DDT COA #000128: Symptom Assessment for Bronchiectasis (SABRE)

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Infectious Diseases (OID)
Division of Anti-Infectives (DAI)

DDT COA Number
DDT COA #000128

Instrument Name
Symptom Assessment for Bronchiectasis (SABRE)

Disease/Condition
Non-cystic fibrosis bronchiectasis (NCFBE)

Concept of Interest
Disease-related symptoms

Context of Use
Adult patients (> 21 years) with NCFBE with or without non-tuberculous mycobacterial (NTM) infection

COA Type
PRO

Qualification Stage
Letter of Intent-Accepted

Requestor(s)
Insmed Inc and Pharmerit International

Contact(s)
Kelly McCarrier
Daniel Serrano

Date Accepted into CDER’s COA Qualification Program
April 28, 2020

Submission and Regulatory Correspondence History

Qualification Submission	Date	FDA Submission Decision & Recommendations	Date
Letter of Intent	2/26/20	FDA Response (Accepted)	4/28/20