Abstract
BackgroundSystemic glucocorticoids are effective for the management of chronic obstructive pulmonary disease (COPD) exacerbation but have serious adverse effects. Traditional Chinese medicine (TCM) can bring additional benefits to these patients but has few adverse effects. The present study aims to evaluate the efficacy and safety of Jia Wei Bushen Yiqi (JWBY) formulas in patients who suffer from COPD exacerbations and to investigate whether the short-term (5-days) systemic glucocorticoid therapy is non-inferior to the long-term (9-day) regime.MethodsIn this multi-center, randomized, double-blinded trial, eligible inpatients with COPD exacerbation are randomly assigned to four groups (A, B, C, and D). Group A will receive placebo plus 5-day prednisone, group B will receive placebo plus 9-day prednisone, group C will receive JWBY formulas plus 5-day prednisone, and group D will receive JWBY formulas plus 9-day prednisone. The primary outcomes are the time interval to the patient’s next exacerbation during a 180-day following up and the COPD assessment test (CAT) during treatment. Secondary outcomes include lung function, TCM syndrome assessment, laboratory tests, and safety. The changes of the hypothalamic pituitary adrenaline axis (HPA axis) and inflammatory cytokine will be measured as well.DiscussionBy demonstrating the advantages of utilizing TCM and an appropriate duration of systemic glucocorticoids, this effectiveness comparison trial will provide new references to physicians on how to improve the management of COPD exacerbation. The results of HPA axis and inflammation cytokine measurements will shed light on the molecular mechanisms and entail further mechanism studies.Trial registrationwww.chictr.org.cn ChiCTR1900023364. Registered on 24 May 2019.
Highlights
Background and rationale {6a} Chronic obstructive pulmonary disease (COPD) will become the third leading cause of death worldwide in 2030 [1]. 13.7% of the population over 40 years old suffer from chronic obstructive pulmonary disease (COPD) in China [2], creating a large socioeconomic burden [3,4,5]
A dose of 40 mg prednisone daily for 5 days has been recommended by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Science Committee Report based on the REDUCE randomized clinical trial since 2015 [24]
With the design of Traditional Chinese medicine (TCM) as an adjunct to systemic glucocorticoids to treat COPD exacerbation in this randomized trial, we will test the non-inferiority of two different treatment terms of systemic glucocorticoids in COPD exacerbation
Summary
Background and rationale {6a} Chronic obstructive pulmonary disease (COPD) will become the third leading cause of death worldwide in 2030 [1]. 13.7% of the population over 40 years old suffer from COPD in China [2], creating a large socioeconomic burden [3,4,5]. Acute exacerbations of COPD impair pulmonary function and exponentially increase the risk of death [9]. A dose of 40 mg prednisone (a common oral systemic glucocorticoid) daily for 5 days has been recommended by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Science Committee Report based on the REDUCE randomized clinical trial since 2015 [24]. Systemic glucocorticoids are effective for the management of chronic obstructive pulmonary disease (COPD) exacerbation but have serious adverse effects. The present study aims to evaluate the efficacy and safety of Jia Wei Bushen Yiqi (JWBY) formulas in patients who suffer from COPD exacerbations and to investigate whether the short-term (5-days) systemic glucocorticoid therapy is non-inferior to the long-term (9-day) regime
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