Onset and duration of action of formoterol and tiotropium in patients with moderate to severe COPD.
BACKGROUND
Chronic obstructive pulmonary disease (COPD) management guidelines recommend regular treatment with one or more long-acting bronchodilators for patients with moderate to severe COPD.


OBJECTIVE
To compare the onset and duration of action of formoterol and tiotropium in patients with COPD.


METHODS
This randomized, multicentre, open-label crossover study in 38 patients with COPD (mean age 64 years; mean FEV(1) 55% predicted) assessed the effect of 7 days of treatment with formoterol (12 microg b.i.d. via Foradil Aerolizer) vs. tiotropium (18 microg o.d. via Spiriva HandiHaler) on lung function measured over a period of 12 h after the first dose on day 1 and the last dose on day 8.


RESULTS
The primary efficacy variable, FEV(1)-AUC during the first 2 h post-dose (FEV(1)-AUC(10-120 min)), was significantly higher for formoterol compared with tiotropium, with between-treatment differences of 124 ml (p = 0.016) after the first dose and 80 ml (p = 0.036) after 7 days' treatment in favour of formoterol. FEV(1) measured 12 h after inhalation did not differ statistically significantly between treatments. Adverse events occurred in 2 (5%) patients after treatment with formoterol and in 5 (12%) patients after treatment with tiotropium.


CONCLUSIONS
This study demonstrates faster onset of action and greater bronchodilation of formoterol vs. tiotropium for bronchodilation within the first 2 h of inhalation (FEV(1)-AUC(10-120 min)) and comparable bronchodilation 12 h post-inhalation in patients with moderate to severe COPD.
Richter
Kai
K
Pulmonary Research Institute, Grosshansdorf, Germany. k.richter@pulmoresearch.de
Stenglein
Stephan
S
Mücke
Marion
M
Sieder
Christian
C
Schmidtmann
Sören
S
Harnest
Ulf
U
Weidinger
Gottfried
G
Magnussen
Helgo
H
D000368:Aged; D001993:Bronchodilator Agents / Q000627:therapeutic use*; D004983:Ethanolamines / Q000627:therapeutic use*; D005260:Female; D005541:Forced Expiratory Volume; D000068759:Formoterol Fumarate; D006801:Humans; D008297:Male; D008875:Middle Aged; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000503:physiopathology; D012449:Safety; D012602:Scopolamine Derivatives / Q000627:therapeutic use*; D012907:Smoking / Q000453:epidemiology; D000069447:Tiotropium Bromide; D016896:Treatment Outcome
D001993:Bronchodilator Agents; D004983:Ethanolamines; D012602:Scopolamine Derivatives; D000068759:Formoterol Fumarate; D000069447:Tiotropium Bromide