[Efficacy and safety of salmeterol (50 microgram) and fluticasone (250 microgram) in a single inhaler device (diskus) in patients with mild to moderate asthma]. / Wirksamkeit und Verträglichkeit einer festen Kombination von Salmeterol (50 microgram)/Fluticason (250 microgram) in einem einzigen Inhalationssystem (Diskus) bei Patienten mit leicht- bis mittelgradigem Asthma bronchiale.

ABSTRACT

BACKGROUND: Inhaled corticosteroids and long-acting beta-agonists are first-line agents for the treatment of patients with persisting bronchial asthma. Several lines of evidence have shown, that inhaled corticosteroids and long-acting beta-agonist have multiple synergisms both in vivo and in vitro, leading to improved clinical asthma control. METHODS: A prospective, open, multi-centre study was performed to evaluate the efficacy and safety of a fixed combination of inhaled Fluticasone (250 microgram BID) and Salmeterol (50 microgram BID) in a single inhaler device (Diskus). 3345 patients (48 % male, mean age 52 years, range 17 - 90 years) with mild to moderate asthma were treated over a period of 8 weeks. Lung function, quality of life and adverse events were evaluated as primary outcome variables. RESULTS: After 8 weeks of treatment, forced expiratory volume in one second (FEV1) improved from 2.37 +/- 0.86 l to 2.7 +/- 0.96 l (p < 0.001). Accordingly, morning peak expiratory flow (PEF) increased from 4.9 +/- 2.1 l/s to 5.6 +/- 2.2 l/s (p < 0.001). Quality of life improved in 90 % of all patients, with an overall increase of 1.1. points. Frequent adverse events included symptoms of asthma (5.3 % of all adverse events) and infections (2.7 %). Typical side-effects of the study medication, e. g. oral candidiasis or tachycardia were observed in less than 2 % of all patients. CONCLUSIONS: These results confirm the efficacy and tolerability of a fixed combination of salmeterol and fluticasone in a single inhaler device (Diskus). Lung function and quality of life were significantly improved in mild to moderate asthmatics. A fixed combination of long-acting beta-agonists and inhaled corticosteroids is therefore considered as a valuable therapeutic option for the treatment of patients with asthma.