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Trial question
What is the role of patient-activated reliever-triggered ICS therapy in Black and Latinx adults with asthma?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
84.0% female
16.0% male
N = 1201
1201 patients (1005 female, 196 male)
Inclusion criteria: Black and Latinx adult patients with moderate-to-severe asthma
Key exclusion criteria: being prescribed daily inhaled glucocorticoids; uncontrolled asthma; previous asthma exacerbation leading to the use of systemic glucocorticoids or overnight hospitalization
Interventions
N=600 reliever-triggered ICS (80 mcg beclomethasone dipropionate plus usual care)
N=601 usual care (provider-enhanced usual care)
Primary outcome
Annualized rate of severe asthma exacerbations
0.69
0.82
0.8
0.6
0.4
0.2
0.0
Reliever-triggered inhaled
corticosteroid
Usual
care
Significant
decrease ▼
Significant decrease in annualized rate of severe asthma exacerbations (0.69 vs. 0.82 ; HR 0.85, 95% CI 0.72 to 0.99)
Secondary outcomes
Significant increase in mean improvement in asthma control test scores (3.4 points vs. 2.5 points; MD 0.9, 95% CI 0.5 to 1.2)
Significant increase in mean improvement in asthma symptom utility index scores (0.12 points vs. 0.08 points; MD 0.04, 95% CI 0.02 to 0.05)
Borderline significant decrease in annualized rate of missed days of work, school, or usual activities (13.4 days vs. 16.8 days; RR 0.8, 95% CI 0.67 to 0.95)
Safety outcomes
No significant differences in serious adverse events, asthma-related hospitalizations.
Conclusion
In Black and Latinx adult patients with moderate-to-severe asthma, reliever-triggered ICS was superior to usual care with respect to annualized rate of severe asthma exacerbations.
Reference
Elliot Israel, Juan-Carlos Cardet, Jennifer K Carroll et al. Reliever-Triggered Inhaled Glucocorticoid in Black and Latinx Adults with Asthma. N Engl J Med. 2022 Apr 21;386(16):1505-1518.
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