- A study published in NEJM May 2019, Controlled Trial of Budesonide-Formoterol as Needed for Mild Asthma, contributed to a major change in the Global Initiative of Asthma (GINA) recommendations.
Brief Study Overview
- This was a 52-week, randomized, open-label, parallel-group, controlled trial which was conducted at 16 trial centers in New Zealand, UK, Italy and Australia.
- It looked at 3 treatment arms
- Albuterol PRN for symptoms
- Budesonide maintenance + Albuterol PRN for symptoms
- Budesonide-formoterol PRN for symptoms
- The Primary outcome was the annualized rate of asthma exacerbations per patient. Exacerbation was defined as worsening asthma that resulted in:
- an urgent medical care consultation (primary care office, ED visit or hospitalization)
- a prescription of systemic glucocorticoids for any duration or
- an episode of high b-agonist use
- Results: The asthma exacerbation rate and risk of exacerbation in the budesonide-formoterol PRN group was lower than that in the albuterol group and did not differ significantly from the budesonide maintenance group.
- The new finding in this study (as compared to the SYGMA 1 and SYGMA 2 trials in 2018) was that the number of severe exacerbations in the budesonide-formoterol group was lower than the number in both the albuterol group and the budesonide maintenance group.
So what has changed?
- The latest guidelines from GINA in 2019 do not recommend a short acting beta 2-agonist (SABA) alone a rescue inhaler.
- Instead, all adults and adolescents are now recommended to have ICS-containing controller treatment in mild asthma to prevent risk of serious exacerbations and to help control symptoms.
1. Bateman E., Reddel, H., O’Byrne, P. (2018) As needed Budesonide-Formoterol versus Maintenance Budesonide in Mild Asthma. The New England Journal of Medicine. 378 (20) 1877-1887
2. O’Byrne P, FitzGerald, M, Bateman E. (2018) Inhaled Combined Budesonide-Formoterol as Needed in Mild Asthma. The New England Journal of Medicine. 378 (20) 1865-1876
3. Beasley R., Holliday M., Reddel H. (2019) Controlled Trial of Budesonide-Formoterol as Needed for Mild Asthma. The New England Journal of Medicine. 380 (21) 2020-2030.
4. Pocket Guide for Asthma Management and Prevention. Global Initiative of Asthma.
Post reviewed and edited by @udaygulati