Clinical Study on the Treatment of Chronic Airway Diseases (Asthma, Chronic Obstructive Pulmonary Disease) with Shu Fei Tie

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"

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Asthma; Chronic Obstructive Pulmoriary Disease (COPD)
• Intervention / Treatment: Drug: Shu Fei Tie; Drug: Shu Fei Tie placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 2312
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Suyun Li PhD; Phone Number: 13938415502; Email: lisuyun2000@126.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China
      • the First Affiliated Hospital of Henan University of Chinese Medicine
      • Contact: Suyun Li PhD; Phone Number: 13938415502; Email: lisuyun2000@126.com

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shu Fei Tie group for Asthma/COPD; Patients in the Asthma/COPD experimental group were treated with Shu Fei Tie	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）
Placebo Comparator: Shu Fei Tie Placebo group for Asthma/COPD; Patients in the Asthma/COPD experimental group were treated with Shu Fei Tie Placebo	Drug: Shu Fei Tie placebo; Shu Fei Tie Placebos are made using substances without active drug ingredients, following the same preparation procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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.	Count once a year until the end of the 3-year cycle

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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	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.	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.	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	Before treatment, at weeks 52, 104, and 156 of treatment
Asthma part：Peak expiratory flow	PEF will be applied to assess pulmonary function	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	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.	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.	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.	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.	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.	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	Before treatment, at weeks 52, 104, and 156 of treatment
COPD part：Forced Vital Capacity	FVC will be applied to assess pulmonary function	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	Before treatment, at weeks 52, 104, and 156 of treatment
COPD part：Maximal Mid-Expiratory Flow	MMEF will be applied to assess pulmonary function	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	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	Before treatment, at weeks 52, 104, and 156 of treatment

Collaborators and Investigators

• Sponsor: Henan University of Traditional Chinese Medicine
• Collaborators: Qingdao Municipal Hospital of Traditional Chinese Medicine; Henan Lingrui Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: November 11, 2024
• First Submitted That Met QC Criteria: November 14, 2024
• First Posted (Actual): November 15, 2024

Study Record Updates

• Last Update Posted (Actual): November 15, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Asthma; Randomized Controlled Trial; Chronic Obstructive Pulmoriary Disease; Shu Fei Tie; Winter disease being cared in summer
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Asthma
• Other Study ID Numbers: Chronic Airway Diseases

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No