RT Journal Article
SR Electronic
T1 Brensocatib in non–cystic fibrosis bronchiectasis: ASPEN protocol/baseline characteristics
JF ERJ Open Research
JO erjor
FD European Respiratory Society
SP 00151-2024
DO 10.1183/23120541.00151-2024
A1 Chalmers, James D.
A1 Burgel, Pierre-Régis
A1 Daley, Charles L.
A1 De Soyza, Anthony
A1 Haworth, Charles S.
A1 Mauger, David
A1 Mange, Kevin
A1 Teper, Ariel
A1 Fernandez, Carlos
A1 Conroy, Dan
A1 Metersky, Mark
YR 2024
UL https://publications.ersnet.org//content/early/2024/03/28/23120541.00151-2024.abstract
AB Brensocatib is an investigational, oral, reversible inhibitor of dipeptidyl peptidase-1 shown to prolong time to first exacerbation in adults with bronchiectasis. Outlined here are the clinical trial design, and baseline characteristics and treatment patterns of adult patients enrolled in the phase 3 ASPEN trial (NCT04594369).A global study enrolling patients with a clinical history consistent with bronchiectasis (cough, chronic sputum production, and/or recurrent respiratory infections), diagnosis confirmed radiologically, and ≥2 exacerbations in the prior 12 months, ASPEN was designed to evaluate the impact of two brensocatib doses (10 mg and 25 mg) on exacerbation rate over a 52-week treatment period versus placebo. Comprehensive clinical data, including demographics, disease severity, lung function, Pseudomonas (P.) aeruginosa status, and quality of life, were collected at baseline.1682 adults from 35 countries were randomised from December 2020 to March 2023. Mean age was 61.3 years and 64.7% were female. Approximately 70% had moderate-to-severe Bronchiectasis Severity Index (BSI) scores, 29.3% had ≥3 exacerbations in the prior 12 months, and 35.7% were positive for P. aeruginosa. Mean BSI scores were highest in Australia/New Zealand (8.3) and lowest in Latin America (5.9). Overall, the most common aetiology was idiopathic (58.4%). In P. aeruginosa–positive versus –negative patients, lung function was lower, with greater long-term macrolide (21.5% versus 14.0%) and inhaled corticosteroid use (63.5% versus 53.9%). There was wide regional variation in long-term antibiotic use in patients with bronchiectasis and P. aeruginosa.ASPEN baseline characteristics and treatment profiles were representative of a global bronchiectasis population.FootnotesThis manuscript has recently been accepted for publication in the ERJ Open Research. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJOR online. Please open or download the PDF to view this article.Conflict of interest: James D. Chalmers reports receiving grants and personal fees from AstraZeneca, Boehringer Ingelheim, GSK, Zambon, and Insmed Incorporated, a grant from Gilead, and personal fees from Novartis and Chiesi.Conflict of interest: Pierre-Régis Burgel reports grants from Vertex and GSK, outside the submitted work. Dr Burgel also reports Clinical trials: acting as main investigator; advisory activity for Astra-Zeneca, Chiesi, GSK, Insmed Incorporated, MSD, Viatris, Vertex, Zambon; Substantial financial contributions to the budget of an institution you are responsible for GSK, Vertex, Association Vaincre la Mucoviscidose, Société Française de la Mucoviscidose, Filière MUCO-CFTR.Conflict of interest: Charles L. Daley reports grant support, advisory board fees, and consulting fees from Insmed Incorporated. Dr. Daley also reports grant support from AN2 Therapeutics, Bugworks, Paratek Pharmaceuticals, Juvabis; advisory board work with AN2 Therapeutics, Aztrazeneca, Cepheid, Hyfe, MannKind, Matinas Biopharma, NobHill, Spero Therapeutics, Zambon; consulting with Genentech, Pfizer; data monitoring committee work with Otsuka Pharmaceutical, Eli Lilly and Company, Bill and Melinda Gates Foundation.Conflict of interest: Anthony De Soyza reports grants and fees from AstraZeneca, Boehringer Ingelheim, Bayer, Chiesi, Gilead Sciences, GSK, Insmed Incorporated, and Zambon.Conflict of interest: Charles S. Haworth reports receiving consultancy/speaker fees from 30 Technology, CSL Behring, Chiesi, Insmed Incorporated, Janssen, LifeArc, Meiji, Mylan, Novartis, Pneumagen, Shinogi, Teva, Vertex, and Zambon.Conflict of interest: David Mauger reports grants from NHLBI and drugs for NIH-funded clinical trials from Genentech, GSK, OM Pharma, Sanofi-Regeneron.Conflict of interest: Kevin Mange, Ariel Teper, Carlos Fernandez, and Dan Conroy are employees and shareholders in Insmed Incorporated.Conflict of interest: Mark L. Metersky reports receiving consulting fees from AN2 Therapeutics, Boehringer Ingelheim, Insmed Incorporated, Renovion, Tactile Inc., and Zambon.Conflict of interest: James D. Chalmers, Pierre-Régis Burgel, Charles L. Daley, Anthony De Soyza, Charles S. Haworth, David Mauger, and Mark Metersky served as members of the ASPEN trial steering committee. James D. Chalmers, Pierre-Régis Burgel, Charles L. Daley, Anthony De Soyza, Charles S. Haworth, and Mark Metersky were investigators in the ASPEN trial.