Phase 2
N=256
Assessment of INS1007 in Participants With Non-Cystic Fibrosis Bronchiectasis
Non-Cystic Fibrosis Bronchiectasis
Bottom Line
View on ClinicalTrials.gov: NCT03218917 ↗Enrolled (actual)
256
Serious AEs
15.7%
Results posted
Feb 2023
Primary outcome: Primary: Time to the First Pulmonary Exacerbation Over 24-Week Treatment Period — NA; NA; 189.0 days — p== 0.014
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Brensocatib 10 mg (Drug); Brensocatib 25 mg (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Insmed Incorporated
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to the First Pulmonary Exacerbation Over 24-Week Treatment Period |
NA; NA; 189.0 | = 0.014 sig |
| SECONDARY Change From Baseline in Quality of Life Questionnaire - Bronchiectasis (QOL-B) Respiratory Symptoms Domain Score Over 24 Week Treatment Period |
3.8; 5.9; 5.7 | — |
| SECONDARY Change From Screening in Post-Bronchodilator Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Over 24-Week Treatment Period |
-0.3; -0.3; -1.8 | — |
| SECONDARY Change From Baseline in Concentration of Active Neutrophil Elastase (NE) in Sputum |
-2.928; -4.117; -1.409 | — |
| SECONDARY Number of Participants Who Experienced a Pulmonary Exacerbation |
26; 29; 42 | — |
Summary
The purpose of the study is to evaluate if INS1007 can reduce pulmonary exacerbations over a 24-week treatment period in participants with non-cystic fibrosis bronchiectasis.
Eligibility Criteria
Inclusion Criteria
- Clinical history consistent with NCFBE (cough, chronic sputum production and/or recurrent respiratory infections)
- Are current sputum producers with a history of chronic expectoration and able to provide a sputum sample during Screening
- Have at least 2 documented pulmonary exacerbations in the past 12 months before Screening
Exclusion Criteria
- Have a primary diagnosis of chronic obstructive pulmonary disease (COPD) or asthma
- Have bronchiectasis due to cystic fibrosis (CF), hypogammaglobulinemia, common variable immunodeficiency, or alpha1-antitrypsin deficiency
- Are current smokers
- Are currently being treated for a nontuberculous mycobacterial lung infection, allergic bronchopulmonary aspergillosis, or tuberculosis
- Have any acute infections, (including respiratory infections)
Data sourced from ClinicalTrials.gov (NCT03218917). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.