Therapeutic comparison of a new budesonide/formoterol pMDI with budesonide pMDI and budesonide/formoterol DPI in asthma

Summary Background:  Budesonide/formoterol is an effective treatment for both asthma and chronic obstructive pulmonary disease. This study compared the efficacy and safety of a novel hydrofluoroalkane (HFA) pressurised metered‐dose inhaler (pMDI) formulation of budesonide/formoterol with that of budesonide pMDI and budesonide/formoterol dry‐powder inhaler (DPI; Turbuhaler ® ). Methods:  This was a 12‐week, multinational, randomised, double‐blind, double‐dummy study involving patients aged ≥ 12 years with asthma. All patients had a forced expiratory volume in 1 s of 50–90% predicted normal and were inadequately controlled on inhaled corticosteroids (500–1600  μ g/day) alone. Following a 2‐week run‐in, during which they received their usual medication, patients were randomised (two inhalations twice daily) to budesonide pMDI 200  μ g, budesonide/formoterol DPI 160/4.5  μ g or budesonide/formoterol pMDI 160/4.5  μ g. The primary efficacy end‐point was change from baseline in morning peak expiratory flow (PEF). Results:  In total, 680 patients were randomised, of whom 668 were included in the primary analysis. Therapeutically equivalent increases in morning PEF were observed with budesonide/formoterol pMDI (29.3 l/min) and budesonide/formoterol DPI (32.0 l/min) (95% confidence interval: −10.4 to 4.9; p = 0.48). The increase in morning PEF with budesonide/formoterol pMDI was significantly higher than with budesonide pMDI (+28.7 l/min; p < 0.001). Similar improvements with budesonide/formoterol pMDI vs. budesonide pMDI were seen for all secondary efficacy end‐points. Both combination treatments were similarly well tolerated. Conclusions:  Budesonide/formoterol, administered via the HFA pMDI or DPI, is an effective and well‐tolerated treatment for adult and adolescent patients with asthma, with both devices being therapeutically equivalent.