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

Inclusion criteria

• 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

Exclusion criteria

• 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