Asthma treatment guidelines
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asthma treatment guidelines 2025 GINA stepwise therapy
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PMID: 41005695
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Asthma Treatment Guidelines (GINA 2025 / NAEPP)
Overview
Both the Global Initiative for Asthma (GINA) and the National Asthma Education and Prevention Program (NAEPP) use a stepwise approach to asthma management, titrating therapy up or down based on symptom control and exacerbation risk. The cornerstone is inhaled corticosteroid (ICS)-containing therapy for all patients - SABA-only therapy is no longer recommended at any step.
Goals of Treatment
- Achieve symptom control with the least medication and fewest side effects
- Minimize risk of exacerbations, fixed airflow limitation, and medication adverse effects
- Enable normal activity and lung function
- Assessment includes: impairment (symptom frequency, lung function) and risk (exacerbation frequency/severity)
Before stepping up therapy, always address:
- Adherence to medications
- Inhaler technique (identified as the cause of poor control in up to 50% of referred patients)
- Comorbidities (rhinitis, GERD, obesity, OSA)
- Allergen/trigger exposure
GINA 2025 Stepwise Approach (Adults & Adolescents ≥12 years)
GINA now offers two preferred treatment tracks:
Track 1 (Preferred) - Anti-Inflammatory Reliever (AIR) Approach
| Step | Preferred Controller | Reliever |
|---|---|---|
| Step 1 | As-needed low-dose ICS-formoterol | As-needed ICS-formoterol |
| Step 2 | As-needed low-dose ICS-formoterol | As-needed ICS-formoterol |
| Step 3 | Low-dose ICS-LABA maintenance | As-needed low-dose ICS-formoterol |
| Step 4 | Medium-dose ICS-LABA maintenance | As-needed low-dose ICS-formoterol |
| Step 5 | High-dose ICS-LABA ± add-on therapy | As-needed low-dose ICS-formoterol |
At Steps 3-5, the MART regimen (Maintenance and Reliever Therapy) uses ICS-formoterol as both maintenance and as-needed relief.
Track 2 - Traditional Fixed-Dose Approach
| Step | Preferred Controller | Reliever |
|---|---|---|
| Step 1 | Low-dose ICS taken whenever SABA used | As-needed SABA |
| Step 2 | Daily low-dose ICS | As-needed SABA |
| Step 3 | Low-dose ICS-LABA | As-needed SABA |
| Step 4 | Medium-dose ICS-LABA | As-needed SABA |
| Step 5 | High-dose ICS-LABA ± add-on therapy | As-needed SABA |
Source: Murray & Nadel's Textbook of Respiratory Medicine, Table 62.3
Step-Up / Step-Down Principles
- Step up when asthma is uncontrolled at current therapy (after confirming adherence/technique)
- Step down after 3 months of well-controlled asthma - use lowest effective dose
- Reassess control every 2-3 months
- Follow-up within 1-4 weeks after any treatment change
Pediatric-Specific Guidance (NAEPP 2020 Focused Updates)
| Age group | Key guidance |
|---|---|
| 0-4 years (intermittent/URI-triggered) | Short course ICS + SABA at onset of viral infection |
| 5-11 years (Steps 3-4) | SMART therapy: single ICS-formoterol inhaler used both daily and as-needed |
| ≥12 years (Steps 3-4) | SMART therapy preferred; LAMA add-on at Step 3+ |
| ≥5 years (Steps 2-4) | Subcutaneous allergen immunotherapy if sensitized |
Source: Harriet Lane Handbook, 23rd ed., Chapter 25
Add-On Therapies for Severe Asthma (Step 5)
Before starting biologics, confirm:
- High-dose ICS-LABA is being taken with good adherence/technique
- Comorbidities are treated (rhinitis, GERD, obesity)
- Asthma phenotyping/endotyping has been done
Biologic Agents
| Drug | Target | Indication |
|---|---|---|
| Omalizumab | Anti-IgE | Allergic asthma, ≥5 years |
| Mepolizumab / Reslizumab | Anti-IL-5 | Eosinophilic asthma |
| Benralizumab | Anti-IL-5Rα | Eosinophilic asthma |
| Dupilumab | Anti-IL-4Rα (IL-4/IL-13) | Type 2 asthma, ≥12 years |
| Tezepelumab | Anti-TSLP | Severe uncontrolled asthma (broad phenotype) |
A 2026 ACCP systematic review (PMID: 41005695) notes that biologic selection depends on quality of life impairment, baseline FEV1, exacerbation frequency, baseline OCS use, endotype, and biomarkers (blood eosinophils, IgE, FeNO). Head-to-head comparisons remain limited.
Other Step 5 Options
- LAMA (tiotropium): Add-on for uncontrolled asthma on medium-high ICS-LABA; improves lung function and reduces exacerbations
- Low-dose azithromycin (250-500 mg three times/week x 26-48 weeks): For persistent symptomatic asthma at Step 5, particularly non-eosinophilic or neutrophilic phenotype
- Low-dose oral corticosteroids: Last resort; weigh significant side-effect burden
- Leukotriene receptor antagonists (LTRA): Add-on option at multiple steps, especially with comorbid allergic rhinitis
Source: Harrison's Principles of Internal Medicine, 22nd ed., Table 298-5
Biomarkers in Asthma Management
| Biomarker | Use |
|---|---|
| Blood eosinophils | Predict response to anti-IL-5 biologics; ≥300/µL suggests Type 2 |
| Total IgE | Guides omalizumab dosing |
| FeNO | Adjunct diagnostic aid ≥5 years; high values (>50 ppb) predict steroid response |
| Periostin | Emerging marker for IL-13-driven inflammation |
Key 2025 Updates vs. Older Guidelines
- No SABA monotherapy - ICS must accompany all reliever use
- AIR (Anti-Inflammatory Reliever) concept - as-needed ICS-formoterol is safe and effective even at Step 1
- Severe asthma biologics - Type 2 biologics are now standard of care before escalating to oral steroids
- ICS-SABA combination inhaler - GINA now recognizes ICS/albuterol combination as an alternative anti-inflammatory reliever in the US
- Bronchial thermoplasty - No longer routinely recommended (manufacturer discontinued devices)
Acute Exacerbation Management (Brief)
- Mild-moderate: Repeat doses of SABA (or ICS-formoterol on Track 1), oral corticosteroids if not improving
- Severe/status asthmaticus: IV/IM corticosteroids, continuous nebulized SABA, ipratropium, supplemental O2 (target SpO2 93-95%), consider IV magnesium sulfate, escalate to ICU if needed
- Intensification of controller therapy for 3-10 days after exacerbation
Key sources: Harrison's Principles of Internal Medicine 22E (2025) | Murray & Nadel's Textbook of Respiratory Medicine | Harriet Lane Handbook 23rd ed. | ACCP Biologic Guidelines 2026 (PMID: 41005695)
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