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A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis

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

NCT04594369•Insmed Incorporated

View on ClinicalTrials.gov

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.

Eligibility

Age

12 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 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.
•2. 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.
•3. 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.
•4. 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.
•5. 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.
•6. 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

•1. A primary diagnosis of chronic obstructive pulmonary disease (COPD) or asthma as judged by the Investigator.
•2. Bronchiectasis due to cystic fibrosis.
•3. Current smokers as defined per Centers for Disease Control (CDC).
•4. Known or suspected immunodeficiency disorder, including history of invasive opportunistic infections.
•5. Known history of human immunodeficiency virus (HIV) infection.
•6. Currently being treated for nontuberculous mycobacteria (NTM) lung infection, allergic bronchopulmonary aspergillosis, or tuberculosis (TB).
•7. Active and current symptomatic infection by 2019 corona virus disease (COVID-19).
•8. Inability to follow the procedures of the study (eg, due to language problems or psychological disorders).
•9. Receiving medications or therapy that are prohibited as concomitant medications.
•10. Previously participated in a clinical trial for brensocatib.
+7 more criteria

Locations (373)

USA013

Birmingham, Alabama, United States

USA080

Conway, Arkansas, United States

USA044

Little Rock, Arkansas, United States

USA104

Fresno, California, United States

USA055

Los Angeles, California, United States

USA029

Newport Beach, California, United States

USA102

Northridge, California, United States

USA022

Palm Springs, California, United States

USA024

Sacramento, California, United States

USA035

San Diego, California, United States

Key Dates

Start Date

December 1, 2020

Primary Completion Date

October 28, 2024

Completion Date

October 28, 2024

Last Updated

December 16, 2025

Enrollment

1,767

ACTUAL participants

Conditions

Non-Cystic Fibrosis Bronchiectasis

Interventions

Brensocatib 10 mg

DRUG

Brensocatib 25 mg

DRUG

Placebo

DRUG

A Clinical Study of RSS0343 in Healthy Subjects

NCT07289464

Non-cystic Fibrosis Bronchiectasis

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TERMINATEDPHASE1

A Study in Patients With Non-cystic Fibrosis Bronchiectasis to Test How Well Different Doses of BI 1323495 Are Tolerated and How BI 1323495 Affects Biomarkers of Inflammation

NCT04656275

Non-cystic Fibrosis Bronchiectasis

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UNKNOWNPHASE2

Inhalations of Ultra-low Doses of Melphalan for the Treatment of Non-cystic Fibrosis Bronchiectasis

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 16, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis

Inclusion Criteria

Exclusion Criteria

A Clinical Study of RSS0343 in Healthy Subjects

A Study in Patients With Non-cystic Fibrosis Bronchiectasis to Test How Well Different Doses of BI 1323495 Are Tolerated and How BI 1323495 Affects Biomarkers of Inflammation

Inhalations of Ultra-low Doses of Melphalan for the Treatment of Non-cystic Fibrosis Bronchiectasis

Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis Bronchiectasis

The Effects of Pulmonary Rehabilitation in Patients With Non-cystic Fibrosis Bronchiectasis