AstraZeneca has announced top-line results from the Phase 3 RISE (Revealing the Impact of Symbicort in reducing Exacerbations in COPD) and CHASE 3 (ChildHood Asthma Safety and Efficacy) studies of the Symbicort budesonide/formoterol fumarate MDI showing that Symbicort met the primary endpoints in both studies.
The RISE study compared twice daily Symbicort MDI (160/4.5 mcg) to twice daily formoterol Turbuhaler in 1,219 patients aged 40 and older who have moderate to very severe COPD. The CHASE 3 study compared Symbicort 80/2.25 mcg and 80/4.5 mcg to 80 mcg of budesonide alone in 279 asthma patients aged 6-12. The CHASE program includes 3 pediatric studies designed in response to a 2009 FDA Complete Response Letter and other US regulatory requirements.
According to the company, “Full results from both studies will be shared when appropriate. CHASE 3 results will be submitted to the FDA and other health authorities in accordance with regulatory requirements, and AstraZeneca will consider additional regulatory submissions based on the full RISE study results.”
AstraZeneca VP and Head Medical Officer, US Medical Affairs Greg Keenan commented, “Positive results from the RISE and CHASE 3 studies reinforce Symbicort as an important treatment option for respiratory patients across a broad range of age groups. AstraZeneca remains committed to following the science to understand the most optimal approach for using Symbicort and determining the right patient type.”
Read the AstraZeneca press release.
