Allergic RhinitisNCT07269509
Evaluation of the Efficacy and Safety of an Intensified Strategy of Intratonsillar Immunotherapy (ITIT) for Allergic Rhinitis: A Multicenter, Randomized, Double-blind, Controlled Trial
A study testing Basic Intratonsillar Immunotherapy (ITIT) and Strengthen Intratonsillar Immunotherapy (ITIT) in people with Allergic Rhinitis, run by Renmin Hospital of Wuhan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 65 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Basic Intratonsillar Immunotherapy (ITIT) and Strengthen Intratonsillar Immunotherapy (ITIT)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 276 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2025to 28 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
Yu Xu, Doctor, +8615927088198, xuy@whu.edu.cn
About this study
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
- Being tested
- Basic Intratonsillar Immunotherapy (ITIT), Strengthen Intratonsillar Immunotherapy (ITIT)
- Keywords
- Allergic rhinitis, Intratonsillar, Allergen immunotherapy, Standardized dust mite allergen extracts
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basic Intratonsillar Immunotherapy (ITIT)Procedure or surgery
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.
Strengthen Intratonsillar Immunotherapy (ITIT)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Inject mite allergen solution into the tonsil at the 0th, 1st, 2nd, 6th, 12th, 18th and 24th months. Receives: 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. Receives: Procedure: Basic Intratonsillar Immunotherapy (ITIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
CSMS
combined symptom and medication score
Measured: 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.
Measured: 30 minutes after each treatment (at the 0th, 1st, 2nd, 6th, 12th, 18th and 24th months).
Secondary outcomes (7)
Visual Analog Scale (VAS)
Pain perception of allergy symptoms during treatment will be evaluated using a scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates maximum pain.
Measured: Before treatment (baseline) and at 1, 2, 3, 6, 12, 24, and 36 months after treatment.
Absolute Value and Percentage of Blood Leukocytes
Measured: Before treatment (baseline) and at 6, 12, 24, and 36 months after treatment.
Concentration of Key Serum Cytokines
Measured: Before treatment (baseline) and at 6, 12, 24, and 36 months after treatment.
Concentration of Serum Immune Globulins
Measured: Before treatment (baseline) and at 6, 12, 24, and 36 months after treatment.
Proportion of T Cell Differentiation
Measured: Before treatment (baseline) and at 6, 12, 24, and 36 months after treatment.
ARCT
The Allergic Rhinitis Control Test Questionnaire
Measured: At 1, 2, 3, 6, 12, 24, and 36 months after treatment.
miniRQLQ
mini Rhinoconjunctivitis Quality of Life Questionnaire
Measured: Before treatment (baseline) and at 1, 2, 3, 6, 12, 24, and 36 months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start30 Dec 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renmin Hospital of Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07269509
- Sponsor's protocol ID
- WDRY2025-K209(X01)
- Status last verified
- Nov 2025
- First submitted
- 25 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Two years after the completion of the trial, data will be published on the EDC (http://edc.eplat.com.cn/).
Publications
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.
PubMed 39822282
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of an Intensified Strategy of Intratonsillar Immunotherapy (ITIT) for Allergic Rhinitis: A Multicenter, Randomized, Double-blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT07269509
- Acronym / sponsor ID
- WDRY2025-K209(X01)
- Conditions
- Allergic Rhinitis
- Keywords
- Allergic rhinitis, Intratonsillar, Allergen immunotherapy, Standardized dust mite allergen extracts
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Study start
- 30 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Procedure: Strengthen Intratonsillar Immunotherapy (ITIT)Inject mite allergen solution into the tonsil at the 0th, 1st, 2nd, 6th, 12th, 18th and 24th months. |
| control group | Placebo comparator | Procedure: Basic Intratonsillar Immunotherapy (ITIT)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. |
Who may qualify
- Ages
- 5 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | control group |
| 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. | Procedure or surgery | experimental group |
Primary outcome
CSMS
Time frame: Before treatment (baseline) and at 1, 2, 3, 6, 12, 24, and 36 months after treatment.
combined symptom and medication score
adverse event
Time frame: 30 minutes after each treatment (at the 0th, 1st, 2nd, 6th, 12th, 18th and 24th months).
Observe adverse events and classify them according to the World Allergy Organization (WAO) subcutaneous immunotherapy reaction classification system.
7 secondary outcomes
Visual Analog Scale (VAS)
Time frame: Before treatment (baseline) and at 1, 2, 3, 6, 12, 24, and 36 months after treatment.
Absolute Value and Percentage of Blood Leukocytes
Time frame: Before treatment (baseline) and at 6, 12, 24, and 36 months after treatment.
Concentration of Key Serum Cytokines
Time frame: Before treatment (baseline) and at 6, 12, 24, and 36 months after treatment.
Concentration of Serum Immune Globulins
Time frame: Before treatment (baseline) and at 6, 12, 24, and 36 months after treatment.
Proportion of T Cell Differentiation
Time frame: Before treatment (baseline) and at 6, 12, 24, and 36 months after treatment.
ARCT
Time frame: At 1, 2, 3, 6, 12, 24, and 36 months after treatment.
miniRQLQ
Time frame: Before treatment (baseline) and at 1, 2, 3, 6, 12, 24, and 36 months after treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Background: PubMed 39822282Gu 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Two years after the completion of the trial, data will be published on the EDC (http://edc.eplat.com.cn/).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Basic Intratonsillar Immunotherapy (ITIT) and Strengthen Intratonsillar Immunotherapy (ITIT) in people with Allergic Rhinitis, run by Renmin Hospital of Wuhan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu Xu, Doctor (+8615927088198, xuy@whu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CSMS (time frame: Before treatment (baseline) and at 1, 2, 3, 6, 12, 24, and 36 months after treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07269509, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.