What are the recommendations for managing asthma according to the new Global Initiative for Asthma (GINA) guidelines?

New GINA Guidelines for Asthma Management

All adults and adolescents with asthma should receive inhaled corticosteroid (ICS)-containing therapy—never SABA alone—with low-dose ICS-formoterol as the preferred reliever medication at all treatment steps to prevent severe exacerbations and asthma-related deaths. 1, 2

Core Paradigm Shift from Previous Guidelines

The most fundamental change in GINA is the complete abandonment of SABA-only treatment for any severity of asthma, including intermittent disease. 1, 3, 4 This represents a safety-driven revolution based on evidence that:

• SABA-only treatment increases risk of severe exacerbations and asthma-related deaths 3
• As-needed low-dose ICS-formoterol reduces severe exacerbations by ≥60% compared with SABA alone in mild asthma 1, 4
• LABAs must NEVER be used as monotherapy due to increased asthma-related death risk 1, 2

Two-Track Treatment Approach

GINA 2021 introduced two distinct treatment tracks for adults and adolescents: 4

Track 1 (Preferred):

• Low-dose ICS-formoterol as reliever at ALL steps 1, 4
• Steps 1-2: As-needed ICS-formoterol only (for mild asthma) 4
• Steps 3-5: Daily maintenance ICS-formoterol PLUS as-needed ICS-formoterol (SMART/MART therapy) 1, 2, 4

Track 2 (Alternative):

• As-needed SABA across all steps 4
• Step 2: Regular low-dose ICS 4
• Steps 3-5: ICS-LABA combination 4

Critical caveat: Formoterol is the only LABA suitable for as-needed use due to rapid onset; salmeterol should never be used for SMART therapy. 2

Assessment Framework: Control Over Severity

GINA emphasizes asthma control (current state, modifiable by treatment) rather than severity (intrinsic disease intensity) for ongoing management. 1, 5, 6

Two Domains of Control Assessment:

1. Current Impairment: 1, 2

• Daytime symptoms ≤2 days/week
• No nighttime awakenings
• Reliever use ≤2 days/week
• No activity limitation
• Normal lung function (FEV₁ or PEF)

2. Future Risk: 1, 5

• Frequency of exacerbations requiring oral corticosteroids
• Progressive lung function decline
• Medication side effects

Well-controlled asthma requires ALL impairment criteria met over past 4 weeks. 1, 2 Meeting 1-2 criteria = partly controlled; meeting 3-4 criteria = uncontrolled. 2

Stepwise Treatment Algorithm (6 Steps)

The expansion from 4 to 6 steps allows simplified actions within each step: 7, 4

Step 1: As-needed low-dose ICS-formoterol (preferred) 1, 4

Step 2: Daily low-dose ICS OR as-needed low-dose ICS-formoterol 4

Step 3: Low-dose ICS-LABA maintenance + as-needed ICS-formoterol (SMART) 4

Step 4: Medium-dose ICS-LABA maintenance + as-needed ICS-formoterol (SMART) 4

Step 5: High-dose ICS-LABA + as-needed ICS-formoterol, consider add-on LAMA, azithromycin, or biologics 4

Step 6: High-dose ICS-LABA + oral corticosteroids + biologics 7

Treatment Adjustment Rules:

• Step up if partly controlled, uncontrolled, or ≥2 exacerbations requiring oral corticosteroids in past year 2
• Step down when well-controlled for ≥3 months 1, 2
• Before stepping up: verify adherence, inhaler technique, and environmental control 7, 1

Diagnosis Requirements

Asthma diagnosis requires compatible clinical history PLUS objective confirmation of variable expiratory airflow limitation: 1, 5

Five Methods for Objective Confirmation: 5

1. Positive bronchodilator responsiveness (FEV₁ increase ≥12% and ≥200mL)
2. Excessive variability in twice-daily PEF (>10% in adults)
3. Increase in lung function after 4 weeks of ICS treatment
4. Positive bronchial challenge test
5. Excessive variation in lung function between visits

Key indicators: Wheezing, recurrent cough, difficulty breathing, chest tightness worsening with triggers (exercise, allergens, cold air, viral infections). 7

Acute Exacerbation Management

Life-Threatening Features (Immediate ICU consideration): 1, 2

• PEF <33% predicted/best
• Silent chest, cyanosis, feeble respiratory effort
• Bradycardia, hypotension
• Confusion, exhaustion, coma

Severe Features: 1, 2

• Inability to complete sentences in one breath
• Respiratory rate >25/min
• Heart rate >110/min
• PEF <50% predicted/best

Immediate Treatment Protocol: 1, 2

1. High-flow oxygen 40-60% simultaneously with:
2. Nebulized salbutamol 5mg or terbutaline 10mg (oxygen-driven)
3. Systemic corticosteroids (prednisolone 30-60mg PO or hydrocortisone 200mg IV)
4. Add ipratropium bromide 0.5mg for life-threatening features 7, 1

Hospital admission criteria: Any life-threatening features, severe features persisting after initial treatment, or PEF <33% after treatment. 5

Important: GINA no longer recommends doubling ICS dose for home management of exacerbations—this strategy is ineffective. 2

Essential Self-Management Components

Every patient must receive: 1, 2, 5

• Written asthma action plan with specific PEF or symptom thresholds for medication adjustment
• Inhaler technique training (verified at every visit)
• Clear understanding of "relievers" versus "preventers"
• Personal peak flow meter for monitoring

Special Populations

Children 6-11 Years: 1, 2

• Do NOT use SMART therapy (not recommended in this age group)
• Use lowest ICS dose providing acceptable control
• ICS doses >400 µg/day cause short-term reductions in tibial growth rate 1, 2
• New treatment options added at Steps 3-4 in GINA 2021 1, 4

Children 0-5 Years: 2

• GINA does not recommend ICS-formoterol as reliever therapy
• Diagnosis relies on symptoms rather than objective testing 2

Pregnant Women: 1, 5

• Refer for specialist consultation if asthma worsens

Modifiable Risk Factors to Address

Common factors increasing exacerbation risk: 1, 5

• Allergen exposure (dust mites, animal dander, pollens)
• Environmental tobacco smoke
• Air pollution
• Poor medication adherence
• Incorrect inhaler technique
• Obesity
• Comorbidities (rhinosinusitis, GERD, obstructive sleep apnea)

Annual influenza vaccination recommended for all patients with persistent asthma. 1, 5

When to Refer to Specialist

Refer when: 2

• Difficulty achieving or maintaining control
• ≥2 bursts of oral corticosteroids in past year
• Any exacerbation requiring hospitalization
• Considering biologic therapy

Key Differences from NAEPP Guidelines

GINA differs from US NAEPP guidelines: 2

• GINA recommends ICS-formoterol for intermittent asthma in adults; NAEPP does not
• GINA recommends SMART through Step 5; NAEPP only at Steps 3-4
• GINA functions as an asthma strategy rather than rigid guideline, emphasizing adaptation to local healthcare systems 5

ICS Safety Considerations

• Doses >500 µg/day carry significant systemic adverse effects including adrenal suppression equivalent to 5mg oral prednisone daily 2
• Use lowest dose providing acceptable control 1, 2
• In children, doses >400 µg/day cause short-term reductions in tibial growth rate 2