Efficacy of formoterol 12μg dry powder capsules in 6,155 asthmatic patients poorly controlled with salmeterol or on-demand salbutamol (EFORA study)

C. Brambilla, V. Le Gros, I. Bourdeix (Grenoble, France)

Source: Annual Congress 2002 - Asthma and COPD: pharmacology
Session: Asthma and COPD: pharmacology
Session type: Thematic Poster Session
Number: 736
Disease area: Airway diseases

Congress or journal article abstract

Abstract

The efficacy of a 1-month treatment with formoterol (Foradil® Aerolizer™, 12μg b.i.d.) (F) was assessed in asthmatic adults using >=2 puffs/day rescue salbutamol in spite of an inhaled corticosteroid plus either salmeterol 50μg b.i.d.(S) or on-demand salbutamol (PRN). The study was multicentre, open, comparative parallel group and randomized (1/3 no change, 2/3 to receive formoterol). 6,155 patients were assessed (mean age 49.8 years, 51% male): 3,167 patients previously treated with S (1,340 treated with S in Diskus™, 1,827 switched to F), 2,988 previously with PRN (674 treated with PRN, 2,314 switched to F). Results:

PEF (l/min) No symptoms No rescue salbutamol
Evening Morning % days % nights % days % nights
S [arrowright]S 385.5 383.4 50.0 56.1 53.0 60.9
[arrowright]F 402.9* 398.2* 60.4* 67.2* 65.3* 74.6*
PRN [arrowright]PRN 385.0 381.9 42.2 46.6 38.0 51.4
[arrowright]F 409.3* 405.5* 64.9* 70.7* 66.9* 76.3*
(mean values, *p<0.001 vs. S or PRN).


Respectively 75% and 82% of the patients previously treated with S or PRN and switched to F, preferred F. In total, 91% of the patients found the Aerolizer™ inhalation device easy or very easy to use, and 85% considered the visual dose confirmation an advantage. All treatments were well tolerated. In conclusion, this study shows that F significantly improves asthma in patients poorly controlled with either PRN or with S.


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C. Brambilla, V. Le Gros, I. Bourdeix (Grenoble, France). Efficacy of formoterol 12μg dry powder capsules in 6,155 asthmatic patients poorly controlled with salmeterol or on-demand salbutamol (EFORA study). Eur Respir J 2002; 20: Suppl. 38, 736

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