Qualified Clinical Outcome Assessments (COA)
Office of Infectious Diseases (OID)
Division of Anti-Infectives (DAI)

DDT COA Number
DDT COA #000003

Instrument Name
Exacerbations of Chronic Pulmonary Disease Tool (EXACT)

Disease/Condition
Acute Bacterial Exacerbation of Chronic Bronchitis in patients with Chronic Obstructive Pulmonary Disease (ABECB-COPD)

Concept of Interest
Symptoms of ABECB-COPD

Context of Use
Outpatients with ABECB-COPD who meet the clinical trial entry criteria as described in the FDA Guidance: Acute Bacterial Exacerbations of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonary Disease: Developing Antimicrobial Drugs for Treatment.             

COA Type
PRO

Requestor(s)
Evidera

Contact(s)
Nancy Leidy

Qualification Date
January 9, 2014
Qualification Statement*

Qualification Supporting Information

Study Endpoints and Labeling Development (SEALD) Review
Clinical Review
Biostatistics Review

*Under review prior to the passage of the 21st Century Cures Act

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