- Jennifer Middleton, MD, MPH
The most recent global asthma guidelines advocate against the routine use of short-acting beta agonists (SABAs) for patients with mild asthma, and now a randomized controlled trial (RCT) has found that albuterol (a SABA) was inferior to beclomethasone, an inhaled corticosteroid (ICS), for acute symptom control in persons with asthma regardless of baseline asthma severity.
The researchers only enrolled Black and Latinx patients in this RCT, acknowledging that "guideline recommendations have not been based on studies in these populations." They randomized 1201 outpatients with moderate-to-severe asthma to either albuterol (usual care) or beclomethasone (intervention group) for acute symptom relief and followed them for 15 months. They found that "[t]he annualized rate of severe asthma exacerbations was 0.69 (95% confidence interval [CI], 0.61 to 0.78) in the intervention group and 0.82 (95% CI 0.73 to 0.92) in the usual-care group (hazard ratio, 0.85; 95% CI, 0.72 to 0.999; P=0.048)." Asthma symptoms and missed days of work, both secondary outcome measures in the study, also favored the beclomethasone intervention group.
In 2020, the Global Initiative for Asthma (GINA) guidelines recommended against SABA use as monotherapy for mild asthma, citing data showing increased mortality and exacerbations in patients who only used albuterol for even mild asthma symptoms. The GINA guidelines instead recommend the use of an ICS in combination with formoterol, a long-acting beta agonist (LABA), for acute relief of asthma symptoms in all patients with asthma, regardless of baseline severity. The guidelines do list use of an as-needed SABA as an acceptable option for patients on an ICS already at baseline; this newest study suggests that, even in those patients, SABAs are inferior to ICS for acute symptoms.
Switching from albuterol to either ICS or ICS/LABA inhalers will require substantial changes in the US from both the Food and Drug Administration (FDA) and insurance companies. Symbicort, the only ICS/formoterol product currently FDA-approved in the US, is not FDA-approved for as needed use. Symbicort comes with 60 doses per inhaler; insurance companies in the US do not typically cover more than 1 inhaler a month, which may be sufficient for patients who do not need treatment daily, but patients with more severe asthma could easily exceed 60 doses in a month using it for both daily control and as needed. Without insurance, Symbicort costs at least $200/month and is not available yet as a generic; even with insurance, many patients pay significant co-pays. Beclomethasone (Qvar) is also quite expensive, costing at least $200 per inhaler.
Advocating for these changes was precisely what the RCT researchers intended, according to the study registry on clinicaltrials.gov:
The investigators have consulted with AA [African American] and H/L [Hispanic/Latinx] patients, health care providers, leaders of professional societies, advocacy groups, health policy leaders, pharmacists, and pharmaceutical manufacturers. All groups have indicated that asthma decision making would be changed if it was demonstrated that implementing PARTICS [Patient Activated Reliever-Triggered Inhaled CorticoSteroid] improves important asthma outcomes such as reducing rates of exacerbations.
The researchers' efforts to partner with patients and advocacy groups is laudable, and hopefully this study helps to spur needed change in asthma inhaler affordability and access.
If you'd like to read more, this AFP article on "Asthma: Updated Diagnosis and Management Recommendations from GINA" provides a useful overview of the GINA recommendations, which is included in the AFP By Topic on Asthma.
