DDT COA #000003: Exacerbations of Chronic Pulmonary Disease Tool (EXACT)
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