DDT COA #000125: Endurance Shuttle Walking Test (ESWT)
Clinical Outcome Assessments (COA) Qualification Submissions
Office of Immunology and Inflammation (OII)
Division of Pulmonary, Allergy, and Critical Care (DPACC)
DDT COA Number
DDT COA #000125
Instrument Name
Endurance Shuttle Walking Test (ESWT)
Disease/Condition
Chronic Obstructive Pulmonary Disease (COPD)
Concept of Interest
Walking endurance
Context of Use
Patients with COPD
COA Type
PerfO
Qualification Stage
Qualification Plan - Not Accepted
Requestor(s)
COPD Biomarker Qualification Consortium (CBQC)
Contact(s)
Debora Merrill
Date Accepted into CDER’s COA Qualification Program
May 14, 2015
Submission and Regulatory Correspondence History
| Qualification Submission | Date | FDA Submission Decision & Recommendations | Date |
|---|---|---|---|
| Qualification Plan | 5/4/20 | FDA Response (Not Accepted) | 10/20/20 |