Patients with moderate-to-very-severe chronic obstructive pulmonary disease (COPD) had decreased exacerbations after 3 months of commencing budesonide/formoterol treatment, according to a study published in the International Journal of COPD.

Peter M Calverley, MD, from the Department of Clinical Sciences at the Institute of Aging and Chronic Disease, University Hospital Aintree, in Liverpool, UK, and colleagues conducted a post hoc analysis of 3-month data from 3 studies of patients with moderate-to-very-severe COPD.

A total of 1,571 patients were treated twice daily with budesonide/formoterol 320/9 µg or placebo. In one study, the patients also received titropium 18 µg once daily. The researchers examined the 3-month post-randomization outcomes, including exacerbation rates, dropouts, symptoms, reliever use, and lung function.

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Fewer patients in the budesonide/formoterol group experienced exacerbations compared with the placebo group (111 vs 196 patients with ≥1 exacerbation), and the results were consistent in each COPD severity group. The budesonide/formoterol treatment led to lower 3-month exacerbation rates in the moderate and severe COPD severity groups (46% and 57% reduction, respectively). The very severe COPD severity group experienced a 29% nonsignificant reduction.

In addition, the researchers observed fewer dropouts among participants taking budesonide/formoterol compared with the placebo group. Budesonide/formoterol was also associated with improved forced expiratory volume in 1 second, morning peak expiratory flow rate, total reliever use, and total symptom score.

“Whether these changes in objective patient-reported outcomes can be used to predict a further course of events remains to be established at an individual patient level,” the study authors wrote. “However, they should reassure clinicians that treatment is effective across a range of endpoints, including exacerbation prevention, soon after initiation.”


  1. Calverley PM, Eriksson G, Jenkins CR, et al. Early efficacy of budesonide/formoterol in patients with moderate-to-very-severe COPD. Int J COPD. 2016. doi:10.2147/COPD.S114209