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

NCT07269509 | Not Yet Recruiting

• 1 other identifier: WDRY2025-K209(X01)
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

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

Keywords

Allergic rhinitis; Intratonsillar; Allergen immunotherapy; Standardized dust mite allergen extracts

Outcome Measures

Primary Outcomes (2)

• CSMS

  combined symptom and medication score

  Before treatment (baseline) and at 1, 2, 3, 6, 12, 24, and 36 months after treatment.

• adverse event

  Observe adverse events and classify them according to the World Allergy Organization (WAO) subcutaneous immunotherapy reaction classification system.

  30 minutes after each treatment (at the 0th, 1st, 2nd, 6th, 12th, 18th and 24th months).

Secondary Outcomes (7)

• 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.

Study Arms (2)

experimental group

EXPERIMENTAL

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

Procedure: Strengthen Intratonsillar Immunotherapy (ITIT)

control group

PLACEBO COMPARATOR

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: Basic Intratonsillar Immunotherapy (ITIT)

Interventions

Basic Intratonsillar Immunotherapy (ITIT) 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.

control group

Strengthen Intratonsillar Immunotherapy (ITIT) 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.

experimental group

Eligibility Criteria

• Age: 5 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Renmin Hospital of Wuhan University: lead

Study Sites (1)

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

Location

Related Publications (1)

• 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.

  PMID: 39822282 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Yu Xu, Doctor

CONTACT

+8615927088198; xuy@whu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 8, 2025
• Study Start: December 30, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): February 28, 2029
• Last Updated: December 8, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Two years after the completion of the trial
• Access Criteria: Upon approval of the request, access to the de-identified individual patient-level data will be provided. Before accessing the requested information, a data sharing agreement (a non-negotiable contract for data visitors) must be signed.

Locations

CN (1)