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

NCT06573164 | Completed

• 1 other identifier: 2024-0477
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Rhinitis, Allergic; Asthma

Keywords

Rhinitis; Asthma; Qipian; Immunoglobulin; cytokine

Outcome Measures

Primary Outcomes (8)

• Total Nasal Symptom Score (TNSS)

  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）

  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)

  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)

  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)

  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)

  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)

  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)

  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

Study Arms (2)

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

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: Bacillus clausii tablets（Qipian®）; Drug: conventional medication

Interventions

Bacillus clausii tablets（Qipian®） DRUG

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

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

conventional medication combined with Qipian® treatment group.

conventional medication DRUG

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

Mometasone furoate/Budesonide nasal with/without Budesonide/Formoterol group; conventional medication combined with Qipian® treatment group.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Rhinitis, Allergic; Asthma; Rhinitis

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Infections; Infections

Study Officials

• Huiying Wang

  2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 27, 2024
• Study Start: January 1, 2024
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: August 27, 2024

Record last verified: 2024-08

Locations

CN (1)