Patients with controlled and uncontrolled asthma had a comparable risk of serious asthma-related events and a lower risk of asthma exacerbations when formoterol was combined with budesonide, according to AstraZeneca.
The study compared the safety of formoterol, a LABA, used in combination with budesonide, an inhaled corticosteroid (ICS)–the two active therapies in Symbicort pressurized metered dose inhaler (pMDI)–against budesonide (pMDI) to evaluate the risk of serious asthma-related events. These events are defined as a composite endpoint of asthma related events including asthma-related deaths, intubations, and hospitalizations, with time to first serious asthma-related event as the primary endpoint.
The results showed a comparable risk of serious asthma-related events when formoterol was combined with budesonide versus budesonide alone. Based on a predefined non-inferiority margin, the upper limit of the 95% confidence interval (CI) for the hazard ratio (HR) of the primary safety endpoint needed to be less than two. As a result, the findings demonstrated statistical non-inferiority of Symbicort to budesonide for time to first serious asthma-related event (HR [1.073], 95% CI, [0.698-1.650]). Furthermore, Symbicort therapy resulted in a 16.5% lower risk of asthma exacerbations than budesonide (HR, 0.835; 95% CI, 0.745 to 0.937; P = 0.002).
Full study results are now available in The New England Journal of Medicine. The study began in 2011 as a post-marketing requirement by the US FDA and all manufacturers of LABA-containing products indicated for the treatment of asthma in the US were required to conduct similar studies evaluating the safety of LABAs when used in combination with an ICS.
Gregory Keenan, Vice President and Head Medical Officer, US Medical Affairs, said: “These findings reconfirm the well-established safety profile of Symbicort as demonstrated in our robust clinical program and extensive post-marketing surveillance from around the world. We are pleased to see the importance of ICS/LABA combination therapy in the management of asthma further validated through this study’s findings and its publication in The New England Journal of Medicine.”