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DDT COA #000072: Constant Work Rate Exercise

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Drug Evaluation (ODE) II
Division of Pulmonary, Allergy, and Rheumatology Products (DPARP)

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
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

Qualification Submission

Date

FDA Submission Decision & Recommendations

Date

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Transition Letter to 507 Process

8/27/19

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