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

  • STATUS
    Recruiting
  • End date
    Mar 31, 2024
  • participants needed
    1620
  • sponsor
    Insmed Incorporated
Updated on 15 September 2021
Investigator
Insmed Medical Information
Primary Contact
USA036 (5.0 mi away) Contact
+283 other location

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.

Details
Condition Non Cystic Fibrosis Bronchiectasis
Treatment Placebo, Brensocatib 10 mg, Brensocatib 25 mg
Clinical Study IdentifierNCT04594369
SponsorInsmed Incorporated
Last Modified on15 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Provide their signed study informed consent to participate
Clinical history consistent with non-cystic fibrosis bronchiectasis (cough, chronic sputum production and/or recurrent respiratory infections) that is confirmed by chest computerized tomography (CT) scan
At least 2 pulmonary exacerbations 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
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 subjects 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
Previously participated in a clinical trial of brensocatib
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
Have compliance issues with completion of electronic diary entries (<75%) during the Screening Period AND in the opinion of the Investigator, compliance is unlikely to improve during the study
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
Clear my responses

How to participate?

Step 1 Connect with a site
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
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

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

Loading...

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 • 

 • 

Private

Reply by • Private
Loading...

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.
Loading...

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