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Intratonsillar Immunotherapy for Allergic Rhinitis

RecruitingNAAges 5 Years - 65 YearsAllXu Yu
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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: โ‘  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. โ‘ก 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: โ‘  No significant relief after drug treatment. โ‘ก Do not want to continue taking medication for a long time. โ‘ข 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): โ‘  Nasal congestion, runny nose, facial pressure, or pain. โ‘ก Having a diminished or lost sense of smell. โ‘ข 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.
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What it tests

  • Intratonsillar immunotherapy (ITIT)
  • Subcutaneous immunotherapy (SCIT)
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Where

1 site
Renmin Hospital of Wuhan University
Wuhan, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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