Formoterol (Foradil ®) and medium-high doses of inhaled corticosteroids are more effective than high doses of corticosteroids in moderate-to-severe asthma

This double-blind, randomised, multi-centre, parallel-group study compared the effect of adding Foradil ® (formoterol fumarate) to existing medium-high doses of inhaled corticosteroids (ICS) with that of doubling the dose of ICS in patients with sub-optimally controlled asthma. After a run-in period, 203 patients with moderate-to-severe asthma who remained symptomatic despite treatment with 500 μg beclomethasone twice daily, were randomised to receive either 12 μg formoterol twice daily (Foradil ® Aerolizer ®, Novartis) in addition to beclomethasone 500 μg twice daily, or beclomethasone 1000 μg twice daily and placebo for 12 weeks. The primary efficacy variable was mean morning pre-medication peak expiratory flow (PEF) during the last seven days of treatment. The difference in PEF between treatments was 27.78 l/min in favour of the formoterol/beclomethasone combination (95% CI 13.42, 42.14 l/min, p=0.0002, intention-to-treat population). Significant differences in the urinary cortisol/creatinine ratio between treatment groups at 12 weeks ( p=0.001) indicated suppression of the hypothalamic-pituitary-adrenal axis in the patients on beclomethasone 1000 μg twice daily. The addition of formoterol 12 μg twice daily to beclomethasone in patients with asthma who were poorly controlled with beclomethasone 500 μg twice daily was more effective than doubling the ICS dose and resulted in less suppression of the hypothalamic-pituitary-adrenal axis.