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DDT COA #000072: Constant Work Rate Exercise

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
In transition to 507 process 

Requestor(s)
COPD Biomarker Qualification Consortium (CBQC)

Contact(s)
Debora Merrill

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

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