Budesonide/formoterol pressurized metered-dose inhaler: in chronic obstructive pulmonary disease.

The corticosteroid budesonide and the rapid-onset, long-acting beta(2)-adrenoceptor agonist formoterol have been combined into a single pressurized metered-dose inhaler (pMDI) for use in patients with chronic obstructive pulmonary disease (COPD). Well designed 6- and 12-month clinical trials, twice-daily budesonide/formoterol pMDI 320 microg/9 microg effectively improved lung function in patients with moderate to very severe COPD. The co-primary endpoints of adjusted mean morning predose forced expiratory volume in 1 second (FEV(1)) and 1-hour post-dose FEV(1) improved from baseline to a significantly greater extent with twice-daily budesonide/formoterol pMDI 320 microg/9 microg than with twice-daily placebo, budesonide pMDI 320 microg and formoterol dry powder inhaler 9 microg. Budesonide/formoterol pMDI was also associated with improvements from baseline in other measures of lung function, COPD control (including the time to first COPD exacerbation in the 12-month trial), symptoms and health status. These improvements were significantly greater than those observed with placebo and, for some endpoints, monotherapy with the individual components. Budesonide/formoterol pMDI was well tolerated in clinical trials in patients with COPD. Its overall adverse event profile is consistent with the known tolerability profiles of formoterol and budesonide, and is generally similar to that with placebo.

RCT Entities:   Population Interventions Outcomes