REspiratory diSEAse cohoRt Studies of CHinese Medicine for Asthma (RESEARCH- Asthma)

The purpose of this study is to define the standard use of TCM treatment regimen as the TCM cohort group and the non-TCM cohort group of those who use conventional Western medicine treatment without the standard TCM treatment regimen through a multi-center, large-sample prospective cohort study design. To evaluate the clinical efficacy and safety of TCM treatment regimens in the treatment of bronchial asthma, and to provide high-quality evidence for the promotion and application of TCM syndrome differentiation treatment in bronchial asthma.

Study Overview

• Status: Not yet recruiting
• Conditions: Bronchial Asthma

Detailed Description

Bronchial asthma is characterized by chronic inflammation of the airways, which is often recurrent, long-lasting and difficult to cure. Clinical studies have confirmed that the clinical symptoms and quality of life of asthma patients have been significantly improved after TCM intervention. However, most of the current clinical research methods on asthma are small-sample and RCT studies, resulting in insufficient demonstration of efficacy, and there is an urgent need to carry out multi-center, large-sample, high-quality real-world studies in order to obtain higher quality evidence-based medical evidence.

This is a multi-center, large-sample prospective cohort study, which will evaluate the clinical efficacy and safety of TCM treatment regimens in the treatment of bronchial asthma, and provide high-quality evidence for the promotion and application of TCM syndrome differentiation therapy in bronchial asthma. The cohort study will enroll 1508 patients, and the standard use of TCM treatment regimen will be set as the TCM cohort group, and those who will use the conventional treatment of Western medicine but not the standard TCM treatment regimen will be the non-TCM cohort group. The asthma control rate was the main outcome index, and the asthma control questionnaire (ACQ), asthma quality of life score (AQLQ), clinical symptom and sign score, lung function, exhaled nitric oxide, induced sputum inflammation phenotype, glucocorticoid dose, and fast-acting β2 agonist dose were the secondary outcome indicators. Follow-up was conducted every 3 months for 1 year.

• Study Type: Observational
• Enrollment (Estimated): 1508

Contacts and Locations

• Study Contact: Name: Hai-bin Yu, Ph.D; Phone Number: +86 13526671773; Email: wwz1231125@163.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China
      • The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
      • Contact: Hai-bin Yu, Ph.D; Phone Number: +86 13526671773; Email: wwz1231125@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who are eligible for a diagnosis of bronchial asthma disease

Description

Inclusion Criteria:

1. Patients who meet the diagnosis of bronchial asthma;
2. Age 18~80 years old;
3. Have not participated in other clinical studies within 1 month before enrollment;
4. Voluntarily participate in the study and sign the informed consent form.

Exclusion Criteria:

1. Patients with respiratory failure and mechanical ventilation during acute asthma exacerbation;
2. Delirium, impaired consciousness, dementia, and various mental illnesses;
3. Patients with other lung diseases such as COPD, lung abscess, cystic fibrosis, bronchiectasis, etc., and severe liver and kidney diseases;
4. Patients with neuromuscular diseases that affect respiratory motor function and are unable to complete the six-minute walk test;
5. Pregnant and lactating patients;
6. Those who are participating in other clinical trials.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Traditional Chinese Medical cohort; The standardized use of TCM treatment regimen was regarded as an exposure factor, and the treatment methods of the enrolled patients were defined and grouped: patients who took medication continuously for more than 3 months per year, or who took medication intermittently for more than 6 months in the total time of the year, were in the exposure group.
Non Traditional Chinese Medical cohort; Those who used conventional Western medicine treatment without using standardized Chinese medicine treatment regimen were in the non-exposure group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asthma control rate	According to the composite indicators such as symptoms, medication and pulmonary function test results, the clinical control level of asthma was divided into complete control, partial control and uncontrolled, and the asthma control rate of patients was evaluated according to the clinical control level of asthma.	The follow-up period was followed up every 3 months for 1 year.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of exacerbations	The number of acute attacks is mainly recorded	The follow-up period was followed up every 3 months for 1 year.
Asthma exacerbation severity	Worsening lung function during asthma attacks is characterized by decreased expiratory flow, and the severity of the exacerbation can be graded by the patient's symptoms, lung function, and arterial blood gas analysis.According to the frequency of daytime and nighttime asthma attacks and pulmonary function test results, the patients were divided into 4 grades, namely: 1 intermittent attack; 2 mild persistent; 3 moderate persistent and 4 severe persistent.The severity of the asthma attack was assessed using a rating scale.	The follow-up period was followed up every 3 months for 1 year.
Change in severity of chronic persistent disease	Although the patient does not have an acute attack of asthma, there are still symptoms such as wheezing, cough, chest tightness and other symptoms with different frequency and degrees for a long time, which may be accompanied by decreased pulmonary ventilation function. The severity of chronic persistent asthma can be classified into four levels: intermittent, mildly persistent, moderately persistent, and severely persistent, according to the frequency of daytime and nighttime asthma symptoms and the results of pulmonary function tests.The severity of the asthma attack was assessed using a rating scale.	The follow-up period was followed up every 3 months for 1 year.
The dose used by glucocorticoids	Corticosteroids are the drug of choice for long-term asthma treatment. The vast majority of patients with chronic persistent asthma are well controlled by inhaling low-dose corticosteroids (equivalent to 400 micrograms of budesonide per day).	The follow-up period was followed up every 3 months for 1 year.
Rapid-acting beta2 agonists use drugs and doses	Beta2 agonists are asthma drugs that stimulate beta2 receptors distributed on airway smooth muscle to produce bronchodilating effects. These drugs are bronchodilators and are the drugs of choice for acute asthma attacks (airway spasm), which can quickly improve symptoms such as dyspnea, cough, etc. If given by inhalation, salbutamol 100-200mcg or terbutaline 250-500mcg at a time and repeat every 20 minutes if necessary.	The follow-up period was followed up every 3 months for 1 year.
Asthma Control Test (ACT) score	The ACT score correlates well with the level of asthma control in patients as assessed by experts. The questionnaire included wheezing symptoms, activity limitations, frequency of use of rescue medication, patients' asthma control and self-assessment, with a total of 5 items. Each item is scored on a scale of 1~5, with a total score of 5~25 points, and the higher the score, the better the control of asthma symptoms.	The follow-up period was followed up every 3 months for 1 year.
Asthma Control Questionnaire (ACQ)	The ACQ questionnaire will measure the quality of life associated with asthma. The ACQ questionnaire consists of either 7 questions (ACQ-7) or 6 questions (ACQ-6). In questions 1-6, patients recalled their experiences from the previous 7 days and answered using a scale of 7 (from 0 = complete control to 6 = very poor control). The seventh question refers to % FEV1 of the reference value and must be completed by the staff of the website. The questionnaire score is the average of either 7 responses (ACQ-7) or 6 responses (ACQ-6). The score is interpreted as follows: 0.75 or less: adequate asthma control. From 0.75 to 1.50: partially controlled asthma. Over 1.50: inadequate asthma control.	The follow-up period was followed up every 3 months for 1 year.
Asthma Quality of Life Score (AQLQ)	It is used to measure the severity of asthma and its impact on patients' quality of life, including 35 items in 5 aspects. The AQLQ score relates to activity limitation, asthma symptoms, psychological condition, response to stimuli, and concern for one's own health, and the form assesses the degree of impact of asthma on a 7-point scale, with a maximum impact of 1 point and no impact of 7 points.	The follow-up period was followed up every 3 months for 1 year.
Anxiety Self-Assessment Form (SAS)	It included 20 items reflecting the subjective feelings of anxiety, and each item was divided into four levels according to the frequency of symptoms, including 15 positive scores and 5 reverse scores. The cut-off value for the standard deviation of SAS is 50 points, with higher scores indicating more severe symptoms of anxiety.Among them, 50 to 59 are classified as mild anxiety, 60 to 69 are classified as moderate anxiety, and more than 69 are severe anxiety.	The follow-up period was followed up every 3 months for 1 year.
Depression Self-Rating Scale (SDS)	The SDS Depression and Anxiety Test Form contains 20 items, which are scored on a 4-point scale, with 1 indicating occasional symptoms, 2 indicating sometimes symptoms, 3 indicating frequent symptoms, and 4 indicating persistent symptoms. A rough score is obtained by adding the scores in each of the 20 items. Multiply the rough score by 1.25 and then take the integer part to get the standard score. Generally speaking, depression with a total score of less than 52 is normal, 53-62 is mild depression, 63-72 is moderate depression, and 72 or more is severe depression. The higher the score, the more severe the symptoms.	The follow-up period was followed up every 3 months for 1 year.
Pulmonary function	FVC, FEV1, FEV1 % of the estimated value, FEV1/FVC were mainly used for evaluation.	The follow-up period was followed up every 3 months for 1 year.
Exhaled nitric oxide (FeNO)	The measuring instrument uses an exhaled nitric oxide measurement system to record the FeNO value of the patient.	The follow-up period was followed up every 3 months for 1 year.

Collaborators and Investigators

• Sponsor: Henan University of Traditional Chinese Medicine
• Collaborators: Peking University People's Hospital; The First Affiliated Hospital of Zhengzhou University; The First Affiliated Hospital of Henan University of Traditional Chinese Medicine; Tianjin University of Traditional Chinese Medicine; The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine; The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine; First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine; The Third Affiliated Hospital of Henan University of Traditional Chinese Medicine; Hebei Provincial Hospital of Traditional Chinese Medicine
• Investigators: Study Chair: Jian-sheng Li, Professor, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: January 3, 2024
• First Submitted That Met QC Criteria: April 15, 2024
• First Posted (Actual): April 18, 2024

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Bronchial asthma; Cohort studies; Asthma control rate; Number of acute attacks
• Additional Relevant MeSH Terms: Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: TCM for Asthma Cohort

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO