Does the Global Initiative for Asthma (GINA) recommend formoterol for children under the age of 4 years?

Formoterol Use in Children Under 4 Years of Age According to GINA Guidelines

Formoterol is not recommended for children under 4 years of age according to the Global Initiative for Asthma (GINA) guidelines, as it is listed as "NA" (not available/not approved) for this age group. 1

Evidence from Guidelines

• The Expert Panel Report 3 (EPR-3) guidelines clearly indicate that formoterol delivered via dry powder inhaler (DPI) is labeled as "NA" for children 0-4 years of age, meaning it is not approved, no data is available, or safety and efficacy have not been established for this age group 1

• The guidelines specifically note that dosages are only provided for products that have been FDA-approved or have sufficient clinical trial safety and efficacy data in the appropriate age ranges 1

• For children under 4 years of age, there are physiological limitations that affect medication delivery:

  • Most children under 4 years cannot provide sufficient inspiratory flow for adequate lung delivery from dry powder inhalers 1
  • Young children often require assistance with inhalation devices and may need a parent to help with MDI plus valved holding chamber or nebulizer with face mask 1

Age-Based Recommendations for Asthma Management

• The EPR-3 guidelines divide pharmacotherapy recommendations 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

• For children 0-4 years with asthma requiring step 4 care or higher, long-acting beta-agonists (LABAs) may be considered, but specific formulations like formoterol are not approved 1

Safety Considerations

• While studies have examined formoterol safety in older children (4-11 years) and adolescents (12-17 years), showing no increased risk of asthma-related hospitalizations when used with inhaled corticosteroids 2, these findings cannot be extrapolated to children under 4 years

• Physiological differences in very young children affect drug delivery and metabolism:

  • Lower tidal volumes result in lower delivery of aerosols when using face masks in infants and young children 1
  • Most children under 4 years cannot generate sufficient inspiratory flow for dry powder inhalers 1

Alternative Treatments for Young Children

• For children 0-4 years with recurrent wheezing triggered by respiratory tract infections, guidelines conditionally recommend starting a short course of daily inhaled corticosteroids (ICS) at the onset of respiratory infections with as-needed short-acting beta-agonists (SABA) for quick relief 1

• The 2020 focused updates to asthma management guidelines specifically address treatment for 0-4 year olds but do not include formoterol as a recommended option for this age group 1

Common Pitfalls and Caveats

• Attempting to use medications approved for older children in very young children without sufficient evidence of safety and efficacy 1

• Failing to recognize that young children may respond differently to asthma therapies compared to older children and adults, particularly those with predominantly virus-induced wheezing 1

• Using dry powder inhalers in children who cannot generate sufficient inspiratory flow, resulting in inadequate medication delivery 1

• Overlooking the importance of proper delivery devices (such as valved holding chambers with face masks) for young children 1