Microbial Study of Sublingual Immunotherapy Spray in Patients With Allergic Rhinitis

NCT06741787 | Not Yet Recruiting

• 1 other identifier: 2023-SR-961
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Rhinitis, Allergic

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Patients desensitized by sublingual spray

Oraltekzc®️(Canis familiari), Oraltek®️(Felis domesticus), Oraltek®️(Alternaria alternata), dosage form: sublingual spray.

Drug: Patients desensitized by sublingual spray

Interventions

Patients desensitized by sublingual spray DRUG

Drug: Oraltekzc®️(Canis familiari), Oraltek®️(Felis domesticus), Oraltek®️(Alternaria alternata), dosage form: sublingual spray.

Patients desensitized by sublingual spray

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

elbow venous blood: 2ml, feces: 5ml, saliva:2ml, tonsil microorganism:2ml, nasal exfoliated cells:2ml, nasal microorganism:2ml.

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Lei Cheng, PhD

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

Central Study Contacts

Lei Cheng, PhD

CONTACT

13776620807; chenglei@jsph.org.cn

Yanbing Chen, master

CONTACT

15851875990; 1163259065@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: December 19, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 19, 2024

Record last verified: 2024-12

Locations

CN (1)