SYGMA 1

Symbicort Given As Needed in Mild Asthma 1

Patient / Population Intervention / Exposure Comparison Outcome

In 3,849 patients with mild asthma, PRN budesonide-formoterol reduced severe exacerbations compared with PRN terbutaline.

3,849

Design

Multicentre RCT

Endpoint

Well-controlled asthma weeks

Relevance

ResultWell-controlled asthma weeks 34.4% vs 31.1% (OR 1.14, 95% CI 1.00–1.30, p=0.046); severe exacerbation rate reduced 64% vs as-needed SABA (RR 0.36, 95% CI 0.27–0.49).

O'Byrne PM, et al. N Engl J Med. 2018;378(20):1865-1876. 10.1056/NEJMoa1715274

Discussion & critique

Foundational evidence for GINA's recommendation against SABA-only therapy; PRN ICS-formoterol is the new standard for mild asthma.