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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Clinical history consistent with NCFBE (cough, chronic sputum production and/or recurrent respiratory infections) 2. Are current sputum producers with a history of chronic expectoration and able to provide a sputum sample during Screening 3. Have at least 2 documented pulmonary exacerbations in the past 12 months before Screening

Exclusion Criteria

  1. Have a primary diagnosis of chronic obstructive pulmonary disease (COPD) or asthma 2. Have bronchiectasis due to cystic fibrosis (CF), hypogammaglobulinemia, common variable immunodeficiency, or alpha1-antitrypsin deficiency 3. Are current smokers 4. Are currently being treated for a nontuberculous mycobacterial lung infection, allergic bronchopulmonary aspergillosis, or tuberculosis 5. Have any acute infections, (including respiratory infections)

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Brensocatib 10 mg 		Participants received brensocatib 10 mg once daily (QD) before breakfast, for 24 weeks.
  • Drug: Brensocatib 10 mg
    Administered once per day for 24 weeks
Experimental
Brensocatib 25 mg 		Participants received brensocatib 25 mg QD before breakfast, for 24 weeks.
  • Drug: Brensocatib 25 mg
    Administered once per day for 24 weeks
Placebo Comparator
Placebo 		Participants received the matching placebo QD before breakfast, for 24 weeks.
  • Drug: Placebo
    Administered once per day for 24 weeks

More Details

Status
Completed
Sponsor
Insmed Incorporated

Study Contact

Detailed Description

Phase 2 randomized, double-blind, placebo-controlled, parallel-group, multicenter, multi-national study to assess the efficacy, safety and tolerability, and pharmacokinetics (PK) of INS1007 administered once daily for 24 weeks in participants with non-cystic fibrosis bronchiectasis (NCFBE).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.