6/29/23, 11:57 PM SYGMA 2 Pathway Feedback Search Clinical Topics Home Studies SYGMA 2 SYGMA 2 Disease Asthma Trial question Is budesonide-formoterol noninferior to budesonide maintenance therapy in patients with mild asthma? Study design Multi-center Double blinded RCT Population Characteristics of study participants 62.6% female N = 4215 37.4% male 4215 patients (2597 female, 1579 male) Inclusion criteria: patients with mild asthma and were eligible for treatment with regular ICSs Key exclusion criteria: worsening asthma involving change in asthma treatment or the usee of systemic corticosteroids in the previous 30 days, current or former smoking with a history of 10 pack-years, and a history of life-threatening asthma Interventions N=2089 budesonide and formoterol (twice-daily placebo plus budesonide 200 g and formoterol 6 g used as needed) N=2087 budesonide maintenance (twice-daily budesonide 200 g plus terbutaline 0.5 mg as needed) https://web.pathway.md/studies/recGVelCQxKJKG12b 1/2 6/29/23, 11:57 PM SYGMA 2 Pathway Primary outcome Percentage of patients achieving an improvement in ACQ-5 score 44.3 % 44.3 40.3 33.2 % 22.1 % 11.1 % Borderline significant decrease 0.0 % Budesonide and formoterol Budesonide maintenance Borderline significant decrease in the percentage of patients achieving an improvement in ACQ-5 score (40.3% vs. 44.3%; OR 0.86, 95% CI 0.75 to 0.99) Safety outcomes No significant difference in adverse events. Conclusion In patients with mild asthma and were eligible for treatment with regular ICSs, budesonide and formoterol were noninferior to budesonide maintenance with respect to the percentage of patients achieving an improvement in ACQ-5 score. Reference Bateman ED, Reddel HK, O'Byrne PM et al. As-Needed Budesonide-Formoterol versus Maintenance Budesonide in Mild Asthma. N Engl J Med. 2018 May 17;378(20):1877-1887. Open reference URL https://web.pathway.md/studies/recGVelCQxKJKG12b 2/2