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NCT Number: NCT06573164

Allergic Rhinitis With/Without Asthma: Pre- and Post-Qipian Analysis

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.

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Key information

Conditions

Rhinitis, Allergic Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Lung Diseases Lung Diseases, Obstructive Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Rhinitis

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Bacillus clausii tablets（Qipian®）

Drug

Take 4 tablets (0.3 mg each) orally three times daily.

Other names: Use conventional medication as needed based on the patient's condition.

conventional medication

Drug

Use conventional medication as needed based on the patient's condition.

Primary outcomes

  1. Total Nasal Symptom Score (TNSS)

    Time frame: 12 weeks

    A primary indicator used to assess nasal symptom in patients with rhinitis.The minimum and maximum values are 0 and 21, respectively, and higher values are associated with worse symptom control.

  2. Asthma Control Test（ACT）

    Time frame: 12 weeks

    It is a tool used to assess the control of asthma symptoms and evaluate how well asthma is managed.the minimum and maximum values are 5 and 25, respectively, and higher values are associated with better symptom control.

  3. Concentration of immunoglobulin E (IgE)

    Time frame: 12 weeks

    Elevated IgE levels are commonly associated with allergic conditions, such as allergic rhinitis, asthma, and atopic dermatitis.IgE levels can be used to monitor the effectiveness of allergy treatments and to assess changes in allergen exposure or disease severity.The normal IgE range is < 100IU/ml.

  4. Concentration of immunoglobulin A (IgA)

    Time frame: 12 weeks

    An antibody that plays a crucial role in the immune function of mucous membranes.It is primarily found in secretions such as saliva, tears, and mucus, and helps protect mucosal surfaces from infection.The normal IgA range is between 1.0-4.2g/l

  5. Concentration of immunoglobulin G (IgG)

    Time frame: 12 weeks

    IgG helps neutralize toxins and pathogens such as bacteria and viruses. It activates the complement system, which helps to destroy pathogens.Normal IgG ranges from 8.6-17.4g/l.

  6. Concentration of Interleukin-4 (IL-4)

    Time frame: 12 weeks

    IL-4 stimulates B cells to produce immunoglobulin E (IgE), which is crucial in allergic responses.It supports the differentiation of T-helper cells into Th2 cells, which are involved in promoting allergic reactions and immune responses to parasites. IL-4 can inhibit the Th1 response, which is involved in cell-mediated immunity and responses to intracellular pathogens.The normal range of IL-4 is 0.0-12.9 pg/ml.

  7. Concentration of Interleukin-13 (IL-13)

    Time frame: 12 weeks

    IL-13 is crucial in the development of allergic inflammation and asthma. It promotes the production of IgE and supports the differentiation of Th2 cells, which contribute to allergic responses.It helps in the regulation of mucus production and epithelial cell function, which can affect conditions like asthma and rhinitis.L-13 is involved in tissue remodeling and fibrosis, particularly in the lungs, contributing to the development of chronic asthma and other fibrotic diseases.IL-13 can have anti-inflammatory effects in certain contexts, modulating the immune response and tissue repair processes.The normal range of IL-13 is 0.0-17.3 pg/ml

  8. Concentration of Interleukin-10 (IL-10)

    Time frame: 12 weeks

    IL-10 inhibits the production of pro-inflammatory cytokines by immune cells, helping to reduce and control inflammation.It plays a role in maintaining immune system balance by preventing excessive immune responses and limiting damage to tissues. IL-10 helps promote tolerance to self-antigens and to non-pathogenic antigens, which is important in preventing autoimmune diseases and allergies.It affects the activity of various immune cells, including macrophages and T cells, to help maintain immune homeostasis.The normal range of IL-10 is 0.0-5.9 pg/ml

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

The Clinical Indexes and Efficacy of Qi-pian in Patients With Allergic Rhinitis With or Without Asthma

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 27, 2024
Registry last updated
Aug 27, 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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