SYGMA 2
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
62.0% female
38.0% male
N = 4176
4176 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 mcg and formoterol 6 mcg used as needed).
N=2087 budesonide maintenance (twice-daily budesonide 200 mcg plus terbutaline 0.5 mg as needed).
Primary outcome
Percentage of patients achieving an improvement in ACQ-5 score
40.3%
44.3%
44.3 %
33.2 %
22.1 %
11.1 %
0.0 %
Budesonide and
formoterol
Budesonide
maintenance
Significant
decrease ▼
NNH = 25
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.
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