Inhaled salmeterol/fluticasone propionate combination in chronic obstructive pulmonary disease.

Salmeterol/fluticasone propionate is a fixed-dose combination of the long-acting beta2-adrenoceptor agonist salmeterol and the corticosteroid fluticasone propionate and is inhaled via the Diskus powder inhaler. In three randomized, double-blind, 24-week or 52-week studies in >2850 patients with chronic obstructive pulmonary disease (COPD), administration of salmeterol/fluticasone propionate 50/250 microg twice daily (in one study) and salmeterol/fluticasone propionate 50/500 microg twice daily (in the other studies) provided greater improvement in lung function than placebo or either component alone at the same nominal dosage. Both strengths of the combination product administered twice daily resulted in clinically meaningful increases in scores in health-related quality-of-life questionnaires that were specific for respiratory disease. Improvements in this and almost all other secondary measures of efficacy, including symptomatic outcomes, were significantly greater with the combination product than with placebo. Administration of salmeterol/fluticasone propionate as a combination product did not result in any untoward interactions that affected the pharmacodynamic, pharmacokinetic or tolerability profiles of the individual components. Candidiasis, hoarseness/dysphonia, throat irritation and headache occurred more frequently with salmeterol/fluticasone propionate than with placebo in patients with COPD.

RCT Entities:   Population Interventions Outcomes