A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-… (NCT04594369) | Clinical Trial Compass
CompletedPhase 3
A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis
United States1,767 participantsStarted 2020-12-01
Plain-language 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.
Who can participate
Age range12 Years – 85 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Provide their signed study informed consent to participate.
✓. Clinical history consistent with non-cystic fibrosis bronchiectasis (NCFBE) (cough, chronic sputum production and/or recurrent respiratory infections) that is confirmed by chest computerized tomography (CT) scan.
✓. At least 2 PEs defined by need for antibiotic prescription by a physician for the signs and symptoms of respiratory infections in the past 12 months before the Screening Visit.
✓. Women must be postmenopausal (defined as no menses for 12 months without an alternative medical cause), surgically sterile, or using highly effective contraception (ie, methods that can achieve a failure rate \<1% per year when used consistently and correctly) from Day 1 to at least 90 days after the last dose.
✓. Male participants with female partners of childbearing potential must be using effective contraception from Day 1 to at least 90 days after the last dose.
✓. Male participants with pregnant or non-pregnant women of child-bearing potential partners must use condoms to avoid potential exposure to the embryo/fetus.
Exclusion criteria
✕. A primary diagnosis of chronic obstructive pulmonary disease (COPD) or asthma as judged by the Investigator.
✕. Bronchiectasis due to cystic fibrosis.
✕. Current smokers as defined per Centers for Disease Control (CDC).
✕. Known or suspected immunodeficiency disorder, including history of invasive opportunistic infections.