A Study to Assess Jia Wei Yang He Formula as a Plus Therapy in the Treatment of Persistent Asthma

Study Overview
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Brief Summary
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Investigators aimed to assess Jia Wei Yang He Formula as a plus therapy in the treatment of persistent asthma and to explore Airway Microbiome variation of Asthma by Traditional Chinese Medicine treatment

Detailed Description
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Asthma is a common chronic inflammatory respiratory disease, patients showed high airway reactivity, and the clinical manifestations of recurrent wheezing, shortness of breath, chest tightness or cough with wheezing dyspnea mainly for a breath. Although many studies have shown that viral infections may be an important cause of asthma seasonal attacks. However, more and more studies have shown that bacterial infection is an important risk factor for asthma. Haemophilus influenzae, Moraxella Mora bacteria infection may increase the risk of asthma by a research report. Chinese medicine decoction, as a common treatment for asthma, can significantly alleviate seasonal attacks and reduce the number of acute attacks. Research shows that Chinese medicine has widely immunomodulatory effects and imbalance of immune system in patients with asthma control, improve the cellular immunity of patients with airway and defense function, significantly reduced asthma attacks of which induced by upper airway infection or chronic persist asthma. This study will be conducted for 4 weeks of standard anti-asthma treatment plus Jia Wei Yang He Formula for patients.Some patients are not willing to use standard treatment such as inhaled corticosteroids and long-acting β-adrenoceptor agonists because of side effects. We will provide these patients free JWYH formula after the efficacy of the JWYH is validated and the subsequent results are considered exploratory. Participants will undergo a physical examination, lung function, blood and sputum collection and all induced sputum samples will be detected by 16S ribosomal RNA (16S rRNA) sequencing and analyzed for microbial bioinformatics. To study whether there is association between the efficacy of Jia Wei Yang He Formula and the changes in microbiota composition.

Official Title
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Clinical Assessment of Jia Wei Yang He Formula as a Plus Therapy in the Treatment of Persistent Asthma and Airway Microbiome Exploration Research

Conditions
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Bronchial Asthma

Intervention / Treatment
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* Drug: Jia Wei Yang He granule
* Drug: Jia Wei Yang He granule Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient diagnosed with chronic persistent asthma Annual uncontrollable time ≥ 3 months Patients who have given written informed consent Exclusion Criteria: History of upper upper/lower respiratory infection in the previous 1 months History of long-term controller medication use for asthma (oral corticosteroid or intravenous corticosteroids therapy) within the preceding 1 months History of antibiotic use in the previous 1 months History of life-threatening asthma History of chronic lung diseases other than asthma, including but not limited to chronic obstructive pulmonary disease, bronchiectasis, emphysema, tuberculosis, sarcoidosis, pulmonary fibrosis, lung cancer, etc History of serious disease of the heart and cerebrovascular disease History of severe liver or renal dysfunction or disease History of severe disease in the hematopoietic system History of immunodeficiency (including, but not limited to, HIV positive detection, or other acquired or congenital immunodeficiency disease, or organ transplant history) History of any other condition (such as known drug or alcohol abuse or psychiatric disorder) which, in the opinion of the investigator, may preclude the patient from following and completing the protocol Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device (other than the investigational product used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study History of allergies to the component of the investigated drugs Smoking within the past year Contraindication to induced sputum collection method on history or examination Any serious medical condition which, in the opinion of the Investigator, would pose a significant risk to the patient or interfere with the interpretation of safety, efficacy, or pharmacodynamic data

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All treatment group received a standard anti-asthma treatment plus Jia Wei Yang He Formula on study entry, and the control group received Jia Wei Yang He Formula placebo instead.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Group<br>80 participants will take oral therapy of 9.25 g Jia Wei Yang He granule Placebo twice a day for 28 consecutive days and also standard therapy of inhaled corticosteroid or beta2-agonist. | Drug: Jia Wei Yang He granule Placebo<br>* Made from 1/20 doses which has certain taste, but no therapeutic effect<br>* Other names: Placebo;|
| Experimental: High dose Treatment Group<br>Participants in high Jia Wei Yang He formula group will receive Jia Wei Yang He granule 18.5g twice a day for 28 consecutive days and also standard therapy of inhaled corticosteroid or beta2-agonist. | Drug: Jia Wei Yang He granule<br>* This is an empirical traditional Chinese medicine compound used in the treatment of asthma for a long time<br>* Other names: Jia Wei Yang He Formula;|
| Experimental: Low dose Treatment Group<br>Participants in high Jia Wei Yang He formula group will receive Jia Wei Yang He granule 9.25g twice a day for 28 consecutive days and also standard therapy of inhaled corticosteroid or beta2-agonist. | Drug: Jia Wei Yang He granule<br>* This is an empirical traditional Chinese medicine compound used in the treatment of asthma for a long time<br>* Other names: Jia Wei Yang He Formula;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Control Test Score variation | Measured the change from Baseline to the end of treatment | Baseline and 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Airway microbial diversity | Measured by 16S rRNA sequencing of induces sputum | Baseline, 2 weeks and 4weeks | 
| Pulmonary function tests | Measured the change from Baseline to the end of treatment | Baseline and 4 weeks | 
| Fractional exhaled nitric oxide (FeNO) | Measured the change from Baseline to the end of treatment of exhaled nitric oxide | Baseline and 4 weeks | 
| Morning and evening Peak Expiratory Flow (PEF) | Measured the change from Baseline to the end of treatment | Measured during the 4 weeks treatment period | 
| Cytokine levels of serum | Measured the change from Baseline to the end of treatment | Baseline and 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bronchial Asthma，TCM，microorganism