NCT06523478 Intratonsillar Immunotherapy for Allergic Rhinitis
| NCT ID | NCT06523478 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xu Yu |
| Condition | Allergic Rhinitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-04-29 |
| Primary Completion | 2028-04-29 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2024-04-29 with a primary completion date of 2028-04-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a prospective, open-label, positive parallel controlled, blinded endpoint clinical study designed to compare the safety and efficacy of "Intratonsillar Immunotherapy of Standardized Dust Mite Allergen Extracts (Novo Helisen-Depot, Allergopharma, Merck, Germany)" with Subcutaneous Immunotherapy in patients with "Dust Mite Allergic Rhinitis." Participants will be evaluated for safety and efficacy throughout the entire three-year period.
Eligibility Criteria
Inclusion Criteria: * Voluntarily sign informed consent. * Commitment to follow the research procedures and cooperate with the implementation of the entire research process. * Diagnosis in accordance with ARIA guidelines, based on: ① Symptoms: Two or more symptoms such as paroxysmal sneezing, watery nose, nasal itching, and nasal congestion, with symptoms lasting or accumulating for more than 1 hour per day. May be accompanied by eye symptoms such as tearing, eye itching, and eye redness. ② Signs: Common nasal mucosa pale, edema, nasal watery secretions. * Allergen test: Positive for skin prick test (SPT) and/or serum-specific IgE for at least one allergen, or positive for nasal provocation test. * Have a history of allergic rhinitis caused by atopic allergens and one of the following: ① No significant relief after drug treatment. ② Do not want to continue taking medication for a long time. ③ Long-term drug treatment can produce adverse side effects. * Allergens cannot be effectively avoided in daily life. * Women of childbearing age must ensure that they do not become pregnant during the treatment cycle. * Must be between 5 and 65 years old. Exclusion Criteria: * Allergic to the excipient (aluminum hydroxide) of Allergopharma or the rescue medication epinephrine. * Respiratory disease other than stable asthma. * Pulmonary insufficiency (NYHA grade II and above or FEV1 \< 80%) or irreversible changes in the responding organs such as emphysema and bronchiectasis. * Severe acute or chronic diseases (including malignant diseases), inflammation, and fever. * Multiple sclerosis. * Immune system diseases (autoimmune diseases, immune diseases caused by antigen and antibody complexes, immune deficiencies, etc.). * Active tuberculosis. * Severe mental disorder. * Obvious cardiac insufficiency. * A history of severe recurrent acute sinusitis (defined as two episodes per year within the past 2 years, each requiring antibiotic treatment). * A history of chronic sinusitis, including at least two of the following symptoms (at least one of which should be nasal congestion or runny nose): ① Nasal congestion, runny nose, facial pressure, or pain. ② Having a diminished or lost sense of smell. ③ Endoscopic or CT examination showed signs of sinusitis. * Severe liver and renal impairment, including but not limited to abnormal liver function (such as ALT, AST elevation more than 2 times the normal range), abnormal kidney function (such as creatinine clearance less than 60 mL/min), etc. * Smokers averaging more than 5 cigarettes per day in the 3 months prior to the trial or unable to give up smoking during the entire hospital stay. * Regular drinkers in the 3 months prior to the trial, i.e., more than 2 units of alcohol per day on average (1 unit = 360ml beer or 45ml spirits with 40% alcohol or 150ml wine). * Received immunotherapy within the last 3 years (subcutaneous injection or sublingual allergen-specific immunotherapy, etc.). * Patients who used experimental drugs or participated in other clinical studies within 30 days prior to treatment. * Patients treated with IgE monoclonal antibodies within the last 4 months. * Patients who are taking beta blockers. * Patients who do not have sufficient knowledge about the trial. * Not between the ages of 5 and 65. * Patients who are pregnant or nursing during the study period, or who plan to become pregnant. * Patients who are unable to have tonsil injections due to chronic tonsillitis, small tonsils, prior tonsillectomy, etc.
Contact & Investigator
Yu Xu
STUDY CHAIR
Renmin Hospital of Wuhan University
Frequently Asked Questions
Who can join the NCT06523478 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 65 Years, studying Allergic Rhinitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06523478 currently recruiting?
Yes, NCT06523478 is actively recruiting participants. Contact the research team at xuy@whu.edu.cn for enrollment information.
Where is the NCT06523478 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT06523478 clinical trial?
NCT06523478 is sponsored by Xu Yu. The principal investigator is Yu Xu at Renmin Hospital of Wuhan University. The trial plans to enroll 120 participants.