Clinical Study on the Treatment of Chronic Airway Diseases (Asthma, Chronic Obstructive Pulmonary Disease) with Shu Fei Tie
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Shu Fei Tie, Shu Fei Tie placebo.
- Who it may be relevant to
- Registry conditions: Chronic Obstructive Pulmoriary Disease (COPD), Asthma. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Study on Reducing Recurrent Attacks of Chronic Airway Diseases (asthma, Chronic Obstructive Pulmonary Disease) with Shu Fei Tie Based on "winter Disease Being Cared in Summer"
Overview
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.
Detailed description
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.
Interventions
- Drug Shu Fei Tie
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） - Drug Shu Fei Tie placebo
Shu Fei Tie Placebos are made using substances without active drug ingredients, following the same preparation procedures
Primary outcome measures
- Asthma part：Number of acute attacks per year [Time frame: Count once a year for three consecutive years]
- COPD part：The number of acute exacerbations per year [Time frame: Count once a year for three consecutive years]
- COPD part：the interval between successive acute exacerbations [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 [Time frame: Count once a year until the end of the 3-year cycle]
Secondary outcome measures (12)
- Asthma part：Asthma Control Test [Time frame: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)]
- Asthma part：Asthma Control Questionnaire [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 [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 [Time frame: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)]
- Asthma part：Disease Control Rate [Time frame: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)]
- Asthma part：readmission rate [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 [Time frame: Before treatment, at weeks 52, 104, and 156 of treatment]
- Asthma part：Peak expiratory flow [Time frame: Before treatment, at weeks 52, 104, and 156 of treatment]
- Asthma part：Fractional exhaled nitric oxide [Time frame: Before treatment, at weeks 52, 104, and 156 of treatment]
- Asthma part：clinical symptoms and signs questionnaire [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 [Time frame: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)]
- COPD part：mMRC [Time frame: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)]
Eligibility criteria
Inclusion criteria
- Meets the diagnostic criteria for asthma/COPD(Group E in the GOLD classification); ② Age range from18 years to 80 years(asthma) and 40 yesrs to 80 years(COPD);
- The investigators agreed to participate in this clinical study by voluntarily signing an informed consent form.
Exclusion criteria
- Patients with other pulmonary diseases (lung abscess, pulmonary interstitial fibrosis, active pulmonary tuberculosis, bronchiectasis，etc);
- Patients with severe cardiovascular and cerebrovascular diseases (malignant arrhythmia, unstable angina, acute myocardial infarction, heart grade 3 or above, stroke, cerebral hemorrhage, etc.);
- Patients with severe liver diseases (liver cirrhosis, portal hypertension, and caused by esophageal and gastric varices) and severe kidney diseases (dialysis, kidney transplantation, etc.);
- Patients with impaired consciousness or various illnesses who cannot communicate normally; ⑤Pregnant and lactating women; ⑥Patients who are participating in other clinical trials within one month prior to enrollment; ⑦Patients who have received acupuncture or other traditional Chinese medicine external treatments within the past year; ⑧ Patients who are allergic to external patches
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital of Henan University of Chinese Medicine — Zhengzhou
Identifiers
NCT: NCT06691802 · Chronic Airway Diseases