As-Needed Albuterol-Budesonide in Mild Asthma

Investigate the efficacy of as-needed albuterol-budesonide to lower the risk of severe asthma exacerbations in patients with mild asthma compared with albuterol alone.The study included patients aged 12 years and older, diagnosed with mild asthma (National Asthma Education and Prevention Program [NAEPP] Step 1 or 2) that was uncontrolled while using albuterol as needed with or without low-dose inhaled glucocorticoid or leukotriene receptor antagonists.This was a double-blind, randomized, fully virtual trial using parallel groups with event-driven endpoints. Participants were randomly assigned in a 1:1 fashion to use albuterol 180 μg–budesonide 160 μg or albuterol 180 μg as needed for between 12 and 52 weeks. The primary endpoint of this study was time to first severe asthma exacerbation, with secondary endpoints of annualized rates of severe asthma exacerbations and use of systemic glucocorticoids. Safety endpoints included the types and frequency of adverse events. Severe exacerbation was defined as worsening symptoms resulting in at least 3 days of systemic glucocorticoid use or hospital-reported evidence of needing treatment for exacerbation. Participants were observed for up to 52 weeks.A total of 1797 participants completed the trial. There was a statistically significant difference between the 2 treatment groups, with 5.1% of albuterol-budesonide participants experiencing severe exacerbation relative to 9.1% of albuterol participants. The albuterol-budesonide group demonstrated a lower mean annualized total exposure to glucocorticoids than the albuterol-alone group. The rate of adverse events did not differ between the 2 groups.This trial demonstrated the efficacy of as-needed albuterol-budesonide in prevention of severe asthma exacerbation for patients with mild asthma.As-needed albuterol-budesonide combination inhaler therapy can be a valuable tool for pediatricians. Less than 3% of the participants in this study were aged 12 to 18 years, and trials are underway in this age group specifically. Further studies should also compare this treatment option with other as-needed inhalers and daily therapies in safety and efficacy.