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
COPD Patients

COA Type
PerfO

Qualification Stage
Letter of Intent-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