Conduct a multi-center, large-sample, randomized controlled clinical study of "winter disease being cared in summer" with Shu Fei Tie prevent recurrence of Asthma and COPD, scientifically evaluate the clinical efficacy and safety of Shu Fei Tie in reducing the recurrence of chronic airway diseases, identify target population, clarify the mechanism of efficacy, and establish a prevention and treatment technology plan for Shu Fei Tie to reduce the recurrence of chronic airway diseases.
Asthma and Chronic obstructive pulmonary disease (COPD) are the most common chronic airway diseases, and their recurrent episodes or acute exacerbations are the main reasons for the decline in patients' quality of life and heavy economic burden. Based on the of "winter disease being cared in summer", traditional Chinese medicine (TCM) has a long history and wide application in preventing and treating the recurrence of chronic air diseases, with obvious advantages of combining TCM and Western medicine. However, there is a lack of integrated TCM and Western medicine technical schemes for chronic airway based on high-level evidence-based evidence. The Shu Fei Tie developed by our project team is a medical institution preparation that has been used clinically for a long. Therefore, this study conducted a multi-center, large-sample, randomized controlled clinical study of the Shu Fei Tie to prevent the recurrence of asthma and COPD. The study subjects were patients in the remission period of asthma (1332 cases) and the stable period of COPD (980 cases) On the basis of treatment guided by the guidelines, the experimental group was given the Shu Fei Tie, and the control group was given a placebo of theu Fei Tie. The treatment started 10 days before the " the first Fu" and was conducted every 10 days, A total of 5 times, Each treatment lasted 6-8 hours, and the follow-up period was 45 weeks, for a total of 3 cycles (3 years). The outcome indicators were the number of acute attacks per year for asthma and the number of acute exacerbations per year for COPD. The secondary outcome indicators for asthma included Asthma Control Test (ACT) score, the Asthma Control Questionnaire (ACQ), and the Asthma Quality of Life Questionnaire (AQLQ). For COPD, the secondary outcome indicators included clinical symptom scores and lung function. This study scientifically evaluated the clinical efficacy and safety of the Shu Fei Tie reducing the recurrence of chronic airway diseases, identified the advantageous population, elucidated the mechanism of efficacy, and established a technical scheme for preventing and treating the recurrence of chronic airway diseases with the Shu Fei Tie.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
2,312
Optimize the extraction process and matrix formulation, and combine the use of traditional Chinese medicine volatile oil and chemical transdermal enhancers to develop adermal patch（Shu Fei Tie）
Shu Fei Tie Placebos are made using substances without active drug ingredients, following the same preparation procedures
The First Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou, Henan, China
Asthma part：Number of acute attacks per year
Record the number of acute attacks per year for each patient, and evaluate the effect of the lung-clearing patch on reducing the number of acute attacks
Time frame: Count once a year for three consecutive years
COPD part：The number of acute exacerbations per year
Record the number of acute exacerbations in patients per year to evaluate the treatment effect of Shu Fei Tie on patients.
Time frame: Count once a year for three consecutive years
COPD part：the interval between successive acute exacerbations
Record relevant information and evaluate the treatment effect of lung soothing patches on patients.
Time frame: at weeks 13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)，Until the first acute exacerbation occurs
COPD part:the number of rehospitalizations within a year
Record relevant information and evaluate the treatment effect of lung soothing patches on patients.
Time frame: Count once a year until the end of the 3-year cycle
Asthma part：Asthma Control Test
ACT includes five questions. Every question will be assessed using a 5-point scale with scores ranging from 5 to 25. The higher the score, the better the symptom control.25 is considered complete control level, 20 \~ 24 is considered good control level, and \<20 is considered non-control level.
Time frame: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)
Asthma part：Asthma Control Questionnaire
The content of ACQ involves the following aspects: asthma-related, symptoms, the use of first-aid drugs, the impact on daily life and lung function test results.The higher the score, the worse the state.
