Clinical trial NCT06691802: Clinical Study on the Treatment of Chronic Airway Diseases (Asthma, Chronic Obstructive Pulmonary Disease) with Shu Fei Tie
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"
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmoriary Disease (COPD)
Asthma
Keywords: Chronic Obstructive Pulmoriary Disease
Asthma
Shu Fei Tie
Winter disease being cared in summer
Randomized Controlled Trial
Lead sponsor: Henan University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Qingdao Municipal Hospital of Traditional Chinese Medicine
name: Henan Lingrui Pharmaceutical Co., Ltd
First posted: 2024-11-15
Enrollment: 2312
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Asthma part：Number of acute attacks per year
timeFrame: Count once a year for three consecutive years
measure: COPD part：The number of acute exacerbations per year
timeFrame: Count once a year for three consecutive years
measure: COPD part：the interval between successive acute exacerbations
timeFrame: at weeks 13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)，Until the first acute exacerbation occurs
measure: COPD part:the number of rehospitalizations within a year
timeFrame: Count once a year until the end of the 3-year cycle
Secondary outcomes:
measure: Asthma part：Asthma Control Test
timeFrame: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)
measure: Asthma part：Asthma Control Questionnaire
timeFrame: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)
measure: Asthma part：Asthma Quality of Life Questionnaire
timeFrame: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)
measure: Asthma part：Frequency of anti-inflammatory and analgesic use
timeFrame: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)
measure: Asthma part：Disease Control Rate
timeFrame: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)
measure: Asthma part：readmission rate
timeFrame: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)
measure: Asthma part：Forced expiratory volume in the first second
timeFrame: Before treatment, at weeks 52, 104, and 156 of treatment
measure: Asthma part：Peak expiratory flow
timeFrame: Before treatment, at weeks 52, 104, and 156 of treatment
measure: Asthma part：Fractional exhaled nitric oxide
timeFrame: Before treatment, at weeks 52, 104, and 156 of treatment
measure: Asthma part：clinical symptoms and signs questionnaire
timeFrame: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)
measure: COPD part：clinical symptoms and signs questionnaire
timeFrame: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)
measure: COPD part：mMRC
timeFrame: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)
measure: COPD part：CAT
timeFrame: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)
measure: COPD part：SGRQ
timeFrame: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)
measure: COPD part：Forced expiratory volume in the first second
timeFrame: Before treatment, at weeks 52, 104, and 156 of treatment
measure: COPD part：Forced Vital Capacity
timeFrame: Before treatment, at weeks 52, 104, and 156 of treatment
measure: COPD part：Forced expiratory volume in the first Second Percentage of predicted value
timeFrame: Before treatment, at weeks 52, 104, and 156 of treatment
measure: COPD part：Maximal Mid-Expiratory Flow
timeFrame: Before treatment, at weeks 52, 104, and 156 of treatment
measure: COPD part：Forced expiratory flow at 50% of FVC exhaled
timeFrame: Before treatment, at weeks 52, 104, and 156 of treatment
measure: COPD part：Forced expiratory flow at 75% of FVC exhaled
timeFrame: Before treatment, at weeks 52, 104, and 156 of treatment
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Henan University of Chinese Medicine
state: Henan
Study officials:
References: