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

Wuhan University

Status: Not yet enrolling

Conditions: Allergic Rhinitis

Treatments: Procedure: Basic Intratonsillar Immunotherapy (ITIT); Procedure: Strengthen Intratonsillar Immunotherapy (ITIT)

Study type: Interventional

Funder types: Other

Identifiers

NCT07269509

WDRY2025-K209(X01)

Details and patient eligibility

About

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.

Enrollment: 276 estimated patients

Sex: All

Ages: 5 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Voluntary signing of the informed consent form
2. Commitment to abide by the research procedures and cooperate throughout the implementation of the research
3. 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
4. History of allergic rhinitis caused by atopic dust mite allergens
5. Infertile women must ensure they do not become pregnant during the treatment period
6. Age must be between 5 and 60 years old

Exclusion criteria

1. Allergic to the excipients of Arrogel (aluminum hydroxide) or the rescue medication epinephrine
2. Suffering from respiratory system diseases other than stable asthma
3. Pulmonary dysfunction (NYHA grade II or above, or FeV1 < 70%) or having irreversible pathological changes in the reactive organs such as emphysema or bronchiectasis
4. Severe acute or chronic diseases (including malignant diseases), inflammation and fever
5. Multiple sclerosis
6. Immune system diseases (autoimmune diseases, immune diseases caused by antigen-antibody complexes, immune deficiencies, etc.)
7. Active pulmonary tuberculosis
8. Severe mental disorders
9. Obvious cardiac dysfunction
10. Patients who have received immunotherapy within the last 1 years (subcutaneous injection or sublingual administration of allergen-specific immunotherapy, etc.)
11. Patients who used experimental drugs or participated in other clinical studies within 30 days before treatment
12. Patients who received IgE monoclonal antibody (mAb) treatment in the past 4 months
13. Patients taking beta-blockers
14. Patients who have insufficient understanding of the trial
15. Patients whose age is not between 5 years old and 65 years old
16. Patients who are pregnant or breastfeeding during the study period, or have plans to get pregnant
17. 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
18. Patients with aphthous stomatitis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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276 participants in 2 patient groups, including a placebo group

experimental group

Experimental group

Description:

Inject mite allergen solution into the tonsil at the 0th, 1st, 2nd, 6th, 12th, 18th and 24th months.

Treatment:

Procedure: Strengthen Intratonsillar Immunotherapy (ITIT)

control group

Placebo Comparator group

Description:

Inject the mite allergen solution into the tonsil at months 0, 1, 2, 12, and 24, and administer the placebo at months 6 and 18.

Treatment:

Procedure: Basic Intratonsillar Immunotherapy (ITIT)