A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis (ASPEN)
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|ClinicalTrials.gov Identifier: NCT04594369|
Recruitment Status : Recruiting
First Posted : October 20, 2020
Last Update Posted : April 26, 2021
|Condition or disease||Intervention/treatment||Phase|
|Non-Cystic Fibrosis Bronchiectasis||Drug: Brensocatib 10 mg Drug: Brensocatib 25 mg Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1620 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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|
|Actual Study Start Date :||December 1, 2020|
|Estimated Primary Completion Date :||March 2024|
|Estimated Study Completion Date :||March 2024|
Experimental: Brensocatib 10 mg
Participants will receive brensocatib 10 mg once daily, for 52 weeks.
Drug: Brensocatib 10 mg
Other Name: INS1007
Experimental: Brensocatib 25 mg
Participants will receive brensocatib 25 mg once daily, for 52 weeks.
Drug: Brensocatib 25 mg
Other Name: INS1007
Placebo Comparator: Placebo
Participants will receive a brensocatib-matching placebo once daily.
Brensocatib-matching oral tablet.
- Rate of Pulmonary Exacerbations (PEs) [ Time Frame: 52 Weeks ]
- Time to First Pulmonary Exacerbation (PE) [ Time Frame: 52 Weeks ]
- Percentage of Participants who are Pulmonary Exacerbation (PE) Free [ Time Frame: 52 Weeks ]
- Change from Baseline in Postbronchodilator Forced Expiratory Volume in 1 second (FEV1) Measurements [ Time Frame: Baseline to Week 52 ]
- Rate of Severe Pulmonary Exacerbations (PEs) [ Time Frame: 52 Weeks ]
- Change from Baseline to Week 52 in Quality of Life Questionnaire - Bronchiectasis (QOL-B) Respiratory Symptoms Domain Score [ Time Frame: Baseline to Week 52 ]
- Incidence and severity of treatment-emergent adverse events [ Time Frame: Up to Week 56 ]
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): NCT04594369
|Contact: Insmed Medical Information||844-4-INSMEDfirstname.lastname@example.org|