First-Line Treatment for Pediatric Asthma
Low-dose inhaled corticosteroids (ICS) are the preferred first-line controller therapy for children with persistent asthma across all pediatric age groups. 1, 2, 3, 4
Treatment Algorithm by Age
Infants and Children Under 5 Years
Preferred delivery method: Budesonide nebulizer solution (FDA-approved for ages 1-8 years) OR fluticasone via dry powder inhaler (DPI) for children ≥4 years OR any ICS via metered-dose inhaler (MDI) with spacer/holding chamber with or without face mask 1, 2, 5
Alternative options (when ICS cannot be used): Leukotriene receptor antagonist (montelukast 4 mg chewable tablet, FDA-approved for ages ≥2 years) OR cromolyn via nebulizer 1, 2
Important caveat: Cromolyn has inconsistently demonstrated symptom control in children <5 years and insufficient evidence exists for meaningful effect 1
School-Age Children (5-11 Years)
Alternative options: Leukotriene receptor antagonists (montelukast) OR cromolyn OR nedocromil 1, 4
Evidence strength: The PACT trial demonstrated that fluticasone monotherapy gained 42 additional asthma control days per year compared to montelukast (number needed to treat = 6.5), establishing ICS superiority 1, 4
Adolescents (≥12 Years)
Preferred: Daily low-dose ICS with as-needed short-acting beta-agonist (SABA) 2
Alternative: As-needed ICS and SABA used concomitantly 2
When to Initiate Controller Therapy
Initiate daily long-term controller therapy when ANY of the following criteria are met:
- Symptoms requiring treatment >2 times per week 1, 3
- Severe exacerbations requiring beta-agonist more frequently than every 4 hours over 24 hours, occurring <6 weeks apart 1
- High-risk infants/young children: >3 wheezing episodes in past year lasting >1 day AND affecting sleep PLUS either (a) parental history of asthma OR physician-diagnosed atopic dermatitis, OR (b) two of: physician-diagnosed allergic rhinitis, >4% peripheral blood eosinophilia, or wheezing apart from colds 1, 2
Step-Up Therapy for Inadequate Control
Moderate Persistent Asthma
- Preferred option 1: Low-dose ICS + long-acting beta-agonist (LABA) - salmeterol DPI FDA-approved for ages ≥4 years 1, 2
- Preferred option 2: Medium-dose ICS monotherapy 1, 2
- Alternative: Low-dose ICS + leukotriene receptor antagonist OR theophylline (with serum monitoring) 1, 2
Critical Safety Point
Never use LABAs as monotherapy - they must always be combined with ICS 2, 4
Monitoring and Adjustment
- Assessment timeline: Evaluate response within 4-6 weeks of initiating therapy 1, 2, 3
- If no clear benefit: Consider alternative therapies or diagnoses 1, 2, 3
- Once control established: Attempt careful step-down in therapy 1, 2
Delivery Device Selection
- Children <4 years unable to coordinate: Nebulizer is preferred for passive inhalation 5, 6
- All MDI users: Always use large-volume spacer device to enhance lung deposition and reduce oral side effects 4
- Before stepping up therapy: Verify age-appropriate device selection and proper inhaler technique 4
Safety Profile of ICS
- Growth effects: Clinical trials following children up to 6 years show no long-term, clinically significant, or irreversible effects on vertical growth, bone mineral density, ocular toxicity, or adrenal/pituitary axis suppression at recommended doses 2, 3, 7
- Growth monitoring: The PACT trial showed no statistical difference in growth over 48 weeks between fluticasone (5.3 cm), fluticasone/salmeterol (5.3 cm), and montelukast (5.7 cm) 1, 4
- Dose optimization: Titrate to lowest effective dose to maintain control while minimizing potential side effects 2, 7
- Oral candidiasis prevention: Rinse mouth with water after ICS inhalation; use spacer devices with all MDI-delivered ICS 4
Common Pitfalls to Avoid
- Underdiagnosis in young children: Asthma is frequently mislabeled as "chronic bronchitis," "wheezy bronchitis," or "recurrent pneumonia" 1
- Not all wheezing is asthma: Viral respiratory infections are the most common cause of wheezing in preschool-aged children; consider alternative diagnoses like gastroesophageal reflux, cystic fibrosis, or chronic lung disease of prematurity 1, 4
- Theophylline in young children: Not recommended as alternative for mild persistent asthma due to particular risks with febrile illnesses that increase theophylline concentrations 1
Comparative Efficacy Evidence
The CLIC and PACT trials provide definitive evidence that ICS are superior to leukotriene receptor antagonists: 1
- ICS improved asthma control days, pulmonary function (FEV1/FVC, PEF), and inflammatory biomarkers (exhaled nitric oxide) significantly more than montelukast 1
- Greater differential response to ICS over montelukast was associated with higher bronchodilator use, bronchodilator response, exhaled nitric oxide levels, and eosinophil cationic protein levels 1