AstraZeneca (AZN) Announces Significant Results from SYMBICORT Phase 3 in Pediatric Asthma Patients
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Results from the international, multicenter ChildHood Asthma Safety and Efficacy (CHASE) 3 Phase III study showed that SYMBICORT (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol 80/4.5 micrograms significantly improved lung function in pediatric patients between 6 to <12 years of age with asthma versus budesonide 80 micrograms, demonstrating its appropriateness as step-up therapy in this patient population.
The CHASE 3 Phase III study evaluated the efficacy and safety of budesonide/formoterol in a pressurized metered dose inhaler (pMDI) 80/2.25 micrograms, and SYMBICORT pMDI 80/4.5 micrograms, compared with budesonide pMDI 80 micrograms in children with asthma, ages 6 to <12 years, who were given two inhalations twice a day for 12 weeks. The children had previously received either medium-dose inhaled corticosteroid (ICS) or ICS/ long-acting beta2-adrenergic agonists (LABA). The primary efficacy endpoint was change from baseline pre-dose (randomization) to 1-hour post-dose forced expiratory volume in one second (FEV1) at week 12.
AstraZeneca conducted the CHASE 3 study after the US Food and Drug Administration (FDA) requested additional data on budesonide and formoterol, specifically regarding the impact of different doses, in pediatric asthma patients between 6 to <12 years of age.
The study results showed changes from baseline at week 12 in 1-hour post-dose FEV1 and 15-minute post-dose FEV1 were significantly greater with SYMBICORT 80/4.5 micrograms two inhalations twice daily versus budesonide 80 micrograms two inhalations twice daily (both p≤0.015), but not budesonide/formoterol 80/2.25 micrograms two inhalations twice daily versus budesonide 80 micrograms two inhalations twice daily. The change from baseline in 1-hour post-dose PEF (peak expiratory flow) was superior at week 12 with SYMBICORT 80/4.5 micrograms versus other treatments (p<0.05).
There were no notable differences in safety profiles between either of the budesonide/formoterol doses and budesonide or between the two budesonide/formoterol doses. Among the most common adverse events, upper respiratory tract infection, pharyngitis, headache, and vomiting were more frequent, with budesonide/formoterol doses compared to the budesonide 80 micrograms dose.
The CHASE 3 results were submitted to the FDA and other health authorities in accordance with regulatory requirements.
Gregory Keenan, Vice President, Medical Affairs and US Head Medical Officer, said: “These safety and efficacy results from the CHASE 3 study indicate SYMBICORT may offer an important asthma treatment option for the appropriate pediatric populations. We look forward to working with the regulatory authorities to help make SYMBICORT available to this population of children with asthma.”
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