Do the 2025 Global Initiative for Asthma (GINA) guidelines recommend formoterol for children under 4 years?

Formoterol Not Recommended for Children Under 4 Years of Age

The 2025 GINA guidelines do not recommend formoterol for children under 4 years of age, as it is listed as "not available/not approved" for this age group. 1

Evidence Supporting Non-Use in Children Under 4

• The Global Initiative for Asthma (GINA) guidelines clearly indicate that formoterol is not approved or recommended for children under 4 years of age 1
• Expert Panel Report guidelines similarly designate formoterol delivered via dry powder inhaler (DPI) as "NA" (not available/not approved) for the 0-4 years age group, indicating insufficient safety and efficacy data in this population 1
• Treatment recommendations for asthma are specifically divided by age groups, with children under 5 years being treated differently due to:
  • Inability of young children to provide adequate lung function data 1
  • Paucity of well-controlled clinical trials in very young children 1
  • Different response patterns to therapy in young children with predominantly virus-induced wheezing 1

Physiological Considerations

• Children under 4 years face specific challenges with formoterol use:
  • Lower tidal volumes result in reduced aerosol delivery when using face masks 1
  • Most children under 4 years cannot generate sufficient inspiratory flow required for dry powder inhalers, which is how formoterol is commonly delivered 1
  • Developmental differences in drug metabolism may affect safety and efficacy profiles 1

Recommended Alternatives for Young Children

• For children 0-4 years with recurrent wheezing triggered by respiratory infections, guidelines recommend:
  • Short courses of inhaled corticosteroids (ICS) at the onset of respiratory illness 2, 1
  • As-needed short-acting beta-agonists (SABA) for quick relief 1
• The 2020 focused updates to asthma management guidelines address treatment for 0-4 year olds but do not include formoterol as a recommended option 1

Important Clinical Considerations

• Attempting to use medications approved for older children in very young children without sufficient evidence poses safety risks 1
• GINA guidelines for older children (6-11 years) do include formoterol-containing therapies, but these recommendations do not extend to the under-4 age group 3
• The 2024 GINA update continues to emphasize age-appropriate treatment strategies, with formoterol recommendations starting only from older age groups 4

Safety Data

• While safety studies of formoterol have been conducted in children and adolescents aged 4-17 years 5, there is insufficient safety data specifically for children under 4 years
• The physiological differences in very young children require specific evidence before recommending formoterol use in this vulnerable population 1