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New treatment option for Allergic Rhinitis
Official title Intratonsillar Immunotherapy for Allergic Rhinitis
ClinicalTrials.gov ID: NCT06523478
What this study is testing
- What it's testing
- 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.
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 65
You may be able to join 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...
- 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...
You likely can't join 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...
- 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.).
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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.
What rules you out
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.