Microbial Study of Sublingual Immunotherapy Spray in Patients With Allergic Rhinitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Patients desensitized by sublingual spray.
- Who it may be relevant to
- Registry conditions: Rhinitis, Allergic. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Microbial Characterization in Patients With Allergic Rhinitis Before and After Sublingual Immunotherapy Spray
Overview
The incidence of allergic rhinitis (AR) in Chinese adults was reported to be as high as 24.1% and 16.8% in children. The current symptomatic treatment has the disadvantage of poor efficacy and cannot change the natural course of the disease. Allergen immunotherapy (AIT) is the only causative treatment approved by the WHO, bringing a new option to patients with allergic diseases. The quality of allergen preparations is critical to the diagnosis and treatment of the disease, emphasizing the need for standardized preparations, and AIT treatment in the early stages of the disease may change the long-term progression of the disease. Recent studies have reported that the microbiome of patients with different efficacy of desensitization therapy is different and may be correlated with the clinical symptoms of patients, but no prospective studies have been reported.
Interventions
- Drug Patients desensitized by sublingual spray
Drug: Oraltekzc®️(Canis familiari), Oraltek®️(Felis domesticus), Oraltek®️(Alternaria alternata), dosage form: sublingual spray.
Primary outcome measures
- Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) [Time frame: 2024.2-2026.7]
- Visual analogue scale (VAS) [Time frame: 2024.2-2026.7]
- Total Nasal Symptom Score (TNSS) [Time frame: 2024.2-2026.7]
Eligibility criteria
Inclusion criteria
- Adult patients (18-65 years).
- Patients with canis familiari/felis domesticus/alternaria alternata allergic rhinitis were diagnosed based on clinical history and positive dust mite sensitization tests (skin prick test and/or specific IgE).
- Patients who visited the Department of Otolaryngology of the First Affiliated Hospital of Nanjing Medical University and selected sublingual spray desensitization.
Exclusion criteria
- Patients who refused to accept specimen and questionnaire collection.
- Patients who had nasal diseases other than allergic rhinitis, such as nasal papilloma and nasal malignant tumor.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- The First Affiliated Hospital of Nanjing Medical University — Nanjing
Identifiers
NCT: NCT06741787 · 2023-SR-961