WHAT IS THE PREFERRED THERAPY WHEN INITIATING DAILY CONTROLLER MEDICATIONS?
ICS therapy. A low-dose daily ICS is the preferred therapy when initiating daily controller treatment.6 Many clinical trials with ICSs have enrolled patients 12 years or older. The generalizability of these results to younger children has not been clearly established. However, a recent meta-analysis of 29 studies in infants and preschoolers aged 1 month to 5 years who received an ICS showed that in 2805 children from 16 studies, those who received an ICS had significantly fewer wheezing/ asthma exacerbations (18.0%) than those who received placebo (32.1%; relative risk: 0.59; 95% confidence interval: 0.52 - 0.67; I = .0001).27 Moreover, children on an ICS used significantly less albuterol and had significantly greater mean improvements from baseline in symptoms score, forced expiratory volume in 1 second, and peak expiratory flow (P = .0001).
FDA-approved ICSs for the treatment of asthma in young children are limited. Budesonide inhalation suspension administered with a jet nebulizer–compressor is approved for children aged 12 months to 8 years, has been shown to be efficacious and tolerable in this agegroup, 28 and is the only ICS indicated for use in children 3 years or younger. 6 Several other combinations of ICSs and delivery devices are available for use in infants and young children, with approval by the FDA down to 4 years of age for mometasone furoate inhalation powder and fluticasone propionate hydrofluoroalkane inhalation aerosol. Moreover, the National Asthma Education and Prevention Program does provide dosage recommendations for the use of fluticasone propionate MDI for children aged 0 to 4 years.6 Use of fluticasone MDI with a valved spacer and a face mask was studied in the PEAK trial, which showed that low-dose daily ICS therapy is not a disease modifier but does decrease exacerbations and symptom burden in preschoolaged children with risk factors based on the mAPI while the child is on treatment.26
Montelukast. An alternative approved option for this age-group is the orally administered leukotriene receptor antagonist montelukast.6 A double-blind, randomized study of 689 children aged 2 to 5 years with asthma showed that montelukast treatment over 12 weeks is significantly more effective than placebo in improving daytime asthma symptoms, the percentage of days with asthma symptoms, and the need for a rescue SABA or OCS (P ≤ .012).6,29 Montelukast also has been shown to be effective in reducing asthma exacerbations in children aged 2 to 5 years (N = 549) with viral-associated intermittent asthma.30 In school-aged children, studies show the effectiveness of ICSs to be greater than that of montelukast.6,31-33 Therefore, while both ICS and montelukast are effective, an ICS is the preferred longterm daily controller medication in preschool-aged children.6
Cromolyn. Cromolyn is available as an MDI and as a nebulizer solution, and is currently approved for use in children 2 years and older.6 However, the symptom benefits of cromolyn in preschool-aged children are inconsistent.34 According to current guidelines, cromolyn is to be used as an alternative, but not preferred, treatment at step 2 of care. If adequate asthma control is not achieved and maintained after 4 to 6 weeks, the preferred medication should be tried before stepping up therapy.6