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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 65
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
Renmin Hospital of Wuhan University
RECRUITING
Wuhan
Contact Information
Primary
Yu Xu, Doctor
xuy@whu.edu.cn
+8615927088198
Backup
Tian Gu, Master
gutian@whu.edu.cn
+8615515283168
Time Frame
Start Date: 2024-04-29
Estimated Completion Date: 2028-04-29
Participants
Target number of participants: 120
Treatments
Experimental: Intratonsillar Immunotherapy (ITIT) group
The intervention of ITIT will be a series of 3 injections of a commercially-available standardized dust mite allergen extracts (Novo Helisen-Depot, Allergopharma, Merck, Germany) given every four weeks into tonsil through guidance using a 1-mL hypodermic syringe with a 25-gauge or smaller needle. The specific doses are 5 TU (0.1 ml, the first injection), 50 TU (0.1 ml, the second injection), and 50 TU (0.1 ml, the third injection).~Before each injection, patients will take one tablet of antihistamine.
Active_comparator: Subcutaneous Immunotherapy (SCIT) group
The same drugs will be used in active comparator. SCIT consists of two stages: the accumulation stage and the maintenance stage. During the initial 14 weeks, patients will receive sequential subcutaneous injections as follows: (1) 1st vial: 0.1 mL, 0.2 mL, 0.4 mL, and 0.8 mL; (2) 2nd vial: 0.1 mL, 0.2 mL, 0.4 mL, and 0.8 mL; (3) 3rd vial: 0.1 mL, 0.2 mL, 0.4 mL, 0.6 mL, 0.8 mL, and 1.0 mL of allergen, achieving a maintenance dose of 5000 TU. Subsequently, maintenance therapy involves subcutaneous injections of 5000 TU (1.0 mL, 3rd vial) every 4-6 weeks. The intervention process before and after each injection is similar to that of the ITIT group.
Related Therapeutic Areas
Sponsors
Leads: Xu Yu

This content was sourced from clinicaltrials.gov