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

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). Patients with COPD and ≥1 exacerbati...

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Bibliographic Details
Published in:	Thorax Vol. 78; no. 5; p. 451
Main Authors:	Muiser, Susan, Imkamp, Kai, Seigers, Dianne, Halbersma, Nynke J, Vonk, Judith M, Luijk, Bart H D, Braunstahl, Gert-Jan, van den Berg, Jan-Willem, Kroesen, Bart-Jan, Kocks, Janwillem W H, Heijink, Irene H, Reddel, Helen K, Kerstjens, Huib A M, van den Berge, Maarten
Format:	Journal Article
Language:	English
Published:	England 01-05-2023
Subjects:	Adrenal Cortex Hormones - therapeutic use Androstadienes - adverse effects Bronchodilator Agents - therapeutic use Budesonide - adverse effects Budesonide, Formoterol Fumarate Drug Combination - therapeutic use Drug Combinations Ethanolamines - adverse effects Fluticasone-Salmeterol Drug Combination - therapeutic use Formoterol Fumarate - therapeutic use Humans Pulmonary Disease, Chronic Obstructive - drug therapy Treatment Outcome COPD Exacerbations COPD Pharmacology
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Summary:	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). 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. 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). 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.
ISSN:	1468-3296
DOI:	10.1136/thorax-2022-219620