Background: Chronic Obstructive Pulmonary Disease (COPD) is characterized by a progressive deterioration of lung function, which occurs at its fastest rate in the early stages (GOLD I-II). Preliminary clinical investigation has suggested that Cordyceps militaris capsules can improve post-bronchodilator forced expiratory volume in 1 s (FEV1) in mild-to-moderate COPD. However, previous studies were limited by the absence of placebo control. Therefore, this trial is designed to evaluate the efficacy and safety of Cordyceps militaris capsules versus placebo in improving post-bronchodilator FEV1 in patients with mild-to-moderate stable COPD. Methods: This study is a multi-center, randomized, double-blind, placebo-controlled clinical trial involving 160 eligible patients aged between 40 and 85 years. After a 1-week run-in period, participants are randomized in a 1:1 ratio to receive either Cordyceps militaris capsules or placebo capsules for 24 weeks, and are followed for an additional 24 weeks. The primary outcome measure is the change in post-bronchodilator FEV1. Secondary outcome measures comprise additional lung function parameters, such as pre-bronchodilator FEV1, pre- and post-bronchodilator measures of forced vital capacity (FVC), FEV1/FVC ratio, mid-expiratory flow (MMEF), forced expiratory flow 75% (FEF75), forced expiratory flow 50% (FEF50). In addition, frequency of acute exacerbations, time to the first acute exacerbation, COPD Assessment Test (CAT), Cough and Sputum Assessment Questionnaire (CASA-Q), EuroQol five-dimension five-level questionnaire (EQ-5D-5L), and Modified Medical Research Council dyspnea scale (mMRC) are also included. Discussion: This study is designed to evaluate the therapeutic potential of Cordyceps militaris capsules and to provide a traditional Chinese medicine intervention for preserving lung function in mild-to-moderate stable COPD.
[1]Guangzhou Univ Chinese Med, Affiliated Hosp 2, Guangdong Prov Hosp Chinese Med, State Key Lab Tradit Chinese Med Syndrome, Guangzhou 510405, Peoples R China.
[2]Guangdong Prov Key Lab Tradit Chinese Med Prevent, Guangdong Hong Kong Macau Joint Lab Chinese Med &, Hong Kong, Guangdong, Peoples R China.
[3]China Japan Friendship Hosp, Beijing, Peoples R China.
[4]Southern Med Univ, Nanfang Hosp, Guangzhou, Peoples R China.
[5]First Affiliated Hosp Guangzhou Univ Chinese Med, Guangzhou, Peoples R China.
[6]Jiangxi Univ Chinese Med, Nanchang, Peoples R China.
[7]Second Peoples Hosp Baiyun Guangzhou, Guangzhou 510450, Guangdong, Peoples R China.
(8.0+极速模式)