A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis

Summary

The primary objective of this study is to evaluate the effect of brensocatib at 10 mg and 25 mg compared with placebo on the rate of pulmonary exacerbations (PEs) over the 52-week treatment period.

Timeline

Start

2020-12-01

Primary completion

2024-10-28

Completion

2024-10-28

Publications

• Addrizzo-Harris D, Chalmers JD, Aliberti S, Burgel PR, Morrissey BM, Zhang X, Fan C, Lauterio M, Fucile S, Griffis D, Teper A. Efficacy and Safety of Brensocatib in Participants of Asian Race with Non-cystic Fibrosis Bronchiectasis: A Subgroup Analysis of the ASPEN Trial. Pulm Ther. 2026 Jul 16. doi: 10.1007/s41030-026-00375-w. Online ahead of print.
• Morimoto K, Chalmers JD, Burgel PR, Daley CL, De Soyza A, Mauger D, Metersky ML, Zhang X, Li S, Goto Y, Teper A, Fernandez C, Hasegawa N. Efficacy and safety of brensocatib in Japanese patients with non-cystic fibrosis bronchiectasis: Analysis of the ASPEN trial. Respir Investig. 2026 Mar;64(2):101357. doi: 10.1016/j.resinv.2025.101357. Epub 2026 Jan 9.
• Chalmers JD, Burgel PR, Daley CL, De Soyza A, Haworth CS, Mauger D, Loebinger MR, McShane PJ, Ringshausen FC, Blasi F, Shteinberg M, Mange K, Teper A, Fernandez C, Zambrano M, Fan C, Zhang X, Metersky ML; ASPEN Investigators. Phase 3 Trial of the DPP-1 Inhibitor Brensocatib in Bronchiectasis. N Engl J Med. 2025 Apr 24;392(16):1569-1581. doi: 10.1056/NEJMoa2411664.
• Chalmers JD, Burgel PR, Daley CL, De Soyza A, Haworth CS, Mauger D, Mange K, Teper A, Fernandez C, Conroy D, Metersky M. Brensocatib in non-cystic fibrosis bronchiectasis: ASPEN protocol and baseline characteristics. ERJ Open Res. 2024 Jul 22;10(4):00151-2024. doi: 10.1183/23120541.00151-2024. eCollection 2024 Jul.
• Chalmers JD, Usansky H, Rubino CM, Teper A, Fernandez C, Zou J, Mange KC. Pharmacokinetic/Pharmacodynamic Evaluation of the Dipeptidyl Peptidase 1 Inhibitor Brensocatib for Non-cystic Fibrosis Bronchiectasis. Clin Pharmacokinet. 2022 Oct;61(10):1457-1469. doi: 10.1007/s40262-022-01147-w. Epub 2022 Jul 25.

Drugs

Indications