Allergic Rhinitis
Conditions
Keywords
Allergic rhinitis, Intratonsillar, Allergen immunotherapy, Standardized dust mite allergen extracts
Brief summary
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.
Interventions
PROCEDUREBasic Intratonsillar Immunotherapy (ITIT)
During injection, the operator needs to gently shake the injection bottle about 20 times, the drug must be mixed to ensure the consistency of allergen concentration, and carefully check the patient's name and concentration on the bottle. Allergy extracts should not be injected intravenously, so the syringe will be aspirated to avoid inadvertent intravascular injection. Before each injection, after inserting the needle into the selected tonsil, before injecting the dose, the investigator will slightly pull the plunger of the syringe. If blood returns from the syringe, the syringe, and its contents will be discarded. The other tonsil will be selected and a new syringe will be prepared. Inject the mite allergen solution into the tonsil at months 0, 1, 2, 12, and 24, and administer the placebo at months 6 and 18.
PROCEDUREStrengthen Intratonsillar Immunotherapy (ITIT)
During injection, the operator needs to gently shake the injection bottle about 20 times, the drug must be mixed to ensure the consistency of allergen concentration, and carefully check the patient's name and concentration on the bottle. Allergy extracts should not be injected intravenously, so the syringe will be aspirated to avoid inadvertent intravascular injection. Before each injection, after inserting the needle into the selected tonsil, before injecting the dose, the investigator will slightly pull the plunger of the syringe. If blood returns from the syringe, the syringe, and its contents will be discarded. The other tonsil will be selected and a new syringe will be prepared. Inject mite allergen solution into the tonsil at the 0th, 1st, 2nd, 6th, 12th, 18th and 24th months.
Sponsors
Renmin Hospital of Wuhan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
5 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Voluntary signing of the informed consent form 2. Commitment to abide by the research procedures and cooperate throughout the implementation of the research 3. 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 4. History of allergic rhinitis caused by atopic dust mite allergens 5. Infertile women must ensure they do not become pregnant during the treatment period 6. Age must be between 5 and 60 years old
Exclusion criteria
1. Allergic to the excipients of Arrogel (aluminum hydroxide) or the rescue medication epinephrine 2. Suffering from respiratory system diseases other than stable asthma 3. Pulmonary dysfunction (NYHA grade II or above, or FeV1 \< 70%) or having irreversible pathological changes in the reactive organs such as emphysema or bronchiectasis 4. Severe acute or chronic diseases (including malignant diseases), inflammation and fever 5. Multiple sclerosis 6. Immune system diseases (autoimmune diseases, immune diseases caused by antigen-antibody complexes, immune deficiencies, etc.) 7. Active pulmonary tuberculosis 8. Severe mental disorders 9. Obvious cardiac dysfunction 10. Patients who have received immunotherapy within the last 1 years (subcutaneous injection or sublingual administration of allergen-specific immunotherapy, etc.) 11. Patients who used experimental drugs or participated in other clinical studies within 30 days before treatment 12. Patients who received IgE monoclonal antibody (mAb) treatment in the past 4 months 13. Patients taking beta-blockers 14. Patients who have insufficient understanding of the trial 15. Patients whose age is not between 5 years old and 65 years old 16. Patients who are pregnant or breastfeeding during the study period, or have plans to get pregnant 17. Patients who cannot undergo tonsil injection due to acute or chronic tonsillitis, small tonsils, previous tonsillectomy, overly sensitive pharyngeal reflex and inability to cooperate with treatment 18. Patients with aphthous stomatitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CSMS | Before treatment (baseline) and at 1, 2, 3, 6, 12, 24, and 36 months after treatment. | combined symptom and medication score |
| adverse event | 30 minutes after each treatment (at the 0th, 1st, 2nd, 6th, 12th, 18th and 24th months). | Observe adverse events and classify them according to the World Allergy Organization (WAO) subcutaneous immunotherapy reaction classification system. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of Key Serum Cytokines | Before treatment (baseline) and at 6, 12, 24, and 36 months after treatment. | — |
| Concentration of Serum Immune Globulins | Before treatment (baseline) and at 6, 12, 24, and 36 months after treatment. | — |
| Visual Analog Scale (VAS) | Before treatment (baseline) and at 1, 2, 3, 6, 12, 24, and 36 months after treatment. | Pain perception of allergy symptoms during treatment will be evaluated using a scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates maximum pain. |
| ARCT | At 1, 2, 3, 6, 12, 24, and 36 months after treatment. | The Allergic Rhinitis Control Test Questionnaire |
| miniRQLQ | Before treatment (baseline) and at 1, 2, 3, 6, 12, 24, and 36 months after treatment. | mini Rhinoconjunctivitis Quality of Life Questionnaire |
| Proportion of T Cell Differentiation | Before treatment (baseline) and at 6, 12, 24, and 36 months after treatment. | — |
| Absolute Value and Percentage of Blood Leukocytes | Before treatment (baseline) and at 6, 12, 24, and 36 months after treatment. | — |
Countries
China
Contacts
Primary ContactYu Xu, Doctor
Outcome results
None listed