Optimization of Nebulized Budesonide in the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Abstract

Background

Clinical studies have suggested nebulized budesonide (NB) as an alternative to systemic corticosteroids for patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD). However, the optimal budesonide dose for AECOPD remains unclear.

Objectives

To compare the efficacy and safety of different doses of NB in the management of AECOPD.

Patients and Methods

A total of 321 AECOPD patients with moderate-to-severe exacerbation were randomly divided into three groups and treated with NB. The low dose group (L) was given 4 mg/day (n=95, 1 mg Q6h), while high-dose group 1 (H1, n=111, 2 mg Q6h) and high-dose group 2 (H2, n=115, 4 mg Q12h) were given 8 mg/day. Patients also received routine treatment including oxygen therapy, expectorant, nebulization bronchodilators, antibiotics, and fluid rehydration. The COPD assessment test (CAT), lung function, and artery blood gas were evaluated before and after 3 hrs and 5 days of treatment. In addition, hospital stay, frequency of acute exacerbations within 3 months of discharge, and adverse events during treatment were compared.

Results

H1 and H2 showed improved spirograms and CAT score faster than L. In H2, forced expiratory volume in 1 s (FEV₁%) at 3 hrs and FEV₁%, forced expiratory flow after 50% of the forced vital capacity has been exhaled (FEF_50%), mean forced expiratory flow between 25% and 75% of forced vital capacity (FEF_25–75%) and CAT score at 5 days were significantly improved compared to L. FEV₁% improved most in H2, moderately in H1, and least in L, with significant differences between groups at 5 days. No differences between groups were observed in adverse effects, hospital stay, and frequency of exacerbations within 3 months of discharge.

Conclusion

Compared to the conventional dose (4 mg/day), a high dose (8 mg/day) of NB improved pulmonary function and symptoms more effectively in the early treatment of AECOPD, especially when given as 4 mg twice daily.

Keywords:

• obstructive pulmonary disease
• exacerbation
• nebulized budesonide
• dose
• pulmonary function

Acknowledgments

This study was supported in part by grants from the National Natural Science Foundation of China (Grant No. 81600044), the Six Talent Peaks Project in Jiangsu Province, China (Grant No. WSN-081), and the Xuzhou City Bureau of Science and Technology Project (Grant No. KC KC18058). Written informed consent was obtained from patients for publication of this manuscript and any accompanying images.

Disclosure

The authors have no conflicts of interest to declare.