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

NCT06691802 | Not Yet Recruiting DMC

• 1 other identifier: Chronic Airway Diseases
• Study Type: interventional
• Target: 2,312
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (20)

• Asthma part：Asthma Control Test

  at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)

• Asthma part：Asthma Control Questionnaire

  at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)

• Asthma part：Asthma Quality of Life Questionnaire

  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

  at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)

• Asthma part：Disease Control Rate

  at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)

Study Arms (2)

Shu Fei Tie group for Asthma/COPD

EXPERIMENTAL

Patients in the Asthma/COPD experimental group were treated with Shu Fei Tie

Drug: Shu Fei Tie

Shu Fei Tie Placebo group for Asthma/COPD

PLACEBO COMPARATOR

Patients in the Asthma/COPD experimental group were treated with Shu Fei Tie Placebo

Drug: Shu Fei Tie placebo

Interventions

Shu Fei Tie DRUG

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 group for Asthma/COPD

Shu Fei Tie placebo DRUG

Shu Fei Tie Placebos are made using substances without active drug ingredients, following the same preparation procedures

Shu Fei Tie Placebo group for Asthma/COPD

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Henan University of Traditional Chinese Medicine: lead
• Qingdao Municipal Hospital of Traditional Chinese Medicine: collaborator
• Henan Lingrui Pharmaceutical Co., Ltd: collaborator

Study Sites (1)

The First Affiliated Hospital of Henan University of Chinese Medicine

Zhengzhou, Henan, China

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

suyun Li PhD

CONTACT

13938415502; lisuyun2000@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 15, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: November 15, 2024

Record last verified: 2024-11

Locations

CN (1)