SMART - Asthma

Be SMART with Asthma

Have you heard of SMART?

SMART stands for Single Maintenance and Reliever Therapy and is currently recommended in patients 4 years of age and older with moderate to severe asthma. This type of asthma treatment involves the use of one inhaler that includes an inhaled corticosteroid (ICS) and a long-acting beta agonist (LABA), specifically formoterol, for both maintenance and reliever therapy.

Medications
ICS-LABA (formoterol) Combinations on the Market	Notes
Symbicort®™ (budesonide/formoterol)	Preferred for SMART; extensively studied
Dulera®™ (mometasone/formoterol)	Can be used for SMART; not currently studied

According to the Asthma Management Guidelines updated in 2020 by the National Heart, Lung, and Blood Institute (NHLBI), patients on daily ICS-LABA treatment plus as needed short-acting beta agonist (SABA) that are uncontrolled may benefit from SMART. Evidence supports switching to SMART at the same or lower maintenance ICS-LABA dose before considering a step up in maintenance treatment. If patients are well controlled on the ICS-LABA plus SABA treatment, SMART may offer less added benefit; thus, the regimen should be maintained. Additionally, the Global Initiative for Asthma (GINA) guidelines were updated in May of 2024 to clarify and continue support for SMART for moderate to severe asthma from its initial inclusion in the December 2022 update of the GINA guidelines.

Trial Data
Clinical Trial	Drugs Studied	Test Population	Results	Key Takeaways
SYGMA (Symbicort Given As Needed in Mild Asthma)	SYGMA 1 BID placebo plus prn terbutaline 0.4mg (delivered dose) OR BID placebo plus prn budesonide/formoterol 160mcg/4.5mcg (delivered dose) OR BID budesonide 200mcg plus prn terbutaline 0.4mg (delivered dose) SYGMA 2 BID placebo plus prn budesonide/formoterol 160mcg/4.5mcg (delivered dose) OR BID budesonide 200mg	Adult patients with mild asthma and patients with moderate to severe asthma	* prn budesonide/formoterol was associated with significantly lower severe exacerbation rate (26% reduction) compared to budesonide maintenance in patients previously receiving only prn SABA in both SYGMA 1 and 2 * SYGMA 1- prn budesonide/formoterol was associated with a large 66% reduction in severe exacerbation rate and an increase in time to first severe exacerbation vs prn SABA	Adults may be better protected by switching to prn ICS/formoterol vs prn SABA
Novel START (Novel Symbicort Turbuhaler Asthma Reliever Therapy)	albuterol 100mcg two puffs prn OR budesonide 200mcg BID plus prn albuterol OR budesonide/formoterol 160mg/4.5mcg one puff prn (delivered dose)	Adult patients with mild asthma	* budesonide/formoterol prn was superior to albuterol prn for prevention of asthma exacerbations with a 60% reduction in severe exacerbations	ICS/formoterol was superior to albuterol when used as needed for asthma exacerbations
MANDALA	albuterol 180mcg/budesonide 160mcg OR albuterol 180mcg/budesonide 80mcg OR albuterol 180mcg alone
Evaluation of Budesonide-Formoterol for Maintenance and Reliever Therapy Among Patients With Poorly Controlled Asthma	systematic review and meta-analysis of 5 randomized clinical trials on maintenance ICS-LABA plus SABA reliever compared with SMART using budesonide-formoterol	Adult and adolescent patients with poorly controlled asthma and baseline Asthma Control Questionnaire 5-item version scores of 1.5 or higher	* switching patients with uncontrolled asthma at GINA step 3 to SMART at either step 3 or 4 was associated with a prolonged time to first severe asthma exacerbation, with a 29% reduced risk compared with stepping up to step 4 inhaled corticosteroid-long-acting β2-agonist maintenance plus short-acting β2-agonist reliever * for patients with uncontrolled asthma at step 3 and step 4, switching to SMART was associated with a prolonged time to first severe asthma exacerbation and a 30% reduced risk compared with remaining at the same treatment step	SMART was associated with longer time to first severe asthma exacerbation compared with a step up or continuation of GINA step; this suggests that if an adult or adolescent receiving treatment at GINA step 3 or 4 has poorly controlled asthma, it is preferable to switch to the SMART regimen rather than to step up or continue the GINA treatment step with maintenance inhaled corticosteroid–long-acting β2-agonist plus short-acting β2-agonist reliever therapy.

Based on the current evidence and continued studies, the decrease in medication burden and reduction in medication costs for patients with asthma by utilizing SMART is clinically significant. Here are some important points for all clinicians to keep in mind:

Traditional asthma management uses different medications for maintenance and reliever therapy whereas SMART uses the same medication for BOTH!
SMART may reduce the risk of confusion on which inhaler to use for maintenance or reliever for many patients, especially children.
SMART is part of the National Asthma Education and Prevention Program (NAEPP) and is detailed in the 2020 NHLBI and 2024 GINA guidelines.
If symptoms are well controlled with two inhalers, it is appropriate to maintain that regimen; but SMART is recommended for patients with moderate to severe persistent asthma aged 4 years and older.
SMART medications are FDA approved in patients 12 years or older and guidelines recommend off-label use of SMART in children aged 4 to 11 years.
In relation to the Asthma Medication Ratio (AMR) HEDIS measure, low dose ICS/LABA (formoterol) combinations are considered ‘Asthma Controller Medications’ and, when filled, lead to a higher percentage of ‘Asthma Controller Medications’ over ‘Total Asthma Medications’. This results in a higher AMR compliance rate; thus, the use of only one inhaler for those with moderate to severe asthma may enhance patient compliance while potentially decreasing exacerbations and lowering costs simultaneously.

RESOURCES:

1. Allergy Asthma Network

2. Community.AAFA.Org

3. Allergy Asthma Network.org

4. Gina Pocket Guide (PDF)

5. 2024 Gina Main Report

6. ATS Journals

7. National Library of Medicine

8. JAMA Network

9. Pharmacy Times

10. SPBM.Medicaid.Ohio.Gov

11. SPBM.Medicaid.Ohio.Gov (PDF)

12. SPBM.Medicaid.Ohio.Gov Document Library (PDF)