Actively Recruiting
Intratonsillar Immunotherapy for Allergic Rhinitis
Led by Xu Yu · Updated on 2024-07-26
120
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intratonsillar Immunotherapy for Allergic Rhinitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign informed consent.
- Agreement to follow the research procedures and cooperate throughout the study.
- Diagnosis of allergic rhinitis according to ARIA guidelines with two or more symptoms lasting over 1 hour daily, possibly including eye symptoms.
- Positive allergen test by skin prick, serum-specific IgE, or nasal provocation test.
- History of allergic rhinitis caused by atopic allergens with no significant relief from drugs, unwillingness to continue long-term medication, or adverse side effects from medication.
- Allergens cannot be effectively avoided in daily life.
- Women of childbearing age must ensure no pregnancy during treatment.
- Age between 5 and 65 years old.
You will not qualify if you...
- Allergy to aluminum hydroxide or epinephrine.
- Respiratory diseases other than stable asthma.
- Pulmonary insufficiency or irreversible organ changes such as emphysema or bronchiectasis.
- Severe acute or chronic diseases including malignancies, inflammation, or fever.
- Multiple sclerosis.
- Immune system diseases including autoimmune and immune deficiency disorders.
- Active tuberculosis.
- Severe mental disorders.
- Obvious cardiac insufficiency.
- Severe recurrent acute sinusitis (two episodes per year in past 2 years requiring antibiotics).
- Chronic sinusitis with symptoms like nasal congestion, runny nose, facial pain, loss of smell, or imaging signs.
- Severe liver or kidney impairment.
- Smoking more than 5 cigarettes daily in past 3 months or inability to quit during hospital stay.
- Regular alcohol use exceeding 2 units daily in past 3 months.
- Immunotherapy within last 3 years.
- Use of experimental drugs or participation in other studies within 30 days before treatment.
- Treatment with IgE monoclonal antibodies within last 4 months.
- Use of beta blockers.
- Insufficient knowledge about the trial.
- Not aged between 5 and 65.
- Pregnant, nursing, or planning pregnancy during study.
- Unable to undergo tonsil injections due to tonsil conditions or prior tonsillectomy.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Renmin Hospital of Wuhan University
Wuhan, Hubei, China, 430060
Actively Recruiting
Research Team
Y
Yu Xu, Doctor
CONTACT
T
Tian Gu, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here