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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-02-29

Brief Summary

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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

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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).

Conditions

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Chronic Obstructive Pulmonary Disease

Keywords

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Chronic Obstructive Pulmonary Disease COPD Acute Exacerbation of COPD AECOPD

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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COPD subjects

Adult male and female subjects with COPD

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rene van der Merwe, MBChB, MFPM

Role: STUDY_DIRECTOR

MedImmune Ltd

Prof. Connor Burke

Role: PRINCIPAL_INVESTIGATOR

BCF Diagnostics

Locations

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Research Site

Dublin, , Ireland

Site Status

Countries

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Ireland

Other Identifiers

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CD-RI-INDP-1048

Identifier Type: -

Identifier Source: org_study_id