The efficacy of formoterol in patients with chronic obstructive pulmonary disease (COPD) is not influenced by concomitant corticosteroid use
A. P. M. Greefhorst, M. H. Thomson, A. Byrne, D. Till (Hengelo, The Netherlands; Horsham, United Kingdom)
Source: Annual Congress 2001 - Long-acting β2-agonists: clinical effects
Session: Long-acting β2-agonists: clinical effects
Session type: Oral Presentation
Number: 3474
Disease area: Airway diseases
Abstract There are conflicting reports on the effects of concomitant corticosteroids on bronchodilator responses in COPD (Corden & Rees, Respir Med 1998 ;92 :279–82). In a multicentre, randomized, double-blind, double-dummy, placebo-controlled study, 780 patients with COPD were randomized to receive inhalation therapy with either formoterol (Foradil® Aerolizer™) 12 μg (F12) or 24 μg (F24) b.i.d., placebo (P), or ipratropium bromide 40 μg q.i.d. (IB) for 3 months. Patients were subdivided according to concomitant corticosteroid therapy (oral or inhaled vs none). The primary efficacy endpoint was the FEV1 area under the curve (AUC) measured over 12 hours at 3 months; a difference of 120 mL was considered clinically significant. Treatment differences in FEV1 AUC are shown below :
Steroid users (n=405) No steroid use (n=370) Difference (mL) p-value Difference (mL) p-value F24 vs P 221* <0.001 187* <0.001 F12 vs P 216* <0.001 232* <0.001 IB vs P 119 <0.001 155* <0.001 *Clinically significant
In conclusion, in COPD patients, Foradil® delivered by the Aerolizer™ produces statistically and clinically relevant improvements in lung function compared with placebo, which are not influenced by concomitant corticosteroid treatment.
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A. P. M. Greefhorst, M. H. Thomson, A. Byrne, D. Till (Hengelo, The Netherlands; Horsham, United Kingdom). The efficacy of formoterol in patients with chronic obstructive pulmonary disease (COPD) is not influenced by concomitant corticosteroid use. Eur Respir J 2001; 16: Suppl. 31, 3474
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