Maintenance and reliever therapy with budesonide/formoterol versus fixed dose fluticasone/salmeterol in patients with COPD

Abstract

<b>Background:</b> Maintenance and reliever therapy (MART) with inhaled corticosteroid (ICS)/formoterol effectively reduces exacerbations in asthma. We investigated its efficacy compared to fixed-dose fluticasone/salmeterol in COPD. <b>Methods:</b> Patients with COPD and ≥1 exacerbation in the previous 2 years were randomly assigned to open-label MART (Spiromax® budesonide/formoterol 160/4.5 µg 2 inhalations twice daily + 1 prn) or fixed-dose therapy (Diskus® fluticasone propionate/salmeterol combination (FSC) 500/50 µg 1 inhalation twice daily + salbutamol 100 μg prn) for one year in a multicentre study. The primary outcome was the rate of moderate/severe exacerbations, defined by treatment with oral prednisolone and/or antibiotics. <b>Results:</b> 195 patients were randomised (MART Bud/Form n=103; fixed-dose FSC n=92). No significant difference in exacerbation rate was found between MART and FSC (1.32 vs 1.32/year, respectively; rate ratio 1.05 [95% CI 0.79-1.39], p=0.74). No differences in lung function parameters or health status were observed, except for a trend towards increased hyperinflation with FSC and a trend towards higher COPD Assessment Test score with MART. The total administered ICS dose was significantly lower with MART than with FSC (budesonide-equivalent 928 µg/day vs 1747 µg/day, respectively; p&lt;0.05). Similar proportions of patients reported adverse events (MART: 73% vs FSC: 68%, p=0.41) and pneumonias (MART: 5% vs FSC: 1%, p=0.22). <b>Conclusion:</b> This first study of MART in COPD found that budesonide/formoterol MART is similarly effective as fluticasone/salmeterol fixed-dose therapy in moderate-severe COPD patients, at a lower daily inhaled corticosteroid dosage.