Summary

for people ages 18-85 (full criteria)
at Sacramento, California and other locations
study started
estimated completion

Description

Summary

The purpose of the study is to evaluate if INS1007 can reduce pulmonary exacerbations over a 24-week treatment period in patients with non-cystic fibrosis bronchiectasis.

Official Title

Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety & Tolerability, and PK of INS1007 Administered Once Daily for 24 Weeks in Subjects With Non-CF Bronchiectasis - The Willow Study

Details

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 subjects with non-cystic fibrosis bronchiectasis (NCFBE).

Keywords

Non-Cystic Fibrosis Bronchiectasis P aeruginosa bronchiectasis active neutrophil elastase Fibrosis INS1007 10 mg oral tablet INS1007 25 mg oral tablet

Eligibility

You can join if…

Open to people ages 18-85

  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

You CAN'T join if...

  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)

Locations

  • UC Davis Medical Center
    Sacramento California 95817 United States
  • Stanford University Medical Center
    Stanford California 94305-5236 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Insmed Incorporated
Links
Sign up for this study
ID
NCT03218917
Phase
Phase 2
Study Type
Interventional
Last Updated