Rethinking Mild Asthma in Primary Care: Real-World Lessons on As-Needed ICS-SABA Use

Up to three-quarters of people with asthma have symptoms typically described as ‘mild’. However, such patients may not have their symptoms fully controlled and may experience dangerous exacerbations. Although the latest Global Initiative for Asthma (GINA) report recommends that all patients with asthma take low-dose inhaled corticosteroids (ICS) whenever a short-acting β2-agonist (SABA) is administered (either as a combination therapy or in separate inhalers), many are still prescribed SABA therapy alone, which is not recommended by GINA. While inhaled SABAs are highly effective for the quick relief of asthma symptoms, patients whose asthma is treated with SABA alone (compared to those taking an ICS, either as daily maintenance or as-needed in combination with SABA) are at an increased risk of asthma-related death and need for urgent asthma-related healthcare, even if they have good symptom control. Here, three experts in the field discuss evidence-based approaches to help patients living with mild asthma, along with the design of and results from the Phase IIIb BATURA trial. This trial investigated the efficacy and safety of as-needed use of an albuterol-budesonide (ALB-BUD) pressurized metered dose inhaler (pMDI) compared with albuterol sulfate (ALB) alone in adolescents ≥12 years and adults with mild asthma. The trial was fully decentralized and virtual, meaning all study procedures were done from home and patients did not have to give up time and money to travel to a study site to participate. The decentralized design also facilitated the inclusion of an ethnic and racial makeup of patients more representative of the US, which, the experts discussed, may not always be the case in clinical trials. However, the virtual design also meant that patients were not phenotyped, and that outcomes were reported remotely. Results included a significant 47% reduction in the annual risk of a severe exacerbation with ALB-BUD compared with ALB alone (p<0.001). The results also showed a reduction in the use of systemic glucocorticoids, use of which leads to adverse effects. As patients with mild asthma are typically seen by primary care practitioners (PCP), the experts agreed that the BATURA trial results potentially provide a simple way to help patients control symptoms and mitigate future adverse outcomes in the primary care setting using an as-needed ICS-SABA combination.