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Microbial Study of Sublingual Immunotherapy Spray in Patients With Allergic Rhinitis

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06741787
Enrollment
100
Registered
2024-12-19
Start date
2024-12-31
Completion date
2026-07-31
Last updated
2024-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rhinitis, Allergic

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.

Interventions

DRUGPatients desensitized by sublingual spray

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

Sponsors

The First Affiliated Hospital with Nanjing Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)2024.2-2026.7Patients 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)2024.2-2026.7Patients 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)2024.2-2026.7It 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.

Countries

China

Contacts

Primary ContactLei Cheng, PhD
chenglei@jsph.org.cn13776620807
Backup ContactYanbing Chen, master
1163259065@qq.com15851875990

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026