What is the treatment approach for asthma according to the Global Initiative for Asthma (GINA) classification?

Asthma Treatment According to GINA Classification

GINA organizes asthma treatment into a 5-step framework based on control assessment rather than severity, with inhaled corticosteroid-formoterol (ICS-formoterol) as the preferred reliever at all steps, escalating from as-needed use in mild asthma to maintenance-and-reliever therapy (MART) in moderate-to-severe disease. 1, 2

Control-Based Classification System

GINA classifies asthma into three control levels—controlled, partly controlled, and uncontrolled—rather than focusing on severity categories. 1, 3 This control assessment evaluates two distinct domains:

Symptom Control Domain (assessed over past 4 weeks): 1, 4

• Daytime symptoms ≤2 days/week
• No nighttime awakenings due to asthma
• Reliever use ≤2 days/week
• No activity limitation due to asthma
• Lung function (FEV₁ or PEF) >80% predicted/personal best 5

Future Risk Domain: 1, 5

• Exacerbation history (particularly those requiring oral corticosteroids)
• Risk factors for fixed airflow limitation (lack of ICS treatment, tobacco smoke exposure, chronic mucus hypersecretion)
• Risk factors for medication side effects

Patients are classified as controlled if all symptom criteria are met, partly controlled if 1-2 criteria are not met, and uncontrolled if 3-4 criteria are not met. 5, 1

The 5-Step Treatment Framework

GINA 2021 divides treatment into two tracks, with Track 1 (preferred) using ICS-formoterol as reliever throughout: 2, 1

Track 1 (Preferred Approach)

Step 1 (Mild Intermittent): 2, 6

• As-needed low-dose ICS-formoterol only
• No daily controller medication
• This replaces the outdated SABA-only approach due to risks of SABA overuse and evidence showing ICS-formoterol reduces severe exacerbations by ≥60% compared with SABA alone 2

Step 2 (Mild Persistent): 2, 1

• As-needed low-dose ICS-formoterol
• Consider daily low-dose ICS if symptoms occur ≥2 times/week

Step 3 (Moderate Persistent): 2, 6

• Daily low-dose ICS-formoterol PLUS as-needed low-dose ICS-formoterol (MART therapy)
• This maintenance-and-reliever approach provides both baseline control and rapid symptom relief

Step 4 (Moderate-to-Severe Persistent): 2, 6

• Daily medium-dose ICS-formoterol PLUS as-needed low-dose ICS-formoterol (MART)
• Alternative: High-dose ICS-LABA combination

Step 5 (Severe Persistent): 2, 1

• High-dose ICS-formoterol PLUS as-needed ICS-formoterol
• Add-on therapies in sequence: 2, 4
  • Long-acting muscarinic antagonist (LAMA) first
  • Azithromycin (for patients with persistent exacerbations)
  • Phenotype-specific biologic therapies (anti-IgE, anti-IL5, anti-IL4R)
  • Oral corticosteroids only if all other options exhausted

Track 2 (Alternative Approach)

Uses as-needed SABA as reliever across all steps, with daily ICS starting at Step 2 and ICS-LABA combinations at Steps 3-5. 2, 1 However, this track is less preferred due to SABA-associated risks. 2

Treatment Adjustment Algorithm

Step Up Treatment When: 5, 6

• Asthma is partly controlled or uncontrolled
• Patient has ≥2 exacerbations requiring oral corticosteroids in past year
• Any life-threatening exacerbation occurs

Before Stepping Up, Verify: 5, 6, 4

• Medication adherence
• Proper inhaler technique (most common cause of treatment failure)
• Environmental trigger control
• Comorbidity management (rhinitis, GERD, obesity, anxiety/depression)

Step Down Treatment When: 1, 6

• Asthma has been well-controlled for ≥3 months
• Goal is to find the lowest effective dose
• Reduce ICS dose by 25-50% every 3 months while maintaining control

Critical Medication Principles

ICS are the cornerstone: 4, 6

• Most effective single long-term controller medication
• Reduce airway inflammation, improve symptoms, lung function, and quality of life
• Should never be omitted, even in mild asthma 2, 7

LABA safety: 4

• Never use as monotherapy (increases risk of asthma-related death)
• Always combine with ICS
• Formoterol has rapid onset, making it suitable for both maintenance and reliever therapy 4

High-dose ICS risks: 4

• Doses >500 mcg/day (beclomethasone equivalent) cause significant systemic effects including adrenal suppression equivalent to 5 mg oral prednisone daily
• In children, doses >400 mcg/day cause short-term reductions in tibial growth rate 4

Pediatric Modifications

Children 6-11 years: 2, 1

• Control criteria adjusted: well-controlled defined as nighttime awakenings ≤1 time/month
• New treatment options added at Steps 3-4 in GINA 2021
• ICS-formoterol approach can be used but with age-appropriate dosing

Children 0-5 years: 1, 4

• Diagnosis relies on symptoms rather than objective testing
• Bronchodilator response is variable
• Treatment approach more conservative with emphasis on ICS monotherapy

Essential Non-Pharmacologic Management

Every patient must receive: 4, 6

• Written asthma action plan with specific PEF or symptom thresholds for medication adjustment
• Inhaler technique training (verify at every visit)
• Clear distinction between "relievers" and "preventers"
• Environmental trigger identification and reduction strategies 4
• Annual influenza vaccination 6

Specialist Referral Indications

Refer to asthma specialist when: 5

• Difficulty achieving or maintaining control
• Patient required ≥2 bursts of oral corticosteroids in 1 year
• Any exacerbation requiring hospitalization
• Step 4 care or higher required (Step 3 or higher for children 0-4 years)
• Considering biologic therapy or allergen immunotherapy

Common Pitfalls to Avoid

Do not: 6, 4

• Ignore exacerbation history when assessing control
• Rely on symptoms alone without lung function assessment
• Assess severity during acute exacerbations
• Continue SABA-only treatment for any patient with asthma 2, 7
• Use LABA without ICS 4
• Assume symptom control equals elimination of exacerbation risk (especially in severe asthma) 4