Evaluation of the Efficacy and Safety of an Intensified Strategy of Intratonsillar Immunotherapy (ITIT) for Allergic Rhinitis: A Multicenter, Randomized, Double-blind, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 276
- 试验地点
- 2
- 主要终点
- CSMS
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 5 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
CSMS
时间窗: Before treatment (baseline) and at 1, 2, 3, 6, 12, 24, and 36 months after treatment.
combined symptom and medication score
adverse event
时间窗: 30 minutes after each treatment (at the 0th, 1st, 2nd, 6th, 12th, 18th and 24th months).
Observe adverse events and classify them according to the World Allergy Organization (WAO) subcutaneous immunotherapy reaction classification system.
CSMS
时间窗: Before treatment (baseline) and at 1, 2, 3, 6, 12, 24, and 36 months after treatment.
combined symptom and medication score
adverse event
时间窗: 30 minutes after each treatment (at the 0th, 1st, 2nd, 6th, 12th, 18th and 24th months).
Observe adverse events and classify them according to the World Allergy Organization (WAO) subcutaneous immunotherapy reaction classification system.
次要结局
- Proportion of T Cell Differentiation(Before treatment (baseline) and at 6, 12, 24, and 36 months after treatment.)
- Concentration of Key Serum Cytokines(Before treatment (baseline) and at 6, 12, 24, and 36 months after treatment.)
- Concentration of Serum Immune Globulins(Before treatment (baseline) and at 6, 12, 24, and 36 months after treatment.)
- ARCT(At 1, 2, 3, 6, 12, 24, and 36 months after treatment.)
- miniRQLQ(Before treatment (baseline) and at 1, 2, 3, 6, 12, 24, and 36 months after treatment.)
- Visual Analog Scale (VAS)(Before treatment (baseline) and at 1, 2, 3, 6, 12, 24, and 36 months after treatment.)
- Absolute Value and Percentage of Blood Leukocytes(Before treatment (baseline) and at 6, 12, 24, and 36 months after treatment.)
- Visual Analog Scale (VAS)(Before treatment (baseline) and at 1, 2, 3, 6, 12, 24, and 36 months after treatment.)
- Absolute Value and Percentage of Blood Leukocytes(Before treatment (baseline) and at 6, 12, 24, and 36 months after treatment.)
- Concentration of Key Serum Cytokines(Before treatment (baseline) and at 6, 12, 24, and 36 months after treatment.)
- Concentration of Serum Immune Globulins(Before treatment (baseline) and at 6, 12, 24, and 36 months after treatment.)
- Proportion of T Cell Differentiation(Before treatment (baseline) and at 6, 12, 24, and 36 months after treatment.)
- ARCT(At 1, 2, 3, 6, 12, 24, and 36 months after treatment.)
- miniRQLQ(Before treatment (baseline) and at 1, 2, 3, 6, 12, 24, and 36 months after treatment.)