01.09.2008 | Adis Drug Profile
Budesonide/Formoterol Pressurized Metered-Dose Inhaler
Erschienen in: Drugs | Ausgabe 13/2008
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▲ The corticosteroid budesonide and the long-acting β2-adrenoceptor agonist formoterol have been combined into a single pressurized metered-dose inhaler (pMDI) for use in patients aged ≥12 years with asthma.
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▲ 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 µg/9 µg or 320 µg/9 µg than with placebo or the same nominal dosage of either of the components alone.
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▲ 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.
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▲ In a 52-week safety study, treatment with twice-daily budesonide/formoterol pMDI 320 µg/9 µg 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 µg monotherapy.
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▲ Budesonide/formoterol pMDI was well tolerated in clinical trials. Its overall adverse event profile is consistent with the known tolerability profiles of long-acting β2-adrenoceptor agonist and inhaled corticosteroid therapy, and is similar to that shown with placebo.