Evaluation of the Efficacy and Safety of an Intensified Strategy of Intratonsillar Immunotherapy (ITIT) for Allergic Rhinitis: A Multicenter, Randomized, Double-blind, Controlled Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-65
SponsorRenmin Hospital of Wuhan University

About this trial

This is a multicenter, randomized, double-blind, controlled trial to evaluate the efficacy and safety of an enhanced strategy of allergen-specific immunotherapy (ITIT) in the treatment of allergic rhinitis. By recording the changes in CSMS from baseline to post-treatment in the subjects and the incidence of adverse reactions after treatment, the differences in efficacy and safety between the patients who received the basic three doses and those who received booster injections were compared. Furthermore, the impact of different booster strategies on long-term efficacy was compared to optimize the injection strategy. At the same time, the influence of different administration procedures on the immune response was evaluated.

Eligibility criteria

Qualifiers

Voluntary signing of the informed consent form

Commitment to abide by the research procedures and cooperate throughout the implementation of the research

Diagnosis conforms to the ARIA guidelines. The basis for the diagnosis is as follows: a. Symptoms: Paroxysmal sneezing, clear nasal discharge, nasal itching, and nasal congestion occur for 2 or more times, with symptoms persisting or accumulating for more than 1 hour each day, accompanied by tearing, eye itching, and eye redness and other ocular symptoms; b. Signs: Commonly, the nasal mucosa is pale and edematous, and nasal watery secretions are present; c. Allergen testing: Positive results for dust mite allergens SPT and/or serum-specific IgE, or positive nasal challenge test, requiring Der p and Der f to be positive (SPT results of ++ or higher, serum sIgE ≥ 2 grades), and other allergens in the allergen test to be negative

History of allergic rhinitis caused by atopic dust mite allergens

Disqualifiers

Allergic to the excipients of Arrogel (aluminum hydroxide) or the rescue medication epinephrine

Suffering from respiratory system diseases other than stable asthma

Pulmonary dysfunction (NYHA grade II or above, or FeV1 < 70%) or having irreversible pathological changes in the reactive organs such as emphysema or bronchiectasis

Severe acute or chronic diseases (including malignant diseases), inflammation and fever

Trial design

Treatments tested in this trial

  • Basic Intratonsillar Immunotherapy (ITIT)
  • Strengthen Intratonsillar Immunotherapy (ITIT)

Treatment groups

276 Participants
are divided into 2 treatment groups