DDT COA #000072: Constant Work Rate Exercise
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 #000072
Instrument Name
Constant Work Rate Exercise
Disease/Condition
Chronic Obstructive Pulmonary Disease (COPD)
Concept of Interest
Exercise endurance
Context of Use
COPD patients with moderate to very severe lung function impairment:
- Patients diagnosed with COPD
- Post-bronchodilator FEV1/FVC <70%
- Post-bronchodilator FEV1 <80% predicted normal
- Male or female patients, at least 40 years of age
Current or ex-smokers with a smoking history of more than 10 pack-years
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 |
|---|---|---|---|
|
-- |
-- |
8/27/19 |
|
| Qualification Plan | 5/4/20 | FDA Response (Not Accepted) | 10/20/20 |