Evaluation of Airway Gene Expression in COPD and Controlled Populations
Recruitment status was Recruiting
|First Received Date ICMJE||December 11, 2007|
|Last Updated Date||December 11, 2007|
|Start Date ICMJE||August 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Evaluation of Airway Gene Expression in COPD and Controlled Populations|
|Official Title ICMJE||Evaluation of Airway Gene Expression in COPD and Controlled Populations|
To explore potential proteins that may be used to develop novel therapies for COPD. This will be accomplished by acquiring material from the lower respiratory tract via endobronchial brushings.
Chronic Obstructive Pulmonary Disease(COPD) is currently the fourth leading cause of death in the United States. COPD is characterized by reduced airflow that is largely irreversible and progressive. Smoking is recognized as the most important cause of COPD contributing up to 80% of the cases. The disease does demonstrate a significant variability in airflow obstruction during the progression of the disease among those who are diagnosed and treated. This is probably due not only to the role of exposure of cigarette smoke and other noxious inhaled particles and gases but also to the individual's varied responses to those exposures.
COPD is characterized by an inflammatory response that does have a number of components that may be present in variable amounts. Recent data suggests that the cigarette exposure may cause several distinct pathophysiological processes that in turn may account for the variability demonstrated in altered lung structure that leads to functional impairment. Current therapies can help with alleviation of symptoms in individuals but not the unaltered course of loss in lung function that frequently leads to respiratory failure and death.
New strategies have been discussed as a means to new therapeutic approaches to altering the course of the disease. The use of genomic and proteomic methodologies offer promise to identify the pathways critical and relevant to the progression of COPD. To date approved medications target only the inflammatory response to the disease.
The study will explore metabolic pathways that could affect the remodeling process associated with the disease. Because of the heterogeneity of COPD, characteristics of the individual as well as between individuals must be identified in more detail. Mechanisms that enable this not only include physiological characterization by the current prescribed interventions but also imaging data which provides such ability to quantify airway wall thickness as well as via DNA that will be collected and save in order to gain a better understanding between the methodologies as they relate to the characterization of COPD. Currently, there may be a common understanding of how a particular drug affects a detailed molecular mechanism, however frequently it is not known why. The purpose of this study is to assist in discovery of the why.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Biospecimen||Retention: Samples With DNA
Genetic testing involves identification of potential proteins and biomarkers produced from the DNA and RNA analysis. Included are MMP12 and MMP9, Nrf-2 gene, heme oxygenases, glutathione, sythesizing enzymes, thioredoxin reductase, NADPH dependent quinone reductase 1 as well as certain p450 members.
|Sampling Method||Non-Probability Sample|
Males or non-pregnant, non-nursing females who are of non-childbearing potential between the ages of 45 and 70 years of age and who may be either life long non smokers, smokers who do not demonstrate symptoms of COPD and smokers who do demonstrate symptoms of COPD
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||30|
|Estimated Completion Date||September 2008|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||45 Years to 70 Years|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Not Provided|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00571792|
|Other Study ID Numbers ICMJE||406-05|
|Has Data Monitoring Committee||No|
|Responsible Party||Stephen I. Rennard, MD, University of Nebraska Medical Center|
|Study Sponsor ICMJE||University of Nebraska|
|Collaborators ICMJE||Wyeth is now a wholly owned subsidiary of Pfizer|
|Information Provided By||University of Nebraska|
|Verification Date||December 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP