Budesonide and formoterol in a single pressurized metered-dose inhaler for treatment of COPD

Budesonide/formoterol in two dosage strengths (80/4.5 µg and 160/4.5 µg), each administered as two inhalations twice daily, was previously developed as a fixed-dose inhaled corticosteroid/long-acting β-agonist combination in a pressurized metered-dose inhaler for use in asthma. More recent double-blind, randomized controlled trials of 6 and 12 months duration (referred to, respectively, as SHINE and SUN) have demonstrated the efficacy and safety of the higher-dose formulation in patients with severe and very severe chronic obstructive pulmonary disease. Specifically, budesonide/formoterol 160/4.5 µg (two inhalations twice daily) has demonstrated additive benefits over one or the other of its monocomponents with respect to improvements in morning predose and 1-h postdose lung function, as well as greater improvements in respiratory symptoms, health status and rescue medication use, and greater reductions in exacerbations of chronic obstructive pulmonary disease than placebo. It also has a satisfactory safety profile and has not been shown to increase the risk of pneumonia.