Assessment of INS1007 in Subjects With Non-Cystic Fibrosis Bronchiectasis

• Status: Completed
• Trial end date: 2019-12-12
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Insmed Incorporated

Criteria

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)