Non-Cystic Fibrosis Bronchiectasis
Conditions
Keywords
Cathepsin G, CKD-EPI, NCFBE
Brief summary
The purpose of this study is to allow early access to brensocatib for participants with non-cystic fibrosis bronchiectasis (NCFBE) who have successfully completed the INS1007301 ASPEN Clinical trial.
Detailed description
Participants will receive brensocatib 10 mg, oral tablets, once daily.
Interventions
DRUGBrensocatib
Brensocatib tablets
Sponsors
Insmed Incorporated
Eligibility
Sex/Gender
ALL
Age
12 Years to 85 Years
Inclusion criteria
* Participant had agreed to provide their informed consent to participate per local requirements. * Participant had successfully completed Clinical Trial INS 1007-301 ASPEN, including the End of study Visit 12 prior to receiving treatment. * Requests for Post-Trial access for brensocatib had come from ASPEN investigator. * Had received brensocatib treatment.
Exclusion criteria
* Participant had experienced a serious adverse event deemed to be related to brensocatib during the study and required permanent participant is continuation. * The participant is immunocompromised or chronically treated with any investigational or commercialized immunomodulatory agent that is directed to any component of the adaptive or innate immune systems. Note: The use of any immunomodulatory agents (including but not limited to: bortezomib, ixazomib, thalidomide, cyclophosphamide, mycophenolate, Janus kinase inhibitors, IFN-γ, and azathioprine) is prohibited during the program. * The participant had undergone continuous use of high dose non-steroidal anti-inflammatory drugs. * The participant had undergone chronic use of systemic steroids for any chronic condition, except steroids with topical anti-inflammatory activities (ie, oral budesonide). * Participant had planned to receive live attenuated vaccines during the program (treatment must be postponed until 4 weeks after the last dose of drug). * Participant had planned to use investigational drugs.
Outcome results
None listed