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NCT Number: NCT06741787

Microbial Study of Sublingual Immunotherapy Spray in Patients With Allergic Rhinitis

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

Location contact

Lei Cheng, PhD

CONTACT

[email protected]

13776620807 ext. 0086

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Patients desensitized by sublingual spray

Drug

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

Primary outcomes

  1. Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)

    Time frame: 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

  2. Visual analogue scale (VAS)

    Time frame: 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.

  3. Total Nasal Symptom Score (TNSS)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lei Cheng, PhD

CONTACT

[email protected]

13776620807 ext. 0086

Yanbing Chen, master

CONTACT

[email protected]

15851875990 ext. 0086

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 19, 2024
Registry last updated
Dec 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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