Rhinitis, AllergicNCT06573164
Allergic Rhinitis With/Without Asthma: Pre- and Post-Qipian Analysis
An observational study of Rhinitis, Allergic and Asthma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Rhinitis, Allergic, Asthma
- What is being tested?
- Bacillus clausii tablets（Qipian®） and conventional medication
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
About this study
Official title: 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.
Read the 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.
- Conditions
- Rhinitis, Allergic, Asthma
- Being tested
- Bacillus clausii tablets（Qipian®）, conventional medication
- Keywords
- Rhinitis, Asthma, Qipian, Immunoglobulin, cytokine
- Medical subject headings
- Rhinitis, Allergic, Asthma, Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacillus clausii tablets（Qipian®）Drug
Also called Use conventional medication as needed based on the patient's condition.
Take 4 tablets (0.3 mg each) orally three times daily.
conventional medicationDrug
Use conventional medication as needed based on the patient's condition.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Bacillus clausii tablets（Qipian®）; Drug: conventional medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start1 Jan 2024
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis, AllergicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huiying Wang, Study chair, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573164
- Sponsor's protocol ID
- 2024-0477
- Status last verified
- Aug 2024
- First submitted
- 13 Aug 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Indexes and Efficacy of Qi-pian in Patients With Allergic Rhinitis With or Without Asthma
- ClinicalTrials.gov ID
- NCT06573164
- Acronym / sponsor ID
- 2024-0477
- Conditions
- Rhinitis, Allergic, Asthma
- Keywords
- Rhinitis, Asthma, Qipian, Immunoglobulin, cytokine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 27 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mometasone furoate/Budesonide nasal with/without Budesonide/Formoterol group | – | Drug: conventional medicationTreatment 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. |
| conventional medication combined with Qipian® treatment group. | – | Drug: Bacillus clausii tablets（Qipian®）, Drug: conventional medicationTreatment 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bacillus clausii tablets（Qipian®）Also: Use conventional medication as needed based on the patient's condition.Take 4 tablets (0.3 mg each) orally three times daily. | Drug | conventional medication combined with Qipian® treatment group. |
| conventional medicationUse conventional medication as needed based on the patient's condition. | Drug | Mometasone furoate/Budesonide nasal with/without Budesonide/Formoterol group, conventional medication combined with Qipian® treatment group. |
Primary outcome
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.
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.
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.
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
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.
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.
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huiying Wang study chair
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhinitis, Allergic and Asthma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Nasal Symptom Score (TNSS) (time frame: 12 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.