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

An Exploratory Study of the Cellular Inflammatory Mechanisms Associated With Chronic Obstructive Pulmonary Disease Exacerbations

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01337661

Enrollment

Registered

2011-04-19

Start date

2011-04-30

Completion date

2012-02-29

Last updated

2012-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease, COPD, Acute Exacerbation of COPD, AECOPD

Brief summary

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).

Detailed description

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).

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Identification of how inflammatory pathways differ in COPD subjects	6 weeks	Identify how inflammatory pathways differ in subjects with COPD during an acute exacerbation relative to when the disease is stable.

Secondary

Measure	Time frame	Description
Biomarker Sample Repository	6 weeks	Establish a biomarker sample repository to support future target validation for the treatment of subjects with COPD.

Countries

Ireland

Outcome results