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

August 25, 2024 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • The Second Affiliated Hospital, Zhejiang University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mometasone furoate/Budesonide nasal with/without Budesonide/Formoterol group

Treatment based on patient symptoms includes:

Mometasone furoate 4 sprays daily (qd) or Budesonide nasal spray 2 sprays twice daily ;Budesonide/Formoterol 160/5 µg or 320/5 µg, inhaled twice daily.
Drug: conventional medication
Use conventional medication as needed based on the patient's condition.
conventional medication combined with Qipian® treatment group.

Treatment based on patient symptoms includes:

Mometasone furoate 4 sprays daily (qd) or Budesonide nasal spray 2 sprays twice daily； Budesonide/Formoterol 160/5 µg or 320/5 µg, inhaled twice daily; Qipian® 4 tablets, taken orally three times daily.
Drug: conventional medication
Use conventional medication as needed based on the patient's condition.
Drug: Bacillus clausii tablets（Qipian®）
Take 4 tablets (0.3 mg each) orally three times daily.
Other Names:
  • Use conventional medication as needed based on the patient's condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks
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.
12 weeks
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.
12 weeks
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
12 weeks
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.
12 weeks
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.
12 weeks
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
12 weeks
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
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Study Chair: Huiying Wang, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

July 31, 2024

Study Completion (Actual)

July 31, 2024

Study Registration Dates

First Submitted

August 13, 2024

First Submitted That Met QC Criteria

August 25, 2024

First Posted (Actual)

August 27, 2024

Study Record Updates

Last Update Posted (Actual)

August 27, 2024

Last Update Submitted That Met QC Criteria

August 25, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-0477

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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