Intratonsillar immunotherapy for allergic rhinitis treatment

A Study on the Efficacy and Safety of Intratonsillar Immunotherapy for Allergic Rhinitis

This study is testing a new way to treat dust mite allergies using a special therapy applied to the tonsils to see if it works better than the usual allergy shots.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 5 Years to 65 Years
• Sex: All
• Sponsor: Renmin Hospital of Wuhan University (Academic / other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT06523478 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of intratonsillar immunotherapy using standardized dust mite allergen extracts compared to subcutaneous immunotherapy in patients suffering from dust mite allergic rhinitis. The study is designed as a prospective, open-label, positive parallel controlled trial with blinded endpoints, and participants will be monitored over a three-year period. The research aims to explore the immune response mechanisms involved in allergen immunotherapy and assess the potential benefits of this novel approach.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals diagnosed with allergic rhinitis who have not found significant relief from conventional drug treatments.

Not a fit: Patients who have not been diagnosed with allergic rhinitis or those who are currently receiving effective treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective and safer option for patients with allergic rhinitis, potentially reducing their symptoms and reliance on medications.

How similar studies have performed: Previous studies have shown success with similar immunotherapy approaches, particularly in animal models, but this specific intratonsillar method is relatively novel.

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.

Where this trial is running

Wuhan, Hubei

• Renmin Hospital of Wuhan University — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Yu Xu, Doctor

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