An Expanded Access Study to Assess Brensocatib for Participants With Non-Cystic Fibrosis Bronchiectasis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05344508|
Expanded Access Status : Available
First Posted : April 25, 2022
Last Update Posted : January 12, 2023
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|Condition or disease||Intervention/treatment|
|Non-Cystic Fibrosis Bronchiectasis||Drug: Brensocatib|
|Study Type :||Expanded Access|
|Expanded Access Type :||Treatment IND/Protocol|
|See clinical trials of the intervention/treatment in this expanded access record.|
|Official Title:||Brensocatib in Patients With Non-Cystic Fibrosis Bronchiectasis|
- Drug: Brensocatib
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 85 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05344508
|Contact: Insmed Medical Informationemail@example.com|
|Responsible Party:||Insmed Incorporated|
|Other Study ID Numbers:||
|First Posted:||April 25, 2022 Key Record Dates|
|Last Update Posted:||January 12, 2023|
|Last Verified:||January 2023|
Respiratory Tract Diseases