A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects With Non-Cystic Fibrosis Bronchiectasis - The ASPEN Study
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects With Non-Cystic Fibrosis Bronchiectasis - The ASPEN Study
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.
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:
Ciudad Autónoma de Buenos Aires, Buenos Aires C1121ABE, Argentina
Ciudad Autónoma de Buenos Aires, Buenos Aires C1122AAK, Argentina
Ciudad Autónoma de Buenos Aires, Buenos Aires C1414AIF, Argentina
Ciudad Autónoma de Buenos Aires, Buenos Aires C1425AZB, Argentina
Ciudad Autónoma de BuenosAires, Buenos Aires C1425BEN, Argentina
Ciudad Autónoma de BuenosAires, Buenos Aires C1426ABP, Argentina
Bogota DC, 110131, Colombia
Copenhagen O, Capital 2100, Denmark
Toon-Shi, Ehime 791-0203, Japan
Iizuka-Shi, Hukuoka 820-0018, Japan
Kasama-Shi, Ibaraki 309-1703, Japan
Naka-gun, Ibaraki 319-1113, Japan
Yokohama-Shi Konan-Ku, Kanagawa 234-0054, Japan
Koshi Shi, Kumamoto 861-1196, Japan
Matsusaka-shi, Mie-ken 515-8544, Japan
Chuo-ku, Niigata 951-8510, Japan
Shinagawa-ku, Tokyo 140-8522, Japan
Shinagawa-ku, Tokyo 141-8625, Japan
Shinjuku-ku, Tokyo 160-8582, Japan
Shinjuku-ku, Tokyo 1628655, Japan
Shimonoseki-Shi, Yamaguchi 750-0041, Japan
Kita Kyushu-shi, 807-8556, Japan
Meguro-ku, 152-0021, Japan
Toyonaka-shi, 560-8552, Japan
Spisská Nová Ves, 052 01, Slovakia
Nakhonnayok, Changwat Nakhon Nayok 26120, Thailand
Muang, Changwat Nonthaburi 11000, Thailand
Atakum, Samsun 55270, Turkey (Türkiye)