Faster onset of bronchodilation with formoterol than with salmeterol in patients with stable, moderate to severe COPD: results of a randomized, double-blind clinical study.
OBJECTIVE
To compare the onset and magnitude of bronchodilation after dry powder inhalations of formoterol fumarate (Foradil Aerolizer) versus salmeterol xinofoate (Serevent Diskus) with respect to normalized (*) forced expiratory volume in 1 s area under the curve 0 to 1 h after inhalation (FEV1 AUC*0-1 h).


METHODS
A double-blind, double-dummy, multicentre, randomized, placebo controlled, single-dose, five-period crossover study.


METHODS
Five centres in four countries - one centre each in France, Greece and Italy, and two centres in the Netherlands.


METHODS
Forty-seven patients aged 42 to 80 years (mean age 63.5 years) with chronic obstructive pulmonary disease (COPD) stage II and III, and mean baseline FEV1 1.17 L (range 0.56 to 1.77 L).


METHODS
Patients inhaled single doses of formoterol dry powder (12 and 24 mg), single doses of salmeterol (50 and 100 mg) and matching placebo on five separate days.


RESULTS
The estimates of treatment difference in absolute terms (0.086 L) and percentage change from predose baseline (7.8%) for the primary end point, FEV1 AUC*0-1 h, showed that formoterol 12 mg was statistically significantly superior to salmeterol 50 mg (P=0.0044 and P=0.0021, respectively). In addition, both doses of formoterol were statistically superior to placebo for both absolute improvement and percentage change (P=0.0001). The analysis of secondary variables also confirmed the superiority of formoterol over salmeterol.


CONCLUSIONS
Formoterol is associated with a faster onset of bronchodilation than salmeterol in patients with COPD.
Kottakis
John
J
Novartis Horsham Research Centre, Horsham, United Kingdom. ioannis.kottakis@pharma.novartis.com
Cioppa
Giovanni Della
GD
Creemers
Jacques
J
Greefhorst
Louis
L
Lecler
Violette
V
Pistelli
Riccardo
R
Overend
Tim
T
Till
Denise
D
Rapatz
G nter
Gn
Le Gros
Vincent
V
Bouros
Demosthenes
D
Siafakas
Nikolaos
N
D000328:Adult; D000336:Aerosols; D000368:Aged; D000420:Albuterol / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D001993:Bronchodilator Agents / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004983:Ethanolamines / Q000627:therapeutic use*; D005260:Female; D000068759:Formoterol Fumarate; D006801:Humans; D008297:Male; D008875:Middle Aged; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy*; D000068299:Salmeterol Xinafoate; D013997:Time Factors
D000336:Aerosols; D001993:Bronchodilator Agents; D004983:Ethanolamines; D000068299:Salmeterol Xinafoate; D000420:Albuterol; D000068759:Formoterol Fumarate