Airway inflammation and asthma control in patients using salbutamol or budesonide/formoterol reliever: a randomised, controlled study

Background Maintenance and reliever therapy (MART) with budesonide/formoterol (BUD/FORM) may offer asthma control with a single inhaler. This six-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 β 2 -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.