Microbial Study of Sublingual Immunotherapy Spray in Patients With Allergic Rhinitis

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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.

Eligibility

Primary outcome measure(s)

• 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 sites (1)

More The First Affiliated Hospital with Nanjing Medical University trials in China

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