This protocol addresses patients aged 12 years or older — adolescents and adults — whose asthma has failed to reach adequate control despite Step 4 treatment. When that step is insufficient, a defined escalation pathway for severe asthma applies.
Step 4 therapy — either medium-dose maintenance-and-reliever therapy (MART) with ICS-formoterol, or medium-dose maintenance ICS-LABA — did not achieve well-controlled asthma. The goals that were not met include: absence of troublesome daytime and night-time symptoms, no severe exacerbations, normal or near-normal lung function, and the ability to lead a fully active life.
After Step 4 failure in this age group, management moves to Step 5 for severe asthma. Expert assessment to characterise the patient's phenotype is the key first step, and additional therapies — including biologic options — may be considered on that basis. The complete decision sequence is in the full protocol.