A Study of the Inflammatory Pathways Associated With Chronic Obstructive Pulmonary Disease Exacerbations
This study has been completed.
Sponsor:
MedImmune LLC
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
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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
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 Respiration Disorders Pulmonary Disease, Chronic Obstructive Disease Progression |
Lung Diseases, Obstructive Respiratory Tract Diseases Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013