Efficacy and Safety of Modified Bushen Yiqi Formulas(MBYF) as Add-On To Formoterol and Budesonide in The Management of COPD: Study Protocol for A Multi-Center, Double-Blinded, Placebo-Controlled, Parallel-Group, Randomized Clinical Trial

Introduction Inhaled glucocorticoid Corticosteroids(ICS), long-acting β2-adrenoceptor agonists(LABA)and other drugs have limited therapeutic effects on COPD with significant individual differences. Traditional Chinese Medicine (TCM) modified Bushen Yiqi formulas༈MBYF༉demonstrates advantages in COPD management in China. This study aims to confirm the related genes affecting the therapeutic effect in the treatment of COPD and evaluate the efficacy and safety of MBYF as an add-on to budesonide/ formoterol on COPD patients. Methods and analysis In this multicenter, randomized, double-blinded, placebo-controlled, parallel-group study, eligible patients with COPD will randomly receive 360-day placebo or MBYF as an add-on to budesonide/ formoterol in 1:1 ratio, and followed-up bimonthly. The primary outcomes are frequency, times and severity of acute exacerbation of COPD (AECOPD), COPD assessment test (CAT) score, pulmonary function tests(PFTs). The secondary outcomes include the modified medical research council (mMRC) dyspnea scale、six minutes walking test (6MWT)、BODE index、quantitative scores of TCM syndrome、inflammation indexes and hypothalamic pituitary adrenaline (HPA) axis function. We also test the genotype to find the relationship between drugs and efficacy. All the data will be recorded in case report forms(CRFs) and analyzed by SPSS V.20.0. Trial registration number ChiCTR1900026124, Prospective registration. Protocol version 2019-09-15