Table 1.

GINA Step Assignment (Adapted from GINA 2019)

Step	Definition
1	No maintenance therapy
2	Low dose ICS only Oral controller** only
3	Low dose ICS + LABA and/or oral controller Medium dose ICS only
4	Medium dose ICS/LABA Medium/high dose ICS + LABA and/or oral controller Low dose ICS + LABA + LAMA
5	Any high dose ICS + OCS* Any ICS/LABA + OCS* Any medium/high dose ICS/LABA + LAMA (Triple***) Biologics

Notes: *OCS: Only prescriptions of low dose and high pack size were included to restrict to maintenance therapy, rather than acute high dose use. **: LTRA and theophylline (rarely used). ***: At the time of the study, no fixed triple treatments were approved for asthma in Germany. Classification makes no distinction between free or fixed combination options whereby fixed ICS/LABA is more prevalent than free combinations. Children’s classification was done by the same rules as for adults. Differences are nuanced in step 4 and could not be resolved in RWD. Differences mainly arise from different ICS dosage thresholds translating into low/medium/high daily dose. High dose ICS/LABA in the absence of add-on (Biologic, OCS, LAMA) was not classified as GINA 5 as ICS daily dose is estimated from refill distances with some uncertainty. In the further steps of the study, GINA 4 and GINA 5 patients were analyzed as one group.

Abbreviations: ICS, inhaled corticosteroids; LABA, long-acting β2-agonist; LAMA, long-acting muscarinic antagonist; OCS, oral corticosteroid.