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.
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.
For more information call (800) 237-8898 or visit Symbicort.com.