Microbial Study of Sublingual Immunotherapy Spray in Patients With Allergic Rhinitis

Microbial Characterization in Patients With Allergic Rhinitis Before and After Sublingual Immunotherapy Spray

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rhinitis, Allergic
• Intervention / Treatment: Drug: Patients desensitized by sublingual spray

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Lei Cheng, PhD; Phone Number: 0086 13776620807; Email: chenglei@jsph.org.cn
• Study Contact Backup: Name: Yanbing Chen, master; Phone Number: 0086 15851875990; Email: 1163259065@qq.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • The First Affiliated Hospital of Nanjing Medical University
      • Contact: Lei Cheng, PhD; Phone Number: 0086 13776620807; Email: chenglei@jsph.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with allergic rhinitis in the Department of Otolaryngology of the First Affiliated Hospital of Nanjing Medical University and selected sublingual spray desensitization.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients desensitized by sublingual spray; Oraltekzc®️(Canis familiari), Oraltek®️(Felis domesticus), Oraltek®️(Alternaria alternata), dosage form: sublingual spray.	Drug: Patients desensitized by sublingual spray; Drug: Oraltekzc®️(Canis familiari), Oraltek®️(Felis domesticus), Oraltek®️(Alternaria alternata), dosage form: sublingual spray.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)	Patients were scored by questionnaire before and after treatment, and the change in score before and after treatment was the primary outcome measure	2024.2-2026.7
Visual analogue scale (VAS)	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.	2024.2-2026.7
Total Nasal Symptom Score (TNSS)	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.	2024.2-2026.7

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Investigators: Study Director: Lei Cheng, PhD, The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: January 22, 2024
• First Submitted That Met QC Criteria: December 18, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Nose Diseases; Otorhinolaryngologic Diseases; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: 2023-SR-961

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No