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

Mario Cazzola, Paolo Noschese, Stefano Centanni, Pierachile Santus, Fabiano Di Marco, Lucia Spicuzza, Giuseppe Ugo Di Maria

Research output: Contribution to journalArticlepeer-review


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 μg and FP 500 μg Diskus, 1 inhalation twice daily; or (2) FP Diskus 500 μg, 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 Patients were withdrawn for various reasons, the most common of which were poor compliance with the protocol, exacerbation and GI events.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 l (95% CI: 0.084-0.260) and THEO+FP 0.155 l (95% CI: 0.054-0.256). SLM/FP experienced significantly (p

Original languageEnglish
Pages (from-to)141-145
Number of pages5
JournalPulmonary Pharmacology and Therapeutics
Issue number3
Publication statusPublished - Jun 2004


  • Chronic obstructive pulmonary disease
  • Combination therapy
  • Fluticasone propionate
  • Salmeterol
  • Theophylline

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine
  • Pharmacology


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