Assessment of INS1007 in Subjects With Non-Cystic Fibrosis Bronchiectasis

  • Interventional
  • Recruiting
  • NCT03218917
Eligibility Details Visit Clinicaltrials.gov

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

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.

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).

Gender
All

Age Group
18 Years to 85 Years

Accepting 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)
  • Non-Cystic Fibrosis Bronchiectasis

At a Glance

National Government IDNCT03218917

IRB#IRB17-1710

Lead SponsorInsmed Incorporated

Lead PhysicianPamela Mcshane

Collaborator(s)N/A

EligibilityAll
18 Years to 85 Years
Recruiting