A randomized, 12-week, double-blind, placebo-controlled study comparing formoterol dry powder inhaler with albuterol metered-dose inhaler

Citation
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
Citations number
24
Categorie Soggetti
Clinical Immunolgy & Infectious Disease
Journal title
ANNALS OF ALLERGY ASTHMA & IMMUNOLOGY
ISSN journal
10811206 → ACNP
Volume
86
Issue
1
Year of publication
2001
Pages
19 - 27
Database
ISI
SICI code
1081-1206(200101)86:1<19:AR1DPS>2.0.ZU;2-H
Abstract
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.