RT Journal Article
SR Electronic
T1 Brensocatib in non-cystic fibrosis bronchiectasis: ASPEN protocol and baseline characteristics
JF ERJ Open Research
JO erjor
FD European Respiratory Society
SP 00151-2024
DO 10.1183/23120541.00151-2024
VO 10
IS 4
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 http://openres.ersjournals.com/content/10/4/00151-2024.abstract
AB Introduction 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).Methods The ASPEN trial is 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. It 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 aeruginosa status and quality of life, were collected at baseline.Results 1682 adults from 35 countries were randomised from December 2020 to March 2023. Mean age was 61.3 years and 64.7% were female. ∼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 P. aeruginosa-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.Discussion ASPEN baseline characteristics and treatment profiles were representative of a global bronchiectasis population.The phase 3 ASPEN trial enrolled adults with bronchiectasis and a history of exacerbations. This paper outlines the trial design, and reveals that baseline characteristics and treatment patterns were representative of a global bronchiectasis population. https://bit.ly/3vu7RyR