Source: Annual Congress 2002 - Asthma - Therapy and management -1
Disease area: Airway diseases

Abstract

The safety of formoterol 4.5 μg (Oxis®) as reliever therapy was compared with salbutamol 200 μg (pMDI or dry powder inhaler) in a multinational, 6-month, open study. Blinding study drug with a placebo double-dummy reliever was excluded on the grounds of safety. Patients were randomized to reliever therapy with formoterol (n=9064) and salbutamol (n=9060) in addition to regular maintenance therapy, inhaled corticosteroids and regular long-acting β₂-agonists (76% and 31% of patients, respectively). The number of adverse events (AEs) and serious adverse events (SAEs) was low in both arms of the study, with no statistically significant differences. Formoterol provided greater clinical benefit on several parameters, and was associated with fewer [dsquote]asthma aggravated[dsquote] reports (p=0.018 versus salbutamol) and asthma exacerbations (p<0.001 versus salbutamol). However, discontinuations related to AEs were marginally higher with formoterol (2.4% versus 1.3%; p<0.001), entirely due to non-serious AEs. Discontinuations for SAEs were 0.4% in both groups. The 1.1% difference in discontinuations versus salbutamol, despite the greater overall level of asthma control on formoterol, probably relates to the likelihood of patients and physicians being more inclined to discontinue a new than an old drug in an open study. We conclude that the safety profile for formoterol as-needed was similar to that of salbutamol.

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Safety of formoterol turbuhaler when used as a reliever therapy in asthma (the RELIEF study). Eur Respir J 2002; 20: Suppl. 38, 393

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