A 6-month comparison between formoterol and salmeterol in patients with reversible obstructive airways disease

• Published in: Respiratory medicine 1998-06, Vol.92 (6), p.836-842
• Main Authors: Vervloet, D., Ekström, T., Pela, R., Gracia, F.Duce, Kopp, C., Silvert, B.D., Quebe-Fehling, E., Cioppa, G.Della, Di Benedetto, G.
• Format: Article
• Language: English
• Subjects: Administration, Inhalation; Adolescent; Adrenergic beta-Agonists - administration & dosage; Adrenergic beta-Agonists - therapeutic use; Adult; Aged; Albuterol - administration & dosage; Albuterol - analogs & derivatives; Albuterol - therapeutic use; Asthma - drug therapy; Biological and medical sciences; Ethanolamines - administration & dosage; Ethanolamines - therapeutic use; Female; Formoterol Fumarate; Humans; Male; Medical sciences; Middle Aged; Peak Expiratory Flow Rate - drug effects; Pharmacology. Drug treatments; Respiratory system; Salmeterol Xinafoate; Time Factors
• ISSN: 0954-6111; 1532-3064
• DOI: 10.1016/S0954-6111(98)90385-7

The aim of this randomized, open, parallel group study was to compare the clinical efficacy of formoterol dry powder capsule 12 μg b.i.d. and salmeterol dry powder 50 μg b.i.d. in the treatment of patients with reversible obstructive airways disease. The 6-month treatment was preceded by a 2 week run-in period. Morning pre-dose peak expiratory flow (PEF) during the last 7 days of treatment was the primary variable. Throughout the study, patients recorded morning and evening pre-dose PEF, use of rescue medication, respiratory symptoms and adverse events. Clinic visits were scheduled at monthly intervals. Of the 482 patients randomized (equal numbers in the two treatment groups), 428 completed the study. Four hundred and twenty-five patients were included in the efficacy analysis for the primary variable. For mean morning pre-dose PEF during the last 7 days of treatment, the 95% confidence interval (CI) for the treatment contrast formoterol minus salmeterol was included entirely in the pre-defined range of equivalence (CI limits = −8·69, +9·84 l min −1). This was also the case for the morning PEF during the last week before each clinic visit. For mean evening pre-dose PEF, the estimated treatment contrasts showed a trend towards superiority of formoterol over salmeterol, which became statistically significant at 2, 3 and 4 months ( P