Budesonide/formoterol maintenance and reliever therapy versus fluticasone/salmeterol fixed-dose treatment in patients with COPD

Susan Muiser*, Kai Imkamp, Dianne Seigers, Nynke J. Halbersma, Judith M. Vonk, Bart H.D. Luijk, Gert Jan Braunstahl, Jan Willem Van Den Berg, Bart Jan Kroesen, Janwillem W.H. Kocks, Irene H. Heijink, Helen K. Reddel, Huib A.M. Kerstjens, Maarten Van Den Berge

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review


Background Maintenance and reliever therapy (MART) with inhaled corticosteroid (ICS)/formoterol effectively reduces exacerbations in asthma. We aimed to investigate its efficacy compared with fixed-dose fluticasone/salmeterol in chronic obstructive pulmonary disease (COPD). Methods 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 1 year. The primary outcome was rate of moderate/severe exacerbations, defined by treatment with oral prednisolone and/or antibiotics. Results In total, 195 patients were randomised (MART Bud/Form n=103; fixed-dose FSC n=92). No significant difference was seen between MART and FSC therapy in exacerbation rates (1.32 vs 1.32 /year, respectively, rate ratio 1.05 (95% CI 0.79 to 1.39); p=0.741). No differences in lung function parameters or health status were observed. Total ICS dose was significantly lower with MART than FSC therapy (budesonide-equivalent 928 μg/day vs 1747 μg/day, respectively, p<0.05). Similar proportions of patients reported adverse events (MART Bud/Form: 73% vs fixed-dose FSC: 68%, p=0.408) and pneumonias (MART: 5% vs FSC: 1%, p=0.216). Conclusions This first study of MART in COPD found that budesonide/formoterol MART might be similarly effective to fluticasone/salmeterol fixed-dose therapy in moderate to severe patients with COPD, at a lower daily ICS dosage. Further evidence is needed about long-term safety.

Original languageEnglish
Pages (from-to)451-458
Number of pages8
Issue number5
Publication statusPublished - 1 May 2023


  • COPD Exacerbations
  • COPD Pharmacology


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