Praxis Medical Insights

Est. 2024 • Clinical Guidelines Distilled

Made possible by volunteer editors from the University of Calgary & University of Alberta

Last Updated: 9/17/2025

ICS/Formoterol for Asthma Exacerbations

Rationale for ICS/Formoterol as Preferred Reliever Therapy

  • The American College of Allergy, Asthma, and Immunology recommends ICS/formoterol used as both maintenance and reliever therapy (SMART) for patients ≥5 years old with mild to moderate asthma at steps 3 and 4 of treatment 1, 2
  • Formoterol has a rapid onset of action similar to SABAs, making it effective for quick symptom relief 1
  • Studies of SMART were primarily performed with budesonide/formoterol, showing superior outcomes compared to SABA alone 2

Comparison of Options

  • The 2020 National Asthma Education and Prevention Program (NAEPP) guidelines specifically recommend ICS/formoterol as both maintenance and reliever therapy for steps 3 and 4 3
  • ICS alone lacks the rapid bronchodilator effect needed for immediate symptom relief during exacerbations, according to the American Thoracic Society 4, 5
  • Long-acting beta-agonists (LABAs) including formoterol should not be used as monotherapy for asthma, as stated by the American Academy of Allergy, Asthma, and Immunology 4, 5
  • Formoterol monotherapy lacks the anti-inflammatory component needed to address the underlying pathophysiology of asthma, as noted by the European Respiratory Society 7

Important Clinical Considerations

  • Formoterol is the preferred LABA for reliever therapy due to its rapid onset of action; salmeterol has a slower onset and should not be used for this purpose, according to the Global Initiative for Asthma 2
  • Although the boxed warning regarding asthma-related death has been removed from ICS/LABA labels, SMART is technically an off-label use in the United States, as stated by the Food and Drug Administration 2
  • The evidence primarily supports budesonide/formoterol for this indication, though theoretically other ICS formulations combined with formoterol could be effective, as suggested by the National Institutes of Health 2
  • For patients with mild asthma (step 2), as-needed ICS/formoterol or concomitant ICS and SABA are both acceptable alternatives to daily low-dose ICS with SABA as needed, according to the American College of Chest Physicians 3

Potential Pitfalls and Caveats

  • Ensure patients understand which inhaler to use as a reliever versus maintenance therapy when using the SMART approach, as recommended by the American Academy of Allergy, Asthma, and Immunology 2
  • Insurance coverage may be a barrier as some plans may not cover two canisters of the same ICS/LABA at once (one for maintenance, one for relief), as noted by the National Association of Insurance Commissioners 2