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NCT07269509

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

Sponsor: Renmin Hospital of Wuhan University

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

5 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

276

Start Date

2025-12-30

Completion Date

2029-02-28

Last Updated

2025-12-08

Healthy Volunteers

Conditions

Allergic Rhinitis

Interventions

PROCEDURE

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 slightly pull the plunger of the syringe. If blood returns from the syringe, the syringe, and its contents will be discarded. The other tonsil will be selected and a new syringe will be prepared. 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.

PROCEDURE

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 slightly pull the plunger of the syringe. If blood returns from the syringe, the syringe, and its contents will be discarded. The other tonsil will be selected and a new syringe will be prepared. Inject mite allergen solution into the tonsil at the 0th, 1st, 2nd, 6th, 12th, 18th and 24th months.

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

Locations (1)

Renmin Hospital of Wuhan University

Wuhan, Hubei, China