Track 1 Step 3 Inhaler for Daily Use
For step 3 asthma therapy using the maintenance-and-reliever (SMART) track, prescribe budesonide-formoterol 160/4.5 μg (or beclomethasone-formoterol equivalent), one inhalation twice daily for maintenance, with additional inhalations of the same inhaler as needed for symptom relief, up to 12 total inhalations per day. 1
Understanding the Two Treatment Tracks
Modern asthma guidelines define two distinct therapeutic approaches for step 3 therapy:
- Track 1 (SMART/MART approach): Uses a single ICS-formoterol inhaler for both daily maintenance AND as-needed relief 1, 2
- Track 2 (Fixed-dose approach): Uses separate inhalers for maintenance (ICS-LABA) and relief (SABA alone) 2
The SMART strategy is equally recommended alongside fixed-dose therapy, with the choice depending on patient-specific risk factors and physician judgment. 2
Specific Step 3 SMART Regimen
Daily Maintenance Dosing
- Adults and adolescents ≥12 years: Budesonide-formoterol 160/4.5 μg, one inhalation twice daily 1
- Children 4-11 years: Data for SMART in this age group is limited; most clinical trials enrolled patients ≥12 years 1
As-Needed Relief Dosing
- Take one additional inhalation of budesonide-formoterol 160/4.5 μg whenever symptoms occur 1
- Maximum daily limit: 12 total inhalations in any 24-hour period (delivering 54 μg formoterol total) 1
- This provides both immediate bronchodilation AND anti-inflammatory coverage with each rescue use 1
Critical Medication Specifications
Only specific ICS-formoterol combinations are validated for SMART:
Do NOT use for SMART:
- Fluticasone-salmeterol (salmeterol does not provide rapid relief) 3, 1
- Fluticasone-vilanterol (vilanterol is not a rapid-onset LABA) 4
- Any ICS-LABA combination other than formoterol-containing products 1
Why SMART Works Better Than Traditional Approaches
The SMART strategy provides superior outcomes compared to fixed-dose therapy because:
- Reduced exacerbation risk: Each as-needed dose delivers anti-inflammatory medication precisely when airway inflammation is worsening 1
- Lower overall ICS exposure: Patients use ICS only when needed for symptoms, rather than taking high fixed doses continuously 1
- Rapid symptom relief: Formoterol provides bronchodilation as quickly as albuterol 1
Common Prescribing Errors to Avoid
Wrong Inhaler Selection
- 11-14% of allergists incorrectly prescribe ICS-salmeterol for SMART 4
- Salmeterol has slow onset (15-30 minutes) and cannot serve as rescue therapy 3
- Only formoterol-containing inhalers work for SMART 1
Wrong Dosing Strategy
- Only 6% of physicians prescribe the guideline-recommended very-low to low-dose ICS-formoterol for step 3 SMART in children 4
- Most prescribe higher doses than necessary 4
- Start with the lowest effective dose: budesonide-formoterol 160/4.5 μg twice daily 1
Insurance Coverage Issues
- Incomplete insurance coverage is the #1 barrier to implementing SMART 4
- Many insurers approve only one canister per month, which is insufficient for SMART (patients need maintenance doses PLUS as-needed doses) 4
- Proactively address prior authorization requirements and document medical necessity 4
Patient Education Essentials
Provide a written asthma action plan that clearly explains:
- Take one inhalation twice daily every day, even when feeling well 1
- Take additional inhalations (same inhaler) whenever symptoms occur 1
- Maximum 12 total inhalations in 24 hours 1
- Do NOT use a separate albuterol inhaler - the budesonide-formoterol serves both purposes 1
When SMART May Not Be Appropriate
Consider fixed-dose therapy (Track 2) instead if:
- Patient cannot understand the dual-use concept (maintenance + relief from same inhaler) 1
- Insurance will not cover adequate supply 4
- Formoterol-containing products are unavailable or unaffordable 1
Alternative Step 3 Options (Track 2)
If SMART is not feasible, prescribe:
- Fluticasone-salmeterol 250/50 μg, one inhalation twice daily (for patients ≥12 years) 3
- Plus separate albuterol inhaler for as-needed relief 3
This fixed-dose approach is effective but does not provide the anti-inflammatory benefit with each rescue dose that SMART delivers 1.