Symbicort SMART Therapy
Symbicort SMART (Single Maintenance And Reliever Therapy) is an evidence-based approach where budesonide/formoterol is used both as daily maintenance therapy AND as-needed reliever therapy in a single inhaler for patients with uncontrolled persistent asthma, providing superior exacerbation prevention compared to conventional fixed-dose regimens while using less total medication. 1
What is SMART Therapy?
SMART represents a paradigm shift in asthma management where patients use the same budesonide/formoterol inhaler for:
- Regular maintenance dosing (typically 2 inhalations twice daily) 2
- Additional as-needed relief when breakthrough symptoms occur 1
This approach delivers additional inhaled corticosteroid with each reliever inhalation, providing immediate anti-inflammatory medication in response to worsening symptoms 1.
Evidence for SMART in Asthma
Efficacy Outcomes
SMART therapy significantly reduces severe asthma exacerbations compared to conventional regimens using short-acting beta2-agonists as reliever therapy, while providing similar or better daily asthma control than higher fixed maintenance doses 1.
Key benefits include:
- 40% reduction in mild exacerbations and 29% reduction in severe exacerbations compared to fixed-dose ICS alone 3
- Improved asthma control with fewer exacerbations compared to fixed-dose fluticasone/salmeterol 4, 1
- Lower mean daily inhaled corticosteroid dose while maintaining superior efficacy 1
- Reduced reliever medication use compared to conventional regimens 5
Practical Advantages
- Single inhaler convenience simplifies treatment and may improve adherence 6, 1
- Immediate step-up therapy when symptoms worsen, with automatic step-down when symptoms resolve 1
- Fast onset of action from formoterol provides immediate symptom relief 6
- Lower total drug exposure (24% fewer inhalations) compared to fixed dosing while maintaining control 7
Current Guideline Recommendations
NAEPP Guidelines (2020)
The National Asthma Education and Prevention Program recommends SMART for:
- Steps 3 and 4 in children and adults with asthma 3
- Patients ≥12 years old as preferred reliever therapy instead of SABA 3
Critical requirement: Formoterol must be used (not salmeterol) due to its rapid onset of action 3.
Important Limitations
SMART is currently off-label use in the United States, as FDA labeling does not include this indication 3, 2. The FDA-approved indication is for maintenance therapy only, with 2 inhalations twice daily 2.
Studies were predominantly performed with budesonide/formoterol specifically; other ICS/formoterol combinations have not been adequately studied for SMART 3.
SMART is NOT Approved for COPD
Symbicort 160/4.5 is FDA-approved only for maintenance treatment of COPD (2 inhalations twice daily), NOT for SMART therapy 2.
For COPD:
- Only the 160/4.5 strength is indicated 2
- Used for maintenance treatment of airflow obstruction and reducing exacerbations 2
- Should NOT be used as reliever therapy in COPD 2
- ICS in COPD should be reserved for patients with ≥2 moderate or ≥1 severe exacerbation per year despite appropriate bronchodilator therapy 8
Practical Implementation Algorithm
Patient Selection for SMART (Asthma Only)
Appropriate candidates:
- Age ≥12 years (some guidelines suggest ≥6 years) 3, 2
- Persistent asthma not adequately controlled on ICS alone 2
- Patients at steps 3-4 of asthma management 3
- Willing to use single inhaler for both maintenance and relief 1
Exclude if:
- Age <6 years 2
- Well-controlled on current low-dose ICS 2
- COPD diagnosis (not indicated) 2
- Need for acute bronchospasm relief (not for acute symptoms) 2
Dosing Strategy
Maintenance dosing:
- Adults/adolescents ≥12 years: 2 inhalations twice daily (morning and evening, 12 hours apart) 2
- Use 80/4.5 or 160/4.5 strength based on asthma severity 2
Reliever dosing (SMART - off-label):
- Additional inhalations as needed for breakthrough symptoms 1
- Maximum studied: up to 8-10 puffs per day total 3
- Patients should rinse mouth after each use 2
Adjustable Maintenance Dosing Alternative
For patients on fixed maintenance therapy, adjustable dosing allows:
- Step-up: Increase to 4 inhalations twice daily for maximum 14 days when asthma worsens 7
- Step-down: Reduce to 2 inhalations once daily or 1 inhalation twice daily when well-controlled 7
- This approach uses 24% less medication than fixed dosing with similar exacerbation rates 7
Critical Safety Considerations
Contraindications and Warnings
Do not use Symbicort for:
- Acute relief of bronchospasm (not a rescue inhaler in conventional use) 2
- Primary treatment of status asthmaticus 2
- Patients allergic to budesonide or formoterol 2
Black box warning: LABAs like formoterol increase risk of asthma-related death when used without ICS 2. However, this risk is mitigated when LABA is combined with ICS in the same inhaler 2.
Common Pitfalls to Avoid
- Never use additional LABA (like salmeterol) when on Symbicort 2
- Do not exceed recommended dosing: More than 2 inhalations twice daily increases adverse effects without additional benefit in fixed dosing 2
- Must prime inhaler: 2 test sprays before first use and if not used for >7 days 2
- Monitor for pneumonia risk in COPD patients (increased with ICS use) 8
- Ensure proper inhaler technique: Critical for drug delivery 2
Monitoring Parameters
- Asthma control: Symptoms, nighttime awakenings, rescue medication use 1
- Exacerbation frequency: Primary outcome measure 1
- Lung function: Peak flow or FEV1 monitoring 5
- Adverse effects: Oral candidiasis, hoarseness, tremor 2
- Inhaler counter: Replace when counter shows "0" or after 3 months from opening foil pouch 2
Cost-Effectiveness
SMART therapy demonstrates: