Nebulized Budesonide in the Treatment of Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD): A Randomized, Double Blind, Double Dummy, Parallel Controlled, Multicenter Tria

Abstract

PURPOSE: The objective of this study is to evaluate the effectiveness and safety of nebulized glucocorticoids therapy for AECOPD, with systemic administration of glucocorticoids and placebo as control. METHODS: This was a multi-center, randomized, double blind, double dummy and parallel controlled trial. AECOPD patients were randomly assigned into BUD group (n=53, nebulized budesonide 2mg/4ml, q6h and normal saline (NS) 10ml iv qd or MP group (n=54, methylprednisolone 40mg, iv and nebulized NS 4ml q6h, or placebo group (n=46, nebulized NS 4ml q6h and NS 10ml iv qd) for 7 days. RESULTS: The number of withdraw rate due to treatment failair was significantly higher in placebo group than in BUD and MP groups (p=0.005). The average improvement of FEV1 after 72 hours of treatment in the BUD group and MP group were 140ml (increased 22.9% from baseline) and 190 ml (25.7%), respectively, which were significantly higher than in the placebo group 110ml (15.2%). 7 days after treatment, FEV1 improvement in the BUD group (230ml, 33.3%) was the greatest among the 3 groups. Shortness of breath was significantly alleviated in all of the 3 groups, with better improvement in the BUD group and the MP group than in the placebo group (p<0.05). Use of rescue medication and systemic glucocorticoids, and number of hospitalization days were similar among the 3 groups. The incidence of adverse events of the 3 groups were 11.3%, 8.9% and 10.9%. 10.4% of the patients in the BUD group experienced blood glucose elevation, and 6.5% of the patients in the MP group had the same experience. CONCLUSIONS: Nebulized glucocorticoids and intravenous glucocorticoids were better than placebo in improving pulmonary function and releasing shortness of breath. Though the percentage of adverse events in the 3 groups remained similar, further investigation to the effect of both corticosteriod therapies on blood glucose is necessary. CLINICAL IMPLICATIONS: Nebulized glucocorticoids therapy could be an option for the treatment of AECOPD. It was as effective as sytematic administration of corticosteriods. DISCLOSURE: The following authors have nothing to disclose: Jinping Zheng, Jiangtao Lin, Xin Zhou, Shaoguang Huang, Canmao Xie, Zongan Liang, Kaisheng Yin, Wenbing Xu, Jia He, Nanshan Zhong.