Salmeterol/fluticasone propionate ( [formula omitted]) in combination in a Diskus ® inhaler (Seretide ®) is effective and safe in the treatment of steroid-dependent asthma

• Published in: Respiratory medicine 1999-12, Vol.93 (12), p.876-884
• Main Authors: Aubier, M., Pieters, W.R., Schlösser, N.J.J., Steinmetz, K-O.
• Format: Article
• Language: English
• Subjects: Administration, Inhalation; Administration, Topical; Adolescent; Adrenergic beta-Agonists - administration & dosage; Adrenergic beta-Agonists - adverse effects; Adult; Aged; Albuterol - administration & dosage; Albuterol - adverse effects; Albuterol - analogs & derivatives; Androstadienes - administration & dosage; Androstadienes - adverse effects; Anti-Asthmatic Agents - administration & dosage; Anti-Asthmatic Agents - adverse effects; Anti-Inflammatory Agents - administration & dosage; Anti-Inflammatory Agents - adverse effects; Asthma - drug therapy; Asthma - physiopathology; Biological and medical sciences; Bronchodilator Agents - administration & dosage; Bronchodilator Agents - adverse effects; Child; Double-Blind Method; Drug Combinations; Drug Therapy, Combination; Female; Fluticasone; Forced Expiratory Volume; Glucocorticoids; Humans; Male; Medical sciences; Middle Aged; Nebulizers and Vaporizers; Peak Expiratory Flow Rate; Pharmacology. Drug treatments; Respiratory system; Salmeterol Xinafoate
• ISSN: 0954-6111; 1532-3064
• DOI: 10.1016/S0954-6111(99)90053-7

This multicentre double-blind, double-dummy study compared the safety and efficacy of a new combination Diskus ® inhaler containing both salmeterol 50 μg and fluticasone propionate 500 μg (Seretide ®, GlaxoWellcome, France) with the same doses of the two drugs delivered via separate Diskus ® inhalers and with the same dose of fluticasone propionate alone. Patients were eligible for study entry if they had received an inhaled corticosteroid continuously for 12 weeks prior to run-in, and had received treatment with beclomethasone dipropionate or budesonide 1500–2000 μg day −1 or fluticasone propionate 750–1000 μg day −1 for at least 4 weeks prior to run-in. In total, 503 patients receiving inhaled corticosteroids were randomized to 28 weeks' treatment with either salmeterol/fluticasone propionate ( 50 500 μ g ) via a single Diskus ® inhaler (combination) and placebo, or salmeterol 50 μg and fluticasone propionate 500μg administered via separate Diskus ® inhalers (concurrent), or fluticasone propionate 500 μg and placebo. All treatments were administered twice daily, mean morning peak expiratory flow rate (PEFR) and asthma symptoms were measured for the first 12 weeks and safety data were collected throughout the 28-week study. Over weeks 1 to 12, improvement in adjusted mean morning PEFR was 35 and 33 l min −1, respectively, in the combination and concurrent therapy treatment groups (12 and 10% increase from baseline, respectively). The mean difference between treatments was −3 l min −1 (90% confidence interval −10·4 l min −1) which was within the criteria for clinical equivalence. However, the combination therapy was statistically significantly superior to fluticasone propionate alone for mean morning PEFR ( P