Clinical Evaluation of Nebulised Budesonide in Acute Exacerbation of Chronic Obstructive Pulmonary Disease– A Randomised Study

Abstract

BACKGROUND Exacerbations in chronic obstructive pulmonary disease is common and frequent in nature. The present study was done to evaluate the clinical efficacy of nebulised budesonide over parenteral/oral steroids in patients with acute exacerbations of COPD. MATERIALS AND METHODSA randomised controlled study was conducted in a tertiary care teaching hospital. A total of 125 patients with acute exacerbations due to COPD were included in the study. The patients were randomised into study and control groups. The study group patients received inhaled budesonide along with the standard treatment for 5 days, while the control group received standard treatment for acute exacerbation of COPD. The primary outcome variables studied for the treatment efficacy were change in post bronchodilator FEV1, FVC, FEV1/FVC, PEFR. Secondary end points included the changes in dyspnoea score (MMRC grade, SPO2 and SGRQ score). RESULTSA total of 125 patients were finally assessed. Sixty five patients belonged to study group and 60 in the control group. Baseline characteristics were similar and well matched in both the groups. Mean age was 64.20 ± 9.11 years while in control group it was 62.40 ± 11.31 years. There were no improvements in the lung functions (FEV1, FVC, FEV1/FVC, PEFR) at the end of 5 days of nebulised budesonide as compared to the standard therapy. As far as secondary outcome is concerned, it was observed that patients in study group showed better improvement in health related quality of life (HRQL) score as compared to control group at day 5 (p<0.01). Duration of hospitalisation also was lesser in the study group as compared to the control group. No serious adverse effects were observed during the course of the study. CONCLUSIONOverall with the nebulised budesonide for the AECOPD, there was not much improvement in the lung functions, but there was improvement in the quality of life and the duration of hospitalisation in the study group. These findings should be confirmed by conducting a larger population based clinical study.