6/28/23, 10:34 PM FAST Pathway Feedback Search Clinical Topics Home Studies FAST FAST Disease Disease Asthma Severe asthma phenotypes Trial question What is the effect of temporary quadrupling of the dose of ICSs in patients who had a severe asthma exacerbation? Study design Multi-center Open label RCT Population Characteristics of study participants 68.0% female N = 1922 32.0% male 1922 patients (1305 female, 617 male) Inclusion criteria: adult and adolescent patients with asthma who were receiving ICSs, with or without add-on therapy, and who had at least one exacerbation in the previous 12 months Key exclusion criteria: history of smoking related to COPD, on maintenance oral corticosteroids, use of a corticosteroid/long-acting bronchodilator combination inhaler for both maintenance and relief treatment, an exacerbation within four weeks of randomization, pregnancy Interventions N=957 quadrupling (increased bronchodilator medication and an increase in the dose of ICSs by a factor of 4) N=965 non-quadrupling (increased bronchodilator medication alone) Primary outcome https://web.pathway.md/studies/recXmW9eKC1LTalZj 1/2 6/28/23, 10:34 PM FAST Pathway Use of systemic corticosteroids 40.0 % 40 33 30.0 % 20.0 % 10.0 % Borderline significant decrease 0.0 % Quadrupling Non-quadrupling Borderline significant decrease in use of systemic corticosteroids (33% vs. 40%; RR 0.82, 95% CI 0.7 to 0.96) Secondary outcomes Borderline significant decrease in unscheduled healthcare consultation (41% vs. 47%; RR 0.86, 95% CI 0.75 to 0.99) Significant increase in mean AUC of the peak flow (1166 L/min/day vs. 1130 L/min/day; AD 38 L/min/day, 95% CI 13 to 62) Safety outcomes No significant difference in pneumonia or lower respiratory tract infection. Significant difference in serious adverse events (2% vs. 4%) and nonserious adverse events (7% vs. 2%). Conclusion In adult and adolescent patients with asthma who were receiving ICSs, with or without add-on therapy, and who had at least one exacerbation in the previous 12 months, quadrupling was superior to non-quadrupling with respect to use of systemic corticosteroids. Reference McKeever T, Mortimer K, Wilson A et al. Quadrupling Inhaled Glucocorticoid Dose to Abort Asthma Exacerbations. N Engl J Med. 2018 Mar 8;378(10):902-910. Open reference URL https://web.pathway.md/studies/recXmW9eKC1LTalZj 2/2