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. 2021 Jan 12;5:6. doi: 10.1186/s41687-020-00274-x

Table 1.

Definitions of moderate and severe exacerbations used in the MT-04 trial

Criteria defining moderate exacerbations [24] Criteria defining severe exacerbations [13]

1 or more of the following criteria and must also result in a temporary change in treatment:

● Nocturnal awakening(s) due to asthma requiring SABA use for at least 2 consecutive nights or an increase of at least 0.75 points in daily symptom score from baseline value on at least 2 consecutive days;

● An increase from baseline in SABA use on at least 2 consecutive days (a minimum increase of 4 puffs per day);

● A 20% or more decrease in peak expiratory flow from baseline on at least 2 consecutive mornings or evenings or a 20% or more decrease in FEV1 from baseline;

● A visit to the emergency department or an unscheduled visit to the trial site for asthma treatment not requiring systemic corticosteroids.

1 or more of the following criteria:

● A requirement for systemic corticosteroids for the treatment of asthma symptoms for at least 3 days;

● An emergency department visit due to asthma requiring systemic corticosteroids, or a hospitalization for more than 12 h due to asthma.

FEV1 Forced Expiratory Volume in 1 s, SABA Short-acting β2-agonists