Time frame: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)
Asthma part：Asthma Quality of Life Questionnaire
The asthma quality of life scale (5-point scale-RRB- consists of 35 items, including activity limitation (1-12) , asthma symptoms (13-20) , psychological status (22-26) , response to stimuli (27-31) , concern for one's own health (32-35) . On a 5-point scale, 1 is the worst and 5 is the best.
Time frame: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)
Asthma part：Frequency of anti-inflammatory and analgesic use
Detailed record of the use of treatment drugs, evaluation of treatment effect
Time frame: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)
Asthma part：Disease Control Rate
Based on the disease control situation, the disease control rate is calculated and the efficacy is evaluated.
Time frame: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)
Asthma part：readmission rate
The impact on patient prognosis was evaluated by calculating the number of readmissions.
Time frame: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)
Asthma part：Forced expiratory volume in the first second
FEV1 will be applied to assess pulmonary function
Time frame: Before treatment, at weeks 52, 104, and 156 of treatment
Asthma part：Peak expiratory flow
PEF will be applied to assess pulmonary function
Time frame: Before treatment, at weeks 52, 104, and 156 of treatment
Asthma part：Fractional exhaled nitric oxide
PEF will be used to evaluate the patient's airway inflammation
Time frame: Before treatment, at weeks 52, 104, and 156 of treatment
Asthma part：clinical symptoms and signs questionnaire
Assessment will be performed by clinical symptoms and signs questionnaire. The clinical symptoms to be evaluated in this study include cough, expectoration, chest tightness, gasp and wheezing. A score of 0-3 will be given to every symptom or sign with a higher score indicating a worse conditoin.
Time frame: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)
COPD part：clinical symptoms and signs questionnaire
Assessment will be performed by clinical symptoms and signs questionnaire. The clinical symptoms to be evaluated in this study include cough, phlegm, chest tightness, gasp,shortness of breath, feeble and cyanosis. A score of 0-3 will be given to every symptom or sign with a higher score indicating a worse conditoin.
Time frame: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)
COPD part：mMRC
The modified Medical Research Council (mMRC) scale is a 5-point (0-4) scale based on the severity of dyspnoea. "0" means no dyspnea perception, "4" means severe dyspnea perception.
Time frame: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)
COPD part：CAT
0-40 scores. Scores for each questionnaire item were tallied based on the participant's responses, and if the total score was \>10, the participant needed to be seen by a physician for further testing to determine if they had COPD.
Time frame: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)
COPD part：SGRQ
The evaluation content consists of three parts: respiratory symptoms, activity ability, and disease impact. The questionnaire is calculated using SGRQ software, and the symptom score, activity score, impact score, and total score are obtained separately. The score fluctuates between 0-100, and the quality of life is negatively correlated with the score.
Time frame: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)
COPD part：Forced expiratory volume in the first second
FEV1 will be applied to assess pulmonary function
Time frame: Before treatment, at weeks 52, 104, and 156 of treatment
COPD part：Forced Vital Capacity
FVC will be applied to assess pulmonary function
Time frame: Before treatment, at weeks 52, 104, and 156 of treatment
COPD part：Forced expiratory volume in the first Second Percentage of predicted value
FEV1% will be applied to assess pulmonary function
Time frame: Before treatment, at weeks 52, 104, and 156 of treatment
COPD part：Maximal Mid-Expiratory Flow
MMEF will be applied to assess pulmonary function
Time frame: Before treatment, at weeks 52, 104, and 156 of treatment
COPD part：Forced expiratory flow at 50% of FVC exhaled
FEF50% will be applied to assess pulmonary function
Time frame: Before treatment, at weeks 52, 104, and 156 of treatment
COPD part：Forced expiratory flow at 75% of FVC exhaled
FEF75% will be applied to assess pulmonary function
Time frame: Before treatment, at weeks 52, 104, and 156 of treatment
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