A Study of the Inflammatory Pathways Associated With Chronic Obstructive Pulmonary Disease Exacerbations

MedImmune LLC26 enrolled

Overview

The purpose of this study is to observe how the inflammatory pathways differ in subjects with chronic obstructive pulmonary disease (COPD) during an acute exacerbation of COPD (AECOPD).

This is an observational study in adult male and female subjects with COPD to collect blood, endobronchial tissues and BAL to investigate the inflammatory genes/pathways associated with AECOPD at the time of exacerbation (ie, active disease) and at 6 weeks later (ie, stable disease).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Chronic Obstructive Pulmonary Disease

Eligibility

Sex: ALLMin age: 40 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Physician-diagnosed acute exacerbations of chronic obstructive pulmonary disease * Current or ex-smoker with a tobacco history of 15 or more pack years * Females of childbearing potential must use birth control for the duration of the study. Exclusion Criteria: * Evidence or history of clinically significant disease * Subjects with asthma * Subjects taking anti-leukotriene medications

Locations (1)

Research Site

Dublin, Ireland

Outcomes

Primary Outcomes

Identification of how inflammatory pathways differ in COPD subjects

Identify how inflammatory pathways differ in subjects with COPD during an acute exacerbation relative to when the disease is stable.

Time frame: 6 weeks

Secondary Outcomes

Biomarker Sample Repository

Establish a biomarker sample repository to support future target validation for the treatment of subjects with COPD.

Time frame: 6 weeks

Data from ClinicalTrials.gov

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