Assessment of INS1007 in Subjects With Non-Cystic Fibrosis Bronchiectasis



Status:Recruiting
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 85
Updated:3/31/2019
Start Date:December 1, 2017
End Date:June 2020
Contact:Tomoko Shibata
Email:tomoko.shibata@insmed.com
Phone:+1.908.947.2821

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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).

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)
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Sarasota, Florida 34239
Principal Investigator: Rabin Loutfi
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1720 2nd Ave S
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5801 South Ellis Avenue
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3451 Walnut St
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