G. Bensch et al., A randomized, 12-week, double-blind, placebo-controlled study comparing formoterol dry powder inhaler with albuterol metered-dose inhaler, ANN ALLER A, 86(1), 2001, pp. 19-27
Background: Formoterol is a beta (2)-adrenergic agent which, when inhaled,
produces rapid and long-lasting bronchodilatation.
Objective: The aim of this study was to compare the efficacy, safety, and t
olerability of formoterol powder for inhalation delivered via the Aerolizer
device with placebo and with albuterol delivered via metered-dose inhaler
in patients with mild to moderate persistent asthma.
Methods: In a multicenter, double-blind, parallel-group study, 541 patients
were randomized at 26 trial sites to receive either formoterol, 12 mug twi
ce daily; formoterol, 24 mug twice daily; albuterol, 180 mug four times dai
ly; or a placebo for 12 weeks. The effects of each treatment on lung functi
on, asthma symptoms, and frequency of rescue albuterol use were evaluated.
Adverse effects and clinical laboratory parameters were also evaluated.
Results: The bronchodilatory effects of formoterol were rapid in onset and
persisted for 12 hours. Both formoterol doses were more effective than plac
ebo and albuterol for objective measures of lung function. Morning and even
ing peak expiratory flow rates were more improved with formoterol, and form
oterol provided significantly greater improvements in asthma symptom scores
compared with both albuterol and placebo. Overall, patients taking formote
rol used significantly less rescue medication than did those taking albuter
ol or placebo. Nocturnal awakenings occurred less often with formoterol tha
n with placebo or albuterol. The therapeutic effects of formoterol were mai
ntained over the entire 12 weeks of treatment. Adverse events were similar
for all treatment groups, and clinical laboratory data were unremarkable.
Conclusions: Rapid-onset, long-acting formoterol, administered via the Aero
lizer inhaler, is an effective and safe treatment for patients with mild to
moderate persistent asthma.