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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01337661
First received: April 13, 2011
Last updated: August 27, 2012
Last verified: August 2012
  Purpose

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).


Condition
Chronic Obstructive Pulmonary Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: An Exploratory Study of the Cellular Inflammatory Mechanisms Associated With Chronic Obstructive Pulmonary Disease Exacerbations

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Identification of how inflammatory pathways differ in COPD subjects [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Identify how inflammatory pathways differ in subjects with COPD during an acute exacerbation relative to when the disease is stable.


Secondary Outcome Measures:
  • Biomarker Sample Repository [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Establish a biomarker sample repository to support future target validation for the treatment of subjects with COPD.


Biospecimen Retention:   Samples Without DNA

Blood, Endobronchial tissues and Bronchoalveolar (BAL) samples


Enrollment: 26
Study Start Date: April 2011
Study Completion Date: February 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
COPD subjects
Adult male and female subjects with COPD

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).

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects referred to the hospital clinic with AECOPD

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01337661

Locations
Ireland
Research Site
Dublin, Ireland, 15
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Rene van der Merwe, MBChB, MFPM MedImmune Ltd
Principal Investigator: Prof. Connor Burke BCF Diagnostics
  More Information

Additional Information:
No publications provided

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01337661     History of Changes
Other Study ID Numbers: CD-RI-INDP-1048
Study First Received: April 13, 2011
Last Updated: August 27, 2012
Health Authority: Ireland: Research Ethics Committee

Keywords provided by MedImmune LLC:
Chronic Obstructive Pulmonary Disease
COPD
Acute Exacerbation of COPD
AECOPD

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Disease Progression
Lung Diseases, Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 19, 2014