The Food and Drug Administration (FDA) has approved Symbicort (budesonide and formoterol fumarate dihydrate; AstraZeneca) Inhalation Aerosol 80/4.5mcg for the treatment of asthma in pediatric patients aged 6 to 12 years.

The pediatric approval was based on the results of the Phase 3 CHASE (ChildHood Asthma Safety and Efficacy) 3 trial. This was a 12-week, randomized, double-blind, multicenter study which compared Symbicort 80/4.5mcg delivered in a pressurized metered-dose inhaler (pMDI) vs. budesonide pMDI 80mcg, both administered twice daily in 184 asthma patients 6 to 12 years of age.

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Treatment with Symbicort 80/4.5mcg led to a statistically significant improvement in lung function in pediatric patients with asthma aged 6–12 years who were symptomatic on low-dose inhaled corticosteroid vs. budesonide pMDI 80mcg. The safety profiles of children ages 6 to 12 treated with Symbicort were similar to those of patients ≥12 years old. Patients who received Symbicort experienced upper respiratory tract infection, pharyngitis, headache, and rhinitis more frequently than those who received budesonide. 

Symbicort 80/4.5mcg and 160/4.5mcg are already approved to treat asthma in patients aged ≥12 years. Symbicort 160/4.5mcg is also indicated for maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults. Both strengths are available as inhalers containing 120 actuations each.

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