Brensocatib in non-cystic fibrosis bronchiectasis: ASPEN protocol and baseline characteristics.

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 placebo. Comprehensive clinical data, including demographics, disease severity, lung function, 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 . 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 positive negative patients, lung function was lower, with greater long-term macrolide (21.5% 14.0%) and inhaled corticosteroid use (63.5% 53.9%). There was wide regional variation in long-term antibiotic use in patients with bronchiectasis and .

DISCUSSION

ASPEN baseline characteristics and treatment profiles were representative of a global bronchiectasis population.