Plasma Fibrinogen as a Biomarker for Mortality and Hospitalized Exacerbations in People with COPD.

ABSTRACT:

Background

In 2010 the COPD Foundation established the COPD Biomarkers Qualification Consortium (CBQC) as a partnership between the Foundation, the Food and Drug Administration (FDA), and the pharmaceutical industry to pool publicly-funded and industry data to develop innovative tools to facilitate the development and approval of new therapies for COPD. We present data from the initial project seeking regulatory qualification of fibrinogen as a biomarker for the stratification of COPD patients into clinical trials.

Methods

This analysis pooled data from 4 publicly-funded studies and 1 industry study into a common database resulting in 6376 individuals with spirometric evidence of COPD. We used a threshold of 350 mg/dL to determine high vs. low fibrinogen, and d

SUBMITTER: Mannino DM 

PROVIDER: S-EPMC4326107 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature