SYGMA 1 O’Byrne (2018) | RCT, parallel-group, double-blind placebo-controlled | 52 weeks | 261 sites, 18 countries | Adults and adolescents (≥12 years) | 2559 (1277 versus 1282) | Mean percentage of electronically recorded weeks with well-controlled asthma per patient (noninferiority)¶ | Budesonide-formoterol 200/6 μg (Symbicort Turbuhaler, AstraZeneca) one inhalation as needed plus twice-daily placebo | Budesonide 200 μg (Pulmicort Turbuhaler, AstraZeneca) twice daily plus terbutaline 500 μg (Turbuhaler) as needed |
SYGMA 2 Bateman (2018) | RCT, parallel-group, double-blind placebo-controlled | 52 weeks | 350 sites, 25 countries | Adults and adolescents (≥12 years) | 4176 (2089 versus 2087) | Annualised rate of severe exacerbations (non-inferiority)+ | Budesonide-formoterol 200/6 μg (Symbicort Turbuhaler, AstraZeneca) one inhalation as needed plus twice-daily placebo | Budesonide 200 μg (Pulmicort Turbuhaler, AstraZeneca) twice daily plus terbutaline 500 μg (Turbuhaler) as needed |
Novel start Beasley (2019) | RCT, parallel-group, open-label, real-world | 52 weeks | 16 sites, 4 countries | Adults (≥18 years) | 425 (220 versus 225) | Annualised rate of asthma exacerbations (superiority) | Budesonide-formoterol 200/6 μg (Symbicort Turbuhaler, AstraZeneca) one inhalation as-needed | Budesonide 200 μg (Pulmicort Turbuhaler, AstraZeneca) twice daily plus albuterol 100 μg (Ventolin pMDI) two inhalations as needed |
PRACTICAL Hardy (2019) | RCT, parallel-group, open-label, real-world | 52 weeks | 15 sites, 1 country | Adults and adolescents (≥18 years) | 885 (437 versus 448) | Number of severe exacerbations per patient per year (superiority) | Budesonide-formoterol 200/6 μg (Symbicort Turbuhaler, AstraZeneca) one inhalation as needed | Budesonide 200 μg (Pulmicort Turbuhaler, AstraZeneca) twice daily plus terbutaline 250 μg (Bricanyl Turbuhaler, AstraZeneca) two inhalations as needed |