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OpenTrials
Completed

NCT Number: NCT01337661

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

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).

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

Dublin, 15, Ireland

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Identification of how inflammatory pathways differ in COPD subjects

    Time frame: 6 weeks

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

Secondary outcomes

  1. Biomarker Sample Repository

    Time frame: 6 weeks

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

Sponsors and collaborators

Lead sponsor

MedImmune LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 19, 2011
Registry last updated
Aug 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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