Abstract
*The corticosteroid budesonide and the long-acting [beta]2-adrenoceptor agonist formoterol have been combined into a single pressurized metered-dose inhaler (pMDI) for use in patients aged > or =12 years with asthma. *In well designed 12-week clinical trials in patients with mild to moderate or moderate to severe persistent asthma, lung function improved to a significantly greater extent with twice-daily budesonide/formoterol pMDI 160 [micro]g/9 [micro]g or 320 [micro]g/9 [micro]g than with placebo or the same nominal dosage of either of the components alone. *Budesonide/formoterol pMDI was also associated with improvements from baseline in patient-reported asthma control, asthma symptom and asthma-related quality of life outcomes that were significantly greater than those with placebo and, for many endpoints, monotherapy with the individual components. *In a 52-week safety study, treatment with twice-daily budesonide/formoterol pMDI 320 [micro]g/9 [micro]g was associated with rapid and durable improvements in lung function and asthma control that were significantly greater than those with twice-daily budesonide pMDI 640 [micro]g monotherapy. *Budesonide/formoterol pMDI was well tolerated in clinical trials. Its overall adverse event profile is consistent with the known tolerability profiles of long-acting [beta]2-adrenoceptor agonist and inhaled corticosteroid therapy, and is similar to that shown with placebo.
Published Version
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