ERJ open research · 2026
Airway inflammation and asthma control in patients using salbutamol or budesonide/formoterol reliever: a randomised, controlled study.
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Martin Matthew J, Pavord Ian D, Chalmers James D, Saralaya Dinesh, Roy Kay G, Patel Manish, Clarke Graham W, Belton Laura, Rutgersson Annika, Gustafson Per, Raja Gopal Vieshal, Harrison Tim
Аннотация
BACKGROUND: Maintenance and reliever therapy (MART) with budesonide/formoterol (BUD/FORM) may offer asthma control with a single inhaler. This 6-month exploratory study monitored asthma symptoms, reliever use, lung function, airway inflammation and exacerbation events to determine treatment effectiveness in patients receiving BUD/FORM MART or BUD/FORM maintenance therapy plus short-acting β2-agonist (SABA).
METHODS: In the open-label STIFLE study (NCT03924635), patients were randomised to BUD/FORM MART (100 μg/6 μg or 200 μg/6 μg per inhalation, pro re nata (PRN)) or the same dose of BUD/FORM BID as maintenance therapy plus SABA (salbutamol) reliever PRN (100 μg per inhalation). Data were captured at home each day using devices connected to a smartphone via the STIFLE application. Occurrence of pre-defined exacerbation events required patients to attend hospital for assessment.
RESULTS: 42 patients were randomised. Adherence to daily measurements exceeded 80% in both treatment groups. The proportion of patients experiencing an exacerbation was 27.8% in the BUD/FORM MART versus 70.8% in the BUD/FORM maintenance plus SABA group. A similar trend was observed in patients who experienced ≥1 day with ≥6 reliever uses (3 (16.7%) versus 9 (37.5%) patients, respectively). Patients treated with BUD/FORM MART showed less variation in airway inflammation, asthma symptom scores, lung function parameters and reliever use, versus BUD/FORM maintenance therapy plus SABA. No unexpected safety findings were observed.
CONCLUSIONS: Patients with moderate asthma treated with BUD/FORM MART recorded less variation in asthma outcomes and lower rates of exacerbation events than those treated with BUD/FORM maintenance therapy plus SABA, suggesting improved asthma control.
METHODS: In the open-label STIFLE study (NCT03924635), patients were randomised to BUD/FORM MART (100 μg/6 μg or 200 μg/6 μg per inhalation, pro re nata (PRN)) or the same dose of BUD/FORM BID as maintenance therapy plus SABA (salbutamol) reliever PRN (100 μg per inhalation). Data were captured at home each day using devices connected to a smartphone via the STIFLE application. Occurrence of pre-defined exacerbation events required patients to attend hospital for assessment.
RESULTS: 42 patients were randomised. Adherence to daily measurements exceeded 80% in both treatment groups. The proportion of patients experiencing an exacerbation was 27.8% in the BUD/FORM MART versus 70.8% in the BUD/FORM maintenance plus SABA group. A similar trend was observed in patients who experienced ≥1 day with ≥6 reliever uses (3 (16.7%) versus 9 (37.5%) patients, respectively). Patients treated with BUD/FORM MART showed less variation in airway inflammation, asthma symptom scores, lung function parameters and reliever use, versus BUD/FORM maintenance therapy plus SABA. No unexpected safety findings were observed.
CONCLUSIONS: Patients with moderate asthma treated with BUD/FORM MART recorded less variation in asthma outcomes and lower rates of exacerbation events than those treated with BUD/FORM maintenance therapy plus SABA, suggesting improved asthma control.