Intratonsillar Immunotherapy for Allergic Rhinitis (NCT06523478) | Clinical Trial Compass
RecruitingNot Applicable
Intratonsillar Immunotherapy for Allergic Rhinitis
China120 participantsStarted 2024-04-29
Plain-language 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.
Who can participate
Age range
5 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
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 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 bronchi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Combined Symptom and Medication Score (CSMS)
Timeframe: Pre-intervention screening period; 3 months, 6 months, 12 months, 24 months, 36 months after the first intervention. Up to 36 months
2
Number of Participants with Local or Systemic Adverse Reactions