Effect of sequential treatment with syndrome differentiation on acute exacerbation of chronic obstructive pulmonary disease and "AECOPD Risk-Window": study protocol for a randomized placebo-controlled trial

A prospective, multi-center, single-blinded, double-dummy and randomized controlled clinical trial is being conducted to test the therapeutic effects of a sequential two stage treatment, which includes eliminating pathogen and strengthening vital qi with syndrome differentiation. A total of 364 patients will be enrolled in this study with 182 in each treatment group (TCM and control). Patients received medication (or control) according to their assigned group. TCM for AECOPD were administered twice daily to patients with AECOPD over 7 to 21 days, followed by TCM for AECOPD-RW over 28 days. All patients were followed for six months. The clinical symptoms, the modified medical research council dyspnea (MMRC) scale and exacerbations were used as the primary outcome measures. Pulmonary function, quality of life and mortality rate were used as secondary outcome measures.It is hypothesized that sequentially eliminating pathogens and strengthening vital qi treatments with syndrome differentiation will have beneficial effects on reducing the frequency and duration of acute exacerbation, relieving symptoms and improving quality of life for COPD patients.This study is registered at ClinicalTrials.gov, ChiCTR-TRC-11001460.Chronic obstructive pulmonary disease (COPD) is characterized by acceleration in the normal decline in lung function with age and by repeated exacerbations. These exacerbations are associated with worsening symptoms and lung function [1]. The frequency of exacerbation has been shown to be an important determinant of the impaired health-related quality of life seen in COPD patients [2] and to affect decline in lung function [3]. Exacerbations are a frequent cause of physician consultation in primary and secondary care and a major cause of hospital admission and death [4]. Therefore, the management of exacerbations places a considerable burden on the health services both in terms of physician consultation time and healthcare cost [5]. A reduction in exacerbatio