ASPEN (brensocatib 10 mg)
Trial question
What is the effect of brensocatib in patients with bronchiectasis?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
65.0% female
35.0% male
N = 1146
1146 patients (747 female, 399 male).
Inclusion criteria: adult and adolescent patients, aged 12-85 years, with bronchiectasis.
Key exclusion criteria: COPD or asthma if the respiratory symptoms were primarily driven by these diseases; bronchiectasis due to cystic fibrosis; immunodeficiency disorder.
Interventions
N=583 brensocatib (at a dose of 10 mg/day).
N=563 placebo (matching placebo).
Primary outcome
Incidence of annualized rate of pulmonary exacerbations over a 52-week period
1.02
1.29
1.3 events...
1.0 events...
0.6 events...
0.3 events...
0.0 events...
Brensocatib
Placebo
Significant
decrease ▼
Significant decrease in the incidence of annualized rate of pulmonary exacerbations over a 52-week period (1.02 events / y vs. 1.29 events / y; RR 0.79, 95% CI 0.68 to 0.92).
Secondary outcomes
Significant increase in exacerbation-free at week 52 (48.5% vs. 40.3%; RR 1.2, 95% CI 1.06 to 1.37).
No significant difference in least-squares mean decline in FEV1 at week 52 (50 mL vs. 62 mL; MD -11, 95% CI -37 to 14).
No significant difference in the incidence of annualized rate of severe exacerbations (0.14 events / y vs. 0.19 events / y; RR 0.74, 95% CI 0.51 to 1.09).
Safety outcomes
No significant difference in adverse events and serious adverse events.
Conclusion
In adult and adolescent patients, aged 12-85 years, with bronchiectasis, brensocatib was superior to placebo with respect to the incidence of annualized rate of pulmonary exacerbations over a 52-week period.
Reference
James D Chalmers, Pierre-Régis Burgel, Charles L Daley et al. Phase 3 Trial of the DPP-1 Inhibitor Brensocatib in Bronchiectasis. N Engl J Med. 2025 Apr 24;392(16):1569-1581.
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