RecruitingNot ApplicableNCT06523478

Intratonsillar Immunotherapy for Allergic Rhinitis

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

Sponsor

Xu Yu

Enrollment

120 participants

Start Date

Apr 29, 2024

Study Type

INTERVENTIONAL

Conditions

Allergic Rhinitis

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

Min Age: 5 YearsMax Age: 65 Years

Inclusion Criteria13

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 Criteria25

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.

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Interventions

PROCEDUREIntratonsillar 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.

PROCEDURESubcutaneous immunotherapy (SCIT)

Injection requires shaking bottle 20x to mix drug for consistency. Verify patient name \& concentration. Use 1 ml skin test syringe for deep subcutaneous injection at 45° angle, 1 cm into outer upper arm. Lift skin folds for deeper injection, avoid subcutaneous, muscular or intravascular. Inject slowly, 1 min for 1 ml. Avoid shallow injections which may cause local side effects. Alternate between left \& right arm for 5 min after injection for compression.