A Study to Assess the Effectiveness, Safety, and Tolerability of Brensocatib in Participants with Non-Cystic Fibrosis Bronchiectasis (ASPEN)


About this study

The purpose 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.The study protocol allows for children ages 12-18 years to be enrolled; however, Mayo Clinic will not be enrolling any subjects <18 years old.


Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

11. Received any live attenuated vaccine within 4 weeks prior to the first administration
of brensocatib.

12. Suffering an exacerbation 4 weeks before Screening or during the Screening period.

13. 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.

14. Participated in any other interventional clinical studies within 3 months before
Screening Visit.

15. History of alcohol or drug abuse within 6 months prior to the Screening Visit.

16. Is the Investigator or any Sub-Investigator, research assistant, pharmacist, study
coordinator, other staff or relative thereof directly involved in the conduct of the

17. Known history of hypersensitivity to brensocatib or any of its excipients.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 2/1/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Timothy Aksamit, M.D.

Closed-enrolling by invitation

What is this? (?)
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Kayla MacDonald

(507) 538-0595


More information


Publications are currently not available

Mayo Clinic Footer