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  6. DDT COA #000072: Constant Work Rate Exercise
  1. Clinical Outcome Assessment (COA) Qualification Program

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

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

Qualification Stage
Qualification Plan - Not Accepted

COPD Biomarker Qualification Consortium (CBQC)

Debora Merrill

Date Accepted into CDER’s COA Qualification Program
May 14, 2015

Submission and Regulatory Correspondence History

Qualification Submission


FDA Submission Decision & Recommendations




Transition Letter to 507 Process


Qualification Plan 5/4/20 FDA Response (Not Accepted) 10/20/20
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