What are safe asthma controller medications, such as inhaled corticosteroids (ICS), for children 5 years and younger?

Safe Asthma Controller Medications for Children 5 Years and Younger

Low-dose inhaled corticosteroids (ICS) are the preferred and safest controller medication for children 5 years and younger with persistent asthma, with budesonide nebulizer solution FDA-approved from age 1 year and fluticasone dry powder inhaler approved from age 4 years. 1

Primary Controller Options

Inhaled Corticosteroids (First-Line Therapy)

ICS represent the most effective anti-inflammatory treatment and should be the initial controller medication for persistent asthma in young children. 1

• Budesonide nebulizer solution is FDA-approved for children 1-8 years of age and is the preferred formulation for children under 4 years who cannot effectively use other devices 1
• Fluticasone dry powder inhaler (DPI) is FDA-approved for children 4 years and older 1
• Delivery should use either a nebulizer or metered-dose inhaler (MDI) with a valved holding chamber (spacer), with or without a face mask for children under 4 years 1

The benefits of ICS clearly outweigh concerns about potential adverse effects, including the small, nonprogressive reduction in growth velocity. 1

Safety Profile of ICS

• ICS should be titrated to the lowest effective dose needed to maintain asthma control 1
• At low to medium doses, systemic adverse effects are minimal and include primarily local effects (cough, dysphonia, oral thrush) 2, 3
• Growth suppression averages approximately 0.48 cm/year during the first year of treatment but is less pronounced in subsequent years 4
• One long-term study showed a mean reduction of 1.20 cm in adult height with budesonide 400 μg/day used for 4.3 years, but this must be weighed against the morbidity of uncontrolled asthma 4
• Mouth rinsing after each treatment reduces local side effects 1, 2

Alternative Controller Options

Leukotriene Receptor Antagonists (LTRAs)

• Montelukast 4 mg chewable tablet is FDA-approved for children 2-6 years of age (based on safety data rather than efficacy data) 1
• Montelukast has shown some effectiveness in children 2-5 years of age 1
• Consider LTRAs when inhaled medication delivery is suboptimal due to poor technique or adherence issues 1
• LTRAs are listed as alternative (not preferred) therapy because evidence for efficacy is less robust than for ICS 1

Cromolyn Sodium

• Cromolyn is an alternative option but has inconsistently demonstrated symptom control in children younger than 5 years 1
• It is less preferred than ICS or LTRAs due to weaker evidence of effectiveness 1

Medications NOT Recommended for This Age Group

Long-Acting Beta-Agonists (LABAs)

• Salmeterol DPI is FDA-approved only for children 4 years and older 1
• LABAs should never be used as monotherapy and only in combination with ICS for moderate-to-severe asthma 1
• No evidence supports ICS-formoterol as single maintenance and reliever therapy (SMART) in children under 5 years 5

Theophylline

• Sustained-release theophylline is NOT recommended as an alternative controller for young children with mild persistent asthma 1
• Particular risks exist in infants who frequently have febrile illnesses, which increase theophylline concentrations 1
• May only be considered as adjunctive therapy in moderate-to-severe persistent asthma with careful serum concentration monitoring 1

Clinical Decision Algorithm

When to Initiate Controller Therapy

Start daily long-term controller therapy in children 5 years and younger who have: 1

1. Symptoms requiring treatment more than 2 times per week, OR
2. Severe exacerbations requiring beta-agonist more frequently than every 4 hours over 24 hours, occurring less than 6 weeks apart, OR
3. More than 3 episodes of wheezing in the past year lasting more than 1 day AND affecting sleep PLUS risk factors:
   • Parental history of asthma OR physician-diagnosed atopic dermatitis, OR
   • Two of: physician-diagnosed allergic rhinitis, >4% peripheral blood eosinophilia, or wheezing apart from colds 1

Monitoring and Adjustment

• Assess response within 4-6 weeks of initiating therapy 1, 2
• Stop treatment if no clear beneficial effect is obvious within 4-6 weeks and medication technique/adherence are satisfactory 1
• When benefits are sustained for 2-4 months, attempt a step-down in therapy 1
• Consider alternative diagnoses if no response to appropriate therapy 1

Common Pitfalls to Avoid

• Do not overtreat viral-induced wheeze that resolves between episodes - many children who wheeze with viral infections experience remission by age 6 years 1
• Do not use high-dose ICS initially - start with low doses and titrate up only if needed 1, 2
• Do not prescribe LABAs as monotherapy - they must always be combined with ICS 1
• Ensure proper inhaler technique - use face masks that fit snugly over nose and mouth for young children, and verify technique at each visit 1, 2
• Do not continue ineffective therapy - the therapeutic trial approach is essential in this age group where diagnosis can be uncertain 1