EUCTR2017-002533-32-ES
Active, not recruiting
Phase 1
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- on-Cystic Fibrosis Bronchiectasis
- Sponsor
- Insmed Incorporated
- Enrollment
- 240
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects who have given their signed, informed consent, are male or female between 18 and 85 years of age (inclusive) with a body mass index \> 18\.5 at Screening (Visit 1\) and have a clinical history consistent with NCFBE will be eligible for enrollment in the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 96
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 144
Exclusion Criteria
- •Subjects who have a primary diagnosis of chronic obstructive pulmonary disease or asthma, have bronchiectasis due to cystic fibrosis, hypogammaglobulinemia, common variable immunodeficiency, or a1\-antitrypsin deficiency, are current smokers as defined per Centers for Disease Control and Prevention criteria, or currently being treated for a nontuberculous mycobacterial lung infection, allergic bronchopulmonary aspergillosis, or tuberculosis will not be eligible for enrollment in the study.
Outcomes
Primary Outcomes
Not specified
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