BACKGROUND: The 2018 Global Initiative for Chronic Obstructive Lung Disease publication suggested that the combination of bronchodilator therapy of inhaled glucocorticoid/long-acting β₂ adrenoceptor agonist is more effective in improving pulmonary function and health status in the treatment of patients with acute exacerbations than the individual components; however, it is not known whether this also the case for stable chronic obstructive pulmonary disease (COPD). The purpose of this meta-analysis was to evaluate the effectiveness of budesonide/formoterol in the maintenance and relief therapy of patients with stable COPD.

MATERIAL AND METHODS: An electronic search of the literature in MEDLINE, Embase, and Cochrane Central Register of Controlled Trials was undertaken to identify published randomized controlled trials (RCTs) of ≥12 weeks duration comparing the budesonide/formoterol, with budesonide, formoterol, or placebo in the treatment of patients with stable COPD. The identified RCTs were reviewed. The mean difference (MD) with corresponding 95% confidence interval (CI) was used to pool the results.

RESULTS: Seven high quality studies with RCTs met the inclusion criteria for meta-analysis. Compared with budesonide alone, the combination therapy of budesonide/formoterol showed significant improvement in the following spirometric indices: pre-dose forced expiratory volume in 1 second (FEV₁) (SMD: 0.26, 95% CI: 0.18, 0.34; P=0.000). In addition, versus formoterol alone, budesonide/formoterol was associated with a significant increase in pre-dose FEV₁ (SMD: 0.12, 95% CI: 0.07, 0.17; P=0.000). A similar pattern was also evident in the comparison to placebo, where budesonide/formoterol yielded greater increase in pre-dose FEV₁ (SMD: 0.24, 95% CI: 0.18, 0.30; P=0.000). Moreover, compared with other controls, the combination of budesonide-formoterol significantly improved morning peak expiratory flow and evening peak expiratory flow, significantly reduced the total score of St. George’s Respiratory Questionnaire.

CONCLUSIONS: For stable COPD patients, compared with controls (monocomponents or placebo), budesonide/formoterol improved pulmonary function and health status. Future larger long-term RCTs are warranted to assess the beneficial clinical efficacy of budesonide/formoterol in COPD patients.

Keywords: Budesonide, Pulmonary Disease, Chronic Obstructive, Randomized controlled trial, Budesonide, Formoterol Fumarate Drug Combination, Forced Expiratory Volume, Formoterol Fumarate, Respiratory Function Tests