Clinical trial NCT06573164: Allergic Rhinitis With/Without Asthma: Pre- and Post-Qipian Analysis
Official title: The Clinical Indexes and Efficacy of Qi-pian in Patients With Allergic Rhinitis With or Without Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhinitis, Allergic
Asthma
Keywords: Rhinitis
Asthma
Qipian
Immunoglobulin
cytokine
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primarily young and middle-aged adults with good adherence to treatment, who can follow prescribed medication regimens and attend regular follow-up appointments. The study will assess whether adding Qipian® to conventional medication provides additional benefits.

Brief summary: Allergic rhinitis and asthma are common respiratory diseases. Qipian® is a Chinese medicine made from three types of bacteria, used to treat these conditions. This study will retrospectively analyze the effects of adding Qipian® to the regular treatment for patients with allergic rhinitis, with or without asthma. Patients meeting the Allergic Rhinitis and its Impact on Asthma（ARIA） and Global Initiative for Asthma（GINA） diagnostic criteria were divided into two groups: one receiving standard drug treatment, and the other receiving standard treatment plus Qipian®. The study will compare clinical symptoms and relevant blood markers before and after treatment to see if adding Qipian® leads to better outcomes than the standard treatment alone.This study aims to determine how Qipian® benefits patients with rhinitis and asthma and its effect on related serum indicators, helping to explore its role in allergic respiratory diseases.

Detailed description: Allergic rhinitis and asthma are common chronic respiratory diseases, with rising prevalence each year. Bacterial lysates (BLs) are a potential treatment option that has been used for over 100 years. Qipian® is a Chinese medication containing extracts from three types of bacteria, used to treat chronic respiratory diseases. It effectively alleviates symptoms and improves the immune system. This study will retrospectively analyze the clinical efficacy of adding Qipian® to the conventional drug treatment in patients with allergic rhinitis with or without asthma. Patients diagnosed with rhinitis and asthma according to ARIA and GINA guidelines were included in the study. They will be divided into two groups based on their treatment regimen: a conventional drug treatment group and a conventional drug plus Qipian® treatment group. Clinical symptoms and relevant serum markers were collected to assess changes before and after treatment, and to determine whether the addition of Qipian® results in more significant improvements compared to the conventional drug treatment group. This will help determine the benefits of Qipian® for patients with rhinitis, with or without asthma, in terms of clinical symptoms and serum indicators, and further explore its role in allergic respiratory diseases.

Eligibility criteria: Inclusion Criteria:

* Patients with rhinitis who meet the ARIA (Allergic Rhinitis and Its Impact on Asthma) guidelines.
* Patients with asthma who meet the GINA (Global Initiative for Asthma) guidelines.

Exclusion Criteria:

* Patients undergoing combined dust mite-specific immunotherapy
* Patients undergoing combined treatment with biologics, including omalizumab, dupilumab, or mepolizumab.
* Patients undergoing combined treatment with small molecule drugs, including upadacitinib, abrocitinib, baricitinib, and other JAK inhibitors.
* Patients who are unwilling to comply with treatment, are unable to adhere to regular medication schedules, and do not attend follow-up appointments.

Primary outcomes:
measure: Total Nasal Symptom Score (TNSS)
timeFrame: 12 weeks
measure: Asthma Control Test（ACT）
timeFrame: 12 weeks
measure: Concentration of immunoglobulin E (IgE)
timeFrame: 12 weeks
measure: Concentration of immunoglobulin A (IgA)
timeFrame: 12 weeks
measure: Concentration of immunoglobulin G (IgG)
timeFrame: 12 weeks
measure: Concentration of Interleukin-4 (IL-4)
timeFrame: 12 weeks
measure: Concentration of Interleukin-13 (IL-13)
timeFrame: 12 weeks
measure: Concentration of Interleukin-10 (IL-10)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
name: Huiying Wang
role: STUDY_CHAIR
References: