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Efficacy and safety of brensocatib in Japanese patients with non-cystic fibrosis bronchiectasis: Analysis of the ASPEN trial

Lookup NU author(s): Professor Anthony De SoyzaORCiD

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Abstract

© 2026 The AuthorBackground: In the ASPEN trial (NCT04594369), brensocatib 10 mg and 25 mg significantly reduced the burden of pulmonary exacerbations (annualized rate [primary endpoint], time to first, proportion exacerbation-free) over 52 weeks vs placebo in patients with bronchiectasis; brensocatib 25 mg significantly reduced lung function decline and nominally significantly improved patient-reported symptoms. Here we report efficacy and safety for Japanese patients. Methods: Adults with bronchiectasis with ≥2 exacerbations in the 12 months before screening were randomized to once-daily brensocatib (10 mg or 25 mg) or placebo for 52 weeks. Endpoints included annualized exacerbation rate, time to first exacerbation, proportion remaining exacerbation-free, change from baseline in lung function, severe exacerbation rate, and change from baseline in patient-reported symptoms. Results: Baseline characteristics of Japanese patients (n = 87) were generally consistent across groups. Brensocatib 10 mg and 25 mg reduced the annualized exacerbation rate vs placebo (rate ratio, 0.37 [95 % CI, 0.16–0.87]; 0.32 [0.14–0.75]), prolonged time to first exacerbation, and increased odds of remaining exacerbation-free. The annualized severe exacerbation rate was lower with brensocatib 10 mg and 25 mg vs placebo (rate ratio, 0.11 [0.01–1.04]; 0.30 [0.06–1.62]). Brensocatib, particularly at the 25 mg dose, also reduced lung function decline vs placebo (LS mean difference: forced expiratory volume in 1 s, 97 mL [95 % CI, 32–162]; forced vital capacity, 164 mL [84−244]) and improved patient-reported symptoms. Adverse events were similar across groups. Conclusions: Consistent with overall ASPEN results, brensocatib 10 mg and 25 mg reduced exacerbation frequency vs placebo in Japanese patients with bronchiectasis. Lung function, patient-reported symptoms, and safety data were consistent with overall ASPEN trial results. Clinical trial registration: NCT04594369.

Publication metadata

Author(s): Morimoto K, Chalmers JD, Burgel P-R, Daley CL, De Soyza A, Mauger D, Metersky ML, Zhang X, Li S, Goto Y, Teper A, Fernandez C, Hasegawa N

Publication type: Article

Publication status: Published

Journal: Respiratory Investigation

Year: 2026

Volume: 64

Issue: 2

Print publication date: 01/03/2026

Online publication date: 09/01/2026

Acceptance date: 18/12/2025

Date deposited: 19/01/2026

ISSN (print): 2212-5345

ISSN (electronic): 2212-5353

Publisher: Elsevier B.V.

URL: https://doi.org/10.1016/j.resinv.2025.101357

DOI: 10.1016/j.resinv.2025.101357

Data Access Statement: The data that support the findings of this study are available in the published article

PubMed id: 41519018

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