AstraZeneca has announced positive top-line results from two international, multicenter studies in adult and pediatric patients with chronic obstructive pulmonary disease (COPD) and asthma, respectively, that showed SYMBICORT (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol was well tolerated and achieved the primary endpoints in both studies.
“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.”
The phase IIIb Revealing the Impact of SYMBICORT in reducing Exacerbations in COPD (RISE) study compared the efficacy of SYMBICORT pressurized metered dose inhaler (pMDI) (160/4.5 micrograms) two inhalations twice-daily and formoterol Turbuhaler (4.5 micrograms) two inhalations twice-daily in reducing exacerbations in adult patients with moderate to very severe COPD. The study randomized 1,219 adults aged 40 years and older, and involved more than 200 study sites in 10 countries.
The ChildHood Asthma Safety and Efficacy (CHASE) 3 phase III study evaluated the efficacy and safety of budesonide/formoterol in a pMDI 80/2.25 micrograms, and SYMBICORT pMDI 80/4.5 micrograms, compared with budesonide pMDI 80 micrograms, all given two inhalations twice-daily, in children ages 6 to <12 years with asthma. The study randomized 279 children 6 to <12 years of age, from which 273 received treatment, and involved a total of 88 study centers located in four countries. The study is part of the CHASE program made up of three pediatric clinical studies conducted to meet Pediatric Research Equity Act (PREA) requirements, fulfill the terms of a Complete Response Letter issued by the FDA, and respond to FDA feedback.
Greg Keenan, vice president and head medical officer, U.S. Medical Affairs, said, “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.”
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.
