Salmeterol/fluticasone propionate in a Single Inhaler Device versus theophylline plus fluticasone propionate in patients with COPD

Study objectives. The aim of this study was to compare the relative efficacy in terms of improvement in symptoms and lung function of salmeterol/fluticasone propionate (SLM/FP) combination administered through the Diskus inhaler versus theophylline (THEO) added to FP Diskus in patients with stable chronic obstructive pulmonary disease (COPD). Methods and measurements. Eighty patients were randomized to receive 4 months of treatment in one of two treatment groups: (1) fixed combination of SLM 50 mug and FP 500 mug Diskus, 1 inhalation twice daily; or (2) FP Diskus 500 mug, 1 inhalation twice daily, plus oral titrated THEO twice daily. Patients attended the clinic before and after 4, 8, 12 and 16 weeks of treatment for evaluations of pulmonary function, and dyspnea, which was assessed using an analogic visual scale. Also the supplemental salbutamol use was measured. Results. Sixty-six patients completed the 4-month treatment period: 37 patients receiving SLM/FP and 29 patients receiving THEO + FP. Patients were withdrawn for various reasons, the most common of which were poor compliance with the protocol, exacerbation and GI events. A gradual increase in FEV1 was observed with each treatment. Maximum significant increases in FEV1 over baseline values that were observed after 4 months of treatment were as follows: SLM/FP 0.172 1 (95% CI: 0.084-0.260) and THEO + FP 0.155 1 (95% CI: 0.054-0.256). SLM/FP experienced significantly (p < 0.05) greater improvements in dyspnea, and required significantly fewer supplemental salbutamol treatments than the THEO + FP group. Conclusions. Our results suggest that SLM/FP combination may provide substantial benefits in both physiologic and clinical outcomes in 41 symptomatic patients with COPD. It also causes a more effective control than THEO + FP. (C) 2004 Published by Elsevier Ltd.