Efficacy and safety of Xuebijing injection and its influence on immunomodulation in acute exacerbations of chronic obstructive pulmonary disease: study protocol for a randomized controlled trial.

BACKGROUND: Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is the leading cause of mortality in chronic obstructive pulmonary disease (COPD). Traditional Chinese medicine (TCM) has been widely used in Asia as an adjunct treatment for AECOPD to improve the patients' symptoms. Xuebijing (XBJ) injection is one of the major herbal medicines used in TCM. Previous small-sample clinical trials have proven its efficacy and safety in the treatment of AECOPD; however, the current data on XBJ as an adjunct therapy are insufficient. The present study will be a multi-center randomized clinical trial (RCT) to evaluate the efficacy and safety of XBJ injection in AECOPD and explore its influence on the immune function based on the altered levels of T cells.

METHODS: This study will be a prospective, randomized, placebo-controlled, blinded, multi-center trial. A total of 300 eligible patients will be randomly assigned to the treatment or placebo control group in a 1:1 ratio using a central randomization system. The treatment group will receive routine medication plus XBJ injection, and the control group will receive routine medication plus 0.9% NaCl injection. The patients will receive the corresponding treatment for 5 days starting within 24 h of enrollment. The primary outcome, the of rate endotracheal intubation, will be evaluated on day 28 after treatment. The secondary outcomes will include changes in immune and inflammatory indicators, respiratory support, mortality rate after 28 days, blood gas analysis, improvement in Acute physiology and chronic health evaluation (APACHE) II scores and clinical symptoms, and the length and cost of intensive care unit stay and hospitalization. The safety of the interventions will be assessed throughout the trial.

DISCUSSION: This is the first and largest randomized, controlled, blinded trial that evaluates the efficacy of XBJ injection as adjuvant therapy for AECOPD. The results of this trial will provide valuable clinical evidence for recommendations on the management of the disease and identify the underlying mechanisms.

TRIAL REGISTRATION: ClinicalTrials.gov, NCT02937974 . Registered on 13 October 2016. Chinese clinical trial registry, ChiCTR-IPR-17011667. Registered on 15 June 2017.