An anti-inflammatory reliever algorithm approach to asthma management in adults: an open-label, single-arm trial.

Background: The stepwise approach to asthma management is a key feature of guidelines, yet knowledge of its implementation in clinical practice is limited. Our objective was to evaluate the implementation of an anti-inflammatory reliever (AIR) stepwise algorithm. Methods: Between December 2020 and July 2022, we conducted a 52-week, open-label, single-arm trial of 100 adults aged 18-75 with asthma, with 25 patients each on Global Initiative for Asthma 2018 treatment steps 1, 2, 3 and 4 at baseline. Patients were assigned to an AIR algorithm, with budesonide-formoterol 200/6 μg, one actuation as-needed (Step 1), one actuation twice-daily plus as-needed (Step 2), or two actuations twice-daily plus one as-needed (Step 3), depending on baseline treatment. Treatment steps were adjusted in response to participant reported reliever use and asthma attacks, according to the AIR algorithm. The primary outcome was Treatment Satisfaction Questionnaire for Medication (TSQM-II) Global Satisfaction score. Secondary outcomes assessed the TSQM-II Global Satisfaction minimal clinically important difference (MCID), efficacy, safety, patterns of medication use, and patient flow through treatment steps. The trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12620001010987). Findings: 100 participants were assigned an AIR treatment step, 68 were female and the mean age was 48 (range 19-75). There was a significant increase in TSQM-II Global Satisfaction at week 52 compared with baseline, mean (SD) 84.3 (18.6) compared to 78.1 (14.7); difference 6.3 (95% CI 1.7-10.9), p = 0.007. The estimated MCID for this variable was 3.0 (95% CI 0.2-5.7). There was a transition to lower treatment steps, with 60% (56/94), 31% (29/94), and 10% (9/94) on Steps 1, 2, and 3 at week 52 compared with 25% (25/100), 50% (50/100), and 25% (25/100) at baseline, respectively. There was a reduction in Asthma Control Questionnaire-5 at week 52 compared with baseline, mean (SD) 0.8 (0.7) compared to 1.0 (0.8); difference -0.22 (95% CI -0.39 to -0.05). There were four serious adverse events unrelated to treatment, including one death due to an acute cardiac event. Interpretation: The adoption of the AIR Algorithm in adults with asthma was associated with enhanced patient satisfaction and asthma control. Funding: Medical Research Institute of New Zealand (Independent Research Organisation funding from the Health Research Council of New Zealand [IRO grant 18/002]) and AstraZeneca.