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

NCT ID: NCT07269509

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 276 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-30
• Study Completion Date: 2029-02-28

Brief 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.

Conditions

Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

experimental group

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

Group Type: EXPERIMENTAL

Strengthen Intratonsillar Immunotherapy (ITIT)

Intervention Type: PROCEDURE

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.

control group

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.

Group Type: PLACEBO_COMPARATOR

Basic Intratonsillar Immunotherapy (ITIT)

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Renmin Hospital of Wuhan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Countries

China

Central Contacts

Yu Xu, Doctor

Role: CONTACT

xuy@whu.edu.cn

+8615927088198

Facility Contacts

Yu Xu, Doctor

Role: primary

xuy@whu.edu.cn

+8615927088198

References

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.

Reference Type: BACKGROUND

PMID: 39822282 (View on PubMed)

Related Links

https://www.medicalresearch.org.cn/

Related Info

Other Identifiers

WDRY2025-K209(X01)

Identifier Type: -

Identifier Source: org_study_id