AstraZeneca has reported positive top-line results from two international, multicentre studies of symbicort to treat chronic obstructive pulmonary disease (COPD) and asthma.
SYMBICORT (budesonide / formoterol fumarate dihydrate) is an inhalation aerosol featuring a combination of inhaled corticosteroid (ICS) and long-acting beta2-adrenergic agonist (LABA).
It has been designed to reduce the inflammation in the lungs and keep airways open.
The Phase IIIb Revealing the Impact of symbicort in reducing Exacerbations in COPD (RISE) study was designed to compare the efficacy of symbicort with formoterol Turbuhaler, both of which were administered on a twice-daily basis to treat moderate to very severe COPD.
It randomised 1,219 adults aged 40 years and older.
The ChildHood Asthma Safety and Efficacy (CHASE) 3 Phase III trial intended to test the efficacy and safety of budesonide / formoterol and symbicort compared with budesonide pMDI, all of which was administered to 279 asthmatic children aged between six to 11, on a twice-daily regimen.
The trial was conducted as a part of the CHASE programme entailing three pediatric clinical studies conducted to meet Pediatric Research Equity Act (PREA) requirements, fulfil the terms of a complete response letter issued by the US Food and Drug Administration (FDA), and respond to FDA feedback.
Results of the trial suggested tolerability of symbicort, as well as reaching its primary endpoints.
AstraZeneca US medical affairs vice-president and head medical officer Greg Keenan 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.”
The company is planning to submit the CHASE 3 results to the US Food and Drug Administration (FDA) and other health authorities.