Budesonide/formoterol Turbuhaler® as needed in mild asthma: results of SYGMA-1 and SYGMA-2 trials (SYmbicort® Given as needed in Mild Asthma)

Abstract

According to the modern concepts, asthma is a heterogeneous disease characterized by chronic airway inflammation and respiratory symptoms, which vary in time and intensity and manifest together with variable obstruction of the airways. Asthma is responsible for the deterioration of health status and quality of life in approximately 339 million of adult patients and children worldwide. Despite the fact that asthma is a chronic inflammatory disease, patients with asthma generally inadequately receive anti-inflammatory therapy in real clinical practice and rely on short-acting beta2-agonists (SABA) too much; this can “mimic” worsening of asthma symptoms. SABA monotherapy “on demand” does not affect chronic airway inflammation, underlying asthma occurrence and progression. As a result, such patients still have the risk of asthma exacerbation and disease progression. Therefore, the need of a new therapeutic strategy for patients with milder asthma (steps 1 and 2), which would provide anti-inflammatory treatment considering the low adherence to the regular maintenance therapy and high dependency on SABA, is obvious. Such approach has become available after the SYGMA (SYmbicort® Given as needed in Mild Asthma) trial was completed. According to the results of this trial, budesonide/formoterol 160/4.5 µg/dose as needed was superior to as needed SABA in better asthma control and decrease in severe asthma exacerbation rate by 64% (p < 0.001). Results of SYGMA 1 and 2 trials also demonstrated that budesonide/formoterol 160/4.5 µg/dose as needed was noninferior compared to regular treatment with budesonide in preventing severe asthma exacerbations while the cumulative dose of budesonide was reduced by ≥75%.