JMIR Publications

ABSTRACT

Background:

Bronchial asthma (asthma) and chronic obstructive pulmonary disease (COPD) are the most prevalent chronic airway disorders (CAD). Their recurrent exacerbations constitute the primary drivers of impaired quality of life and substantial economic burden in affected patients. Acupoint application, a commonly used technique in traditional Chinese medicine (TCM), has been widely employed in the prevention and treatment of CAD. Shu Fei Tie (SFT) is a novel TCM-based acupoint patch that has been shown to reduce the frequency of acute exacerbations in CAD patients. However, its therapeutic efficacy in CAD requires further validation, largely because of the limited availability of high-quality clinical studies with large sample sizes, rigorous controls, and long-term follow-up. This study aims to systematically evaluate the clinical efficacy and safety of SFT in COPD and asthma management.

Objective:

This study aims to observe the clinical efficacy and safety of SFT in reducing acute exacerbations of COPD and asthma.

Methods:

This multicenter, randomized, double-blind, placebo-controlled trial will enroll 980 patients with stable COPD and 1332 patients with asthma in remission. Participants will be assigned via central randomization to receive either SFT (treatment group) or a placebo (control group). Interventions will begin 10 days before Chufu (the first phase of the lunar hot season) each year, with applications administered once every 10 days (6–8 hours per session), for a total of five sessions annually over a three-year treatment course. Primary endpoints are defined as the annual frequency of acute attacks in asthma and the annual rate of acute exacerbations in COPD. Secondary outcomes in asthma include the Asthma Control Test (ACT), Asthma Control Questionnaire (ACQ), Asthma Quality of Life Questionnaire (AQLQ), as well as other relevant indicators; secondary outcomes in COPD comprise clinical symptom scores, pulmonary function parameters, and other relevant indicators. These outcomes will be assessed at baseline, post-treatment, and every 13 weeks during follow-up. Pulmonary function and safety parameters will be evaluated before and after each annual treatment course.

Results:

Recruitment began on July 1, 2025. All participants have been recruited. Data analysis will be complete by the end of August 2028, with study findings available by December 2028.

Conclusions:

The results of this study are expected to provide high-quality evidence on the efficacy and safety of SFT in the treatment of COPD and asthma, contributing to improved methodology and reporting standards in the field. Clinical Trial: Clinical Trials.gov NCT06691802; Registered on 15 November 2024. https://clinicaltrials.gov/study/NCT06691802.