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About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Provide their signed study informed consent to participate.
a. Adolescent participants must have signed study assent form to participate, and the adolescent's parent or legal guardian must have provided signed informed consent for the adolescent 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.
a. Adolescent participants are required to have at least 1 pulmonary exacerbation in the prior 12 months.
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
Primary purpose
Allocation
Interventional model
Masking
1,767 participants in 3 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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