Status:
RECRUITING
Intratonsillar Immunotherapy for Allergic Rhinitis
Lead Sponsor:
Xu Yu
Conditions:
Allergic Rhinitis
Eligibility:
All Genders
5-65 years
Phase:
NA
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 ...
Detailed Description
Background: Allergic Rhinitis (AR) presents both nasal and non-nasal symptoms. The global incidence of AR is rising, causing a significant burden. Seasonal allergic rhinitis (SAR) and perennial aller...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 29 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06523478
Start Date
April 29 2024
End Date
April 29 2028
Last Update
July 26 2024
Active Locations (1)
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1
Renmin Hospital of Wuhan University
Wuhan, Hubei, China, 430060