Microbial Study of Sublingual Immunotherapy Spray in Patients With Allergic Rhinitis

Not yet recruiting

• Conditions: Rhinitis, Allergic
• Interventions: Drug: Patients desensitized by sublingual spray

• Registration Number: NCT06741787
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-22
• Status Verified: 2024-12
• Study Start: 2024-12
• Study First Submitted QC: 2024-12-18
• Last Update Submitted: 2024-12-18
• Study First Posted: 2024-12-19
• Last Update Posted: 2024-12-19
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients desensitized by sublingual spray	Patients desensitized by sublingual spray	Oraltekzc®️(Canis familiari), Oraltek®️(Felis domesticus), Oraltek®️(Alternaria alternata), dosage form: sublingual spray.

Primary Outcome Measures

Name	Time	Method
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)	2024.2-2026.7	Patients were scored by questionnaire before and after treatment, and the change in score before and after treatment was the primary outcome measure
Visual analogue scale (VAS)	2024.2-2026.7	Patients were scored by questionnaire before and after treatment, and the change in score before and after treatment was the primary outcome measure. Range: 0-10. Higher scores reflect more pain and severity.
Total Nasal Symptom Score (TNSS)	2024.2-2026.7	It includes four common nasal symptoms: itching, nasal congestion, sneezing and runny nose. These four symptoms are scored using a "four-point scale," in which the severity of each symptom is rated from 0 to 3. The total score for the entire TNSS score is the sum of the four symptom scores, which range from 0 to 12.

Trial Locations

Locations (1)

The First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China