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

Abstract

The safety of formoterol Turbuhaler® (Oxis®) as reliever therapy was compared with salbutamol as needed in a multinational 6-month open study. The evaluated population on formoterol 4.5 μg (n=8924) and salbutamol 200 μg (n=8938) included: children 6–11 years (n=827, n=834) adolescents 12–17 years (n=783, n=796), adults 18–64 years (n=6422, n=6376) and those over 65 years (n=892, n=932). Inhaled corticosteroids were used by 76% of patients and regular long-acting β₂-agonists by 31%. For this analysis, subjects were stratified by age and by level of maintenance medications as recommended for the levels of severity in the GINA guidelines. There was no increase in any adverse events (AEs) with formoterol compared with salbutamol, in any age group, or related to any maintenance treatment group. There was a trend for fewer AEs when formoterol reliever therapy was used in patients taking regular maintenance formoterol compared with maintenance salmeterol, whereas the greatest number of AEs were seen with salbutamol reliever therapy in patients taking maintenance salmeterol (no statistically significant differences). We concluded that formoterol Turbuhaler® as reliever therapy was as safe as salbutamol in all age groups and all strata of asthma severity, irrespective of maintenance medication requirements.

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Safety of formoterol turbuhaler used as reliever in asthma: relationship with age and baseline treatment including regular long-acting β₂-agonists (the RELIEF study). Eur Respir J 2002; 20: Suppl. 38, 394

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