 2 grades), and other allergens in the allergen test to be negative
• History of allergic rhinitis caused by atopic dust mite allergens
• Infertile women must ensure they do not become pregnant during the treatment period
• Age must be between 5 and 60 years old

Критерии исключения

• Allergic to the excipients of Arrogel (aluminum hydroxide) or the rescue medication epinephrine
• Suffering from respiratory system diseases other than stable asthma
• Pulmonary dysfunction (NYHA grade II or above, or FeV1 < 70%) or having irreversible pathological changes in the reactive organs such as emphysema or bronchiectasis
• Severe acute or chronic diseases (including malignant diseases), inflammation and fever
• Multiple sclerosis
• Immune system diseases (autoimmune diseases, immune diseases caused by antigen-antibody complexes, immune deficiencies, etc.)
• Active pulmonary tuberculosis
• Severe mental disorders
• Obvious cardiac dysfunction
• Patients who have received immunotherapy within the last 1 years (subcutaneous injection or sublingual administration of allergen-specific immunotherapy, etc.)
• Patients who used experimental drugs or participated in other clinical studies within 30 days before treatment
• Patients who received IgE monoclonal antibody (mAb) treatment in the past 4 months
• Patients taking beta-blockers
• Patients who have insufficient understanding of the trial
• Patients whose age is not between 5 years old and 65 years old
• Patients who are pregnant or breastfeeding during the study period, or have plans to get pregnant
• Patients who cannot undergo tonsil injection due to acute or chronic tonsillitis, small tonsils, previous tonsillectomy, overly sensitive pharyngeal reflex and inability to cooperate with treatment
• Patients with aphthous stomatitis

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Renmin Hospital of Wuhan University — Ухань

Публикации

• Gu T, Zhang W, Tan L, Xiang R, Liu P, Huang J, Deng Q, Deng Y, Tao Z, Chen S, Xu Y. Intratonsillar Immunotherapy: A Convenient and Effective Alternative to Subcutaneous Immunotherapy for Allergic Rhinitis. Research (Wash D C). 2025 Jan 16;8:0573. doi: 10.34133/research.0573. eCollection 2025. PMID 39822282

Идентификаторы

NCT: NCT07269509 · WDRY2025-K209(X01)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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