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 (ASPEN)

  • End date
    Mar 22, 2024
  • participants needed
  • sponsor
    Insmed Incorporated
Updated on 27 October 2022


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.

Condition Non-Cystic Fibrosis Bronchiectasis
Treatment Placebo, Brensocatib 10 mg, Brensocatib 25 mg
Clinical Study IdentifierNCT04594369
SponsorInsmed Incorporated
Last Modified on27 October 2022


Yes No Not Sure

Inclusion Criteria

Provide their signed study informed consent to participate
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
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
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
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
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
Known history of human immunodeficiency virus (HIV) infection
Currently being treated for nontuberculous mycobacteria (NTM) lung infection, allergic bronchopulmonary aspergillosis, or tuberculosis (TB)
Active and current symptomatic infection by COVID-19
Inability to follow the procedures of the study (eg, due to language problems or psychological disorders)
Receiving medications or therapy that are prohibited as concomitant medications
Received any live attenuated vaccine within 4 weeks prior to the first administration of brensocatib
Suffering an exacerbation 4 weeks before Screening or during the Screening period
Participated in any other interventional clinical studies within 3 months before Screening Visit
History of alcohol or drug abuse within 6 months prior to the Screening Visit
Is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study
Known history of hypersensitivity to brensocatib or any of its excipients
Previously participated in a clinical trial for brensocatib
Adult participants only: Have compliance issues with completion of electronic diary entries during the Screening Period and in the opinion of the Investigator, compliance is unlikely to improve during the study
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note