Source: Annual Congress 2001 - Long-acting β2-agonists: clinical effects
Disease area: Airway diseases

Abstract

A multicentre, randomized, double-blind, placebo-controlled study compared the efficacy of formoterol delivered via dry powder inhaler (Foradil® Aerolizer™) and oral slow release theophylline (Theo-dur®) in 854 patients with COPD. Patients were randomized to receive b.i.d. inhaled formoterol 12 μg (F12), formoterol 24 μg (F24) or placebo (P) (double-blind arms), or b.i.d. oral slow-release theophylline at individual doses based on serum levels (T) (open arm). Patients were subdivided according to concomitant corticosteroid therapy (oral or inhaled). 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=348)		No steroid use (n=377)
	Difference (mL)	p-value	Difference (mL)	p-value
F12 vs P	212*	<0.001	194*	<0.001
F24 vs P	213*	<0.001	202*	<0.001
T vs P	168*	<0.001	46	NS
*Clinically significant; NS=not significant

In conclusion, unlike theophylline, which elicited a bronchodilator response only in patients receiving concomitant corticosteroids, Foradil® delivered by the Aerolizer™ significantly improved lung function compared with placebo in COPD patients regardless of concomitant steroid therapy.

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P. Kristufek, B. Levine, G. Della Cioppa, A. Byrne, D. Till (Bratislava, Slovakia; Phoenix, United States Of America; Horsham, United Kingdom). Bronchodilatory effects of formoterol in patients with chronic obstructive pulmonary disease (COPD) are not influenced by concomitant corticosteroid use. Eur Respir J 2001; 16: Suppl. 31, 3473

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