RT Journal Article
SR Electronic
T1 Budesonide/formoterol maintenance and reliever therapy versus fluticasone/salmeterol fixed-dose treatment in patients with COPD
JF Thorax
JO Thorax
FD BMJ Publishing Group Ltd and British Thoracic Society
SP 451
OP 458
DO 10.1136/thorax-2022-219620
VO 78
IS 5
A1 Susan Muiser
A1 Kai Imkamp
A1 Dianne Seigers
A1 Nynke J Halbersma
A1 Judith M Vonk
A1 Bart H D Luijk
A1 Gert-Jan Braunstahl
A1 Jan-Willem van den Berg
A1 Bart-Jan Kroesen
A1 Janwillem W H Kocks
A1 Irene H Heijink
A1 Helen K Reddel
A1 Huib A M Kerstjens
A1 Maarten van den Berge
YR 2023
UL http://thorax.bmj.com/content/78/5/451.abstract
AB 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.Data are available on reasonable request. Please contact the corresponding author in case of interest in potential data access.