Study Supports Recent Change in GINA Guidelines

Stepping outside for air, running on the treadmill to exercise, experiencing strong emotions—the triggers for asthma are unavoidable and integrated into daily life. Thus, for the 25 million Americans whose lungs are hyperreactive to myriad triggers, pharmacotherapy is essential to reverse chest tightening, labored breathing, and constant coughing.¹

The New England Journal of Medicine published a recent study demonstrating that budesonide-formoterol is superior to albuterol for as-needed exacerbation prevention in mild asthma. Budesonide is an inhaled corticosteroid (ICS) and formoterol is a long acting beta agonist (LABA), whereas albuterol is a short acting beta agonist (SABA).

The researchers compared the 2 therapies in a randomized, open-label, parallel-group trial over 52 weeks. The 668 patients included in the analysis were adults diagnosed with mild asthma. The inclusion criteria required the sole use of a SABA in the 3 months leading up to the study, at a specified frequency in the last 4 weeks.²

The yearly exacerbation rate and the frequency of severe exacerbations were both lower in the patients using the budesonide-formoterol therapy. These findings parallel the new Global Initiative for Asthma (GINA) guidelines released in 2019. The GINA guidelines state, “In adults and adolescents with mild asthma, treatment with as-needed low dose ICS-formoterol reduces the risk of severe exacerbations by about two-thirds compared with SABA-only treatment...”³

Inhaled corticosteroids are an integral part of moderate to severe asthma management and these findings suggest that they offer benefits even in mild cases.

Furthermore, researchers compared the as-needed use of budesonide-formoterol to a scheduled, twice-daily budesonide regimen combined with as-needed albuterol therapy. Efficacy was similar. Therefore, it is not necessary to administer inhaled corticosteroids on a scheduled basis to achieve maximal relief from mild asthma symptoms. Rescue use is sufficient.

Historically, as-needed albuterol was the go-to therapy for mild asthma exacerbation management. However, as this study and the new GINA guidelines suggest, experts are moving toward the initiation of an ICS-LABA combination for rescue instead. Thus, it is important to keep this emerging regimen in mind, as other guidelines and practices begin to adapt it.

Kamilla Borsai is a 2021 PharmD Candidate at the University of Connecticut School of Pharmacy in Storrs.

REFERENCES

• Asthma Research — Asthma Facts and Figures. Asthma and Allergy Foundation of America website. https://www.aafa.org/asthma-facts/. Updated June 2019. Accessed November 1, 2019.
• Beasley, R, Holliday M, Reddel HK, et al. Controlled Trial of Budesonide—Formoterol as Needed for Mild Asthma. N Engl J Med 2019; 380:2020-2030 DOI: 10.1056/NEJMoa1901963 https://www.nejm.org/doi/full/10.1056/NEJMoa1901963. Accessed November 1, 2019.
• “2019 GINA Main Report — Global Strategy for Asthma Management and Prevention” Global Initiative for Asthma, (2019) 43.