Intratonsillar Immunotherapy for Allergic Rhinitis

Recruiting now · Not applicable

Conditions studied: Allergic Rhinitis

In brief

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.

Key facts

Study ID

NCT06523478

Run by

Xu Yu

People needed

120

Starts

2024-04-29

Expected to finish

2028-04-29

Last updated by the study team

2024-07-26

Who can join

Age: 5 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

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

Full record on ClinicalTrials.gov

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