What are the recommendations for Single Inhaler Maintenance and Reliever Therapy (SMART) in children with asthma, considering different age groups?

SMART Therapy Recommendations in Children with Asthma by Age Group

For children aged 5 years and older with moderate to severe persistent asthma (Steps 3-4), ICS-formoterol as single maintenance and reliever therapy (SMART) is the preferred treatment approach, with age-appropriate ICS dosing in the formulation. 1

Age-Specific Recommendations

Children Under 5 Years Old

• SMART is NOT recommended for this age group 1
• No evidence supports the use of ICS-formoterol as maintenance and reliever therapy in children under 5 years 1
• Standard treatment remains low-dose inhaled corticosteroids via nebulizer, dry powder inhaler, or metered-dose inhaler with holding chamber/face mask 2
• Alternative therapies include leukotriene receptor antagonists (montelukast) or cromolyn 2

Children Aged 5-11 Years

• ICS-formoterol as SMART is recommended at Steps 3 and 4 for moderate to severe persistent asthma 1
• This represents a conditional recommendation with moderate certainty of evidence for this age group 1
• The typical regimen uses budesonide-formoterol 160/4.5 μg (delivered dose), one inhalation once or twice daily for maintenance, plus additional inhalations as needed for symptom relief 3
• Maximum total daily dose should not exceed 12 inhalations in any single day 3
• Important caveat: The NAEPP guidelines differ from GINA guidelines, which do not endorse SMART for children aged 5-11 years 1

Children Aged 12 Years and Older (Adolescents)

• ICS-formoterol as SMART is strongly recommended at Steps 3 and 4 1
• This is a strong recommendation with high certainty of evidence 1
• SMART is preferred over:
  • Higher-dose ICS as daily controller with SABA for quick relief 1
  • Same-dose ICS-LABA as daily controller with SABA for quick relief 1
• For Step 3: One inhalation of budesonide-formoterol 160/4.5 μg once or twice daily for maintenance 3
• For Step 4: Two inhalations of budesonide-formoterol 160/4.5 μg twice daily for maintenance 3
• Additional inhalations taken as needed for symptom relief, up to 12 total inhalations per day 3

Key Clinical Considerations

Medication Selection

• Only budesonide-formoterol and beclometasone-formoterol have been validated for SMART 3, 4
• Other ICS-LABA combinations have not been studied for this indication and should not be used as SMART 3
• The formoterol component is essential because it provides rapid onset of action (similar to SABA) while also being long-acting 3, 4

Implementation Strategy

• Introduce SMART with careful explanation of the dual role: daily maintenance AND symptom relief 3
• Provide a customized written asthma action plan that clearly explains when to use the inhaler for maintenance versus relief 3
• Emphasize that patients should NOT use a separate SABA inhaler when on SMART therapy 3
• Check inhaler technique at every visit, as poor technique undermines treatment efficacy 5

Advantages of SMART Over Traditional Fixed-Dose Therapy

• Reduces exacerbations requiring oral corticosteroids: 2 fewer patients per 100 treated over 8 months need oral steroids 6
• Reduces hospitalizations and emergency room visits: 1 fewer patient per 100 treated over 8 months requires hospitalization or ER visit 6
• Achieves these benefits with lower overall ICS exposure compared to higher fixed-dose combination therapy 6, 3
• Provides flexibility to increase ICS dose only when needed during symptom worsening 6

Common Pitfalls and How to Avoid Them

Pitfall 1: Using SMART in Children Under 5 Years

• Avoid this entirely - no evidence supports safety or efficacy in this age group 1
• Stick to conventional low-dose ICS with separate SABA reliever for young children 2

Pitfall 2: Combining SMART with Additional LABA

• Never prescribe SMART alongside another LABA-containing medication due to risk of overdose 7
• Ensure patients discontinue any separate LABA therapy when starting SMART 7

Pitfall 3: Using Non-Formoterol ICS-LABA Combinations

• Do not use salmeterol-containing combinations for SMART 3, 4
• Salmeterol has slower onset of action and has not been studied for reliever use 3
• Only formoterol-containing combinations are appropriate 3, 4

Pitfall 4: Inadequate Patient Education

• Patients may continue using SABA alongside SMART, resulting in excessive beta-agonist exposure 3
• Clearly instruct patients to use ONLY the ICS-formoterol inhaler for both maintenance and relief 3
• Provide written instructions and demonstrate proper technique 3

Pitfall 5: Prescribing SMART for Mild Persistent Asthma (Step 1-2)

• SMART is indicated only for Steps 3 and 4 therapy 1
• For mild persistent asthma in adolescents ≥12 years, consider as-needed ICS-formoterol OR daily low-dose ICS with as-needed SABA instead 1

Monitoring and Follow-Up

Initial Assessment (4-6 Weeks)

• Evaluate response to therapy within 4-6 weeks of initiation 2
• Assess symptom control, exacerbation frequency, and adherence 2
• Review inhaler technique to ensure proper use 5

Ongoing Management

• Monitor for signs of asthma control at each visit 1
• Track total daily inhaler use - frequent reliever use (>2 inhalations/day beyond maintenance dose) indicates poor control 3
• Consider step-down therapy once control is sustained for at least 3 months 2
• Do NOT increase ICS dose during exacerbations in adherent patients - the SMART regimen already provides increased ICS with increased reliever use 1

Safety Monitoring

• Assess for oral candidiasis and advise mouth rinsing after each use 7
• Monitor growth in pediatric patients on long-term ICS therapy 1, 7
• Watch for cardiovascular effects from beta-agonist component, though these are rare at therapeutic doses 7