Clinical trial NCT06373692: REspiratory diSEAse cohoRt Studies of CHinese Medicine for Asthma (RESEARCH- Asthma)
Official title: REspiratory diSEAse cohoRt Studies of CHinese Medicine for Asthma (RESEARCH- Asthma)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Bronchial Asthma
Keywords: Bronchial asthma
Asthma control rate
Number of acute attacks
Cohort studies
Lead sponsor: Henan University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
name: Tianjin University of Traditional Chinese Medicine
name: Third Affiliated Hospital of Henan University of Traditional Chinese Medicine
name: Hebei Provincial Hospital of Traditional Chinese Medicine
name: Peking University People's Hospital
name: The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
name: The First Affiliated Hospital of Zhengzhou University
name: Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
name: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
First posted: 2024-04-18
Enrollment: 1508
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are eligible for a diagnosis of bronchial asthma disease

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Asthma control rate
timeFrame: The follow-up period was followed up every 3 months for 1 year.
Secondary outcomes:
measure: Number of exacerbations
timeFrame: The follow-up period was followed up every 3 months for 1 year.
measure: Asthma exacerbation severity
timeFrame: The follow-up period was followed up every 3 months for 1 year.
measure: Change in severity of chronic persistent disease
timeFrame: The follow-up period was followed up every 3 months for 1 year.
measure: The dose used by glucocorticoids
timeFrame: The follow-up period was followed up every 3 months for 1 year.
measure: Rapid-acting beta2 agonists use drugs and doses
timeFrame: The follow-up period was followed up every 3 months for 1 year.
measure: Asthma Control Test (ACT) score
timeFrame: The follow-up period was followed up every 3 months for 1 year.
measure: Asthma Control Questionnaire (ACQ)
timeFrame: The follow-up period was followed up every 3 months for 1 year.
measure: Asthma Quality of Life Score (AQLQ)
timeFrame: The follow-up period was followed up every 3 months for 1 year.
measure: Anxiety Self-Assessment Form (SAS)
timeFrame: The follow-up period was followed up every 3 months for 1 year.
measure: Depression Self-Rating Scale (SDS)
timeFrame: The follow-up period was followed up every 3 months for 1 year.
measure: Pulmonary function
timeFrame: The follow-up period was followed up every 3 months for 1 year.
measure: Exhaled nitric oxide (FeNO)
timeFrame: The follow-up period was followed up every 3 months for 1 year.
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
state: Henan
Study officials:
affiliation: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
name: Jian-sheng Li, Professor
role: STUDY_CHAIR
References: