SOURCE: a phase 3, multicentre, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy and safety of tezepelumab in reducing oral corticosteroid use in adults with oral corticosteroid dependent asthma

Table 2 Asthma control criteria required for OCS dose reduction

Criteria	Definition of asthma control
1	Morning PEF ≥ 80% of mean^a morning measures compared with mean baseline^b measures
2^c	Increase of ≤ 2 nights with asthma-related awakenings (requiring rescue medication) over a 7-day period compared with baseline^b
3	Mean^a SABA rescue medication use ≤ 4 puffs/day above the baseline^b mean and < 12 puffs/day on all days in the previous 14 days
4	No asthma exacerbation requiring increased systemic corticosteroids or hospitalization since the previous visit
5	Investigator judges the patient’s asthma control to be sufficient to allow OCS dose reduction
6	No signs/symptoms of adrenal insufficiency (at OCS dose reductions < 5 mg)

^aMean values considered for each down-titration visit will be from electronic diary records completed for 14 days before the visit
^bBaseline values for the optimization phase will be calculated from electronic diary records completed for ≥ 10 out of 14 days before visit 2. Similarly, baseline values for the reduction phase will be calculated from ≥ 10 out of 14 days of data collected before the randomization visit
^cThe number of nights with asthma-related awakenings requiring rescue medication will be counted from the most recent 7 days of available data
OCS Oral corticosteroid, PEF Peak expiratory flow, SABA Short-acting β₂ agonist

ISSN: 1465-993X