Assessment of INS1007 in Subjects With Non-Cystic Fibrosis Bronchiectasis
Assessment of INS1007 in Subjects With Non-Cystic Fibrosis Bronchiectasis
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).
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)