Prednisone Administration in Quiescent COPD Patients to Determine the Effect on Gene Expression
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|ClinicalTrials.gov Identifier: NCT02534402|
Recruitment Status : Active, not recruiting
First Posted : August 27, 2015
Last Update Posted : June 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Drug: Prednisone||Phase 4|
The course of COPD is frequently complicated by periods of exacerbation (worsening symptoms) related to infections, pollution, other diseases or poor management of disease. These periods result in urgent visits to physician offices or emergency rooms accounting for the leading cause of hospitalizations. In terms of patient care, physicians lack objective measurements to accurately risk-stratify patients and monitor the effectiveness of interventions provided for their patients. Regrettably, there are no blood tests that can predict who will and will not get AECOPD to require hospitalization. Additionally, current therapies for COPD are only modestly effective in reducing exacerbations. A major challenge in COPD drug development and patient care is the lack of markers, surrogate or otherwise, that can be used to predict outcomes such as hospitalization or mortality.
These critical barriers to drug development and improved patient care could be addressed by the development and clinical implementation of diagnostic and predictive AECOPD biomarkers. This is the aim of an already existing and related study titled "Clinical Implementation and Outcomes Evaluation of Blood-Based Biomarkers for COPD Management study". This study has been enrolling COPD patients since July 2012. The majority of the the study patients were on prednisone at the time of blood collection and at enrollment.
The analyses of publicly available datasets make it abundantly clear that prednisone has important and wide-ranging effects on peripheral whole blood gene expression. These data are insufficient, however, because they cannot inform disease specific effects on gene expression. In addition, because these studies were carried out using a different gene expression platform, they cannot be used to estimate the probeset-specific prednisone effects.
Therefore, the investigators need to ensure that the gene expression associated with AECOPD is not in fact a result of the drug effect. Conducting this study will help us answer this question.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Clinical Implementation and Outcomes Evaluation of Blood-Based Biomarkers for COPD Management: COPD Prednisone Sub-Study|
|Study Start Date :||August 2015|
|Actual Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2019|
Experimental: Prednisone Group
30mg of prednisone PO (orally) everyday for 5 days.
Administration of prednisone to determine the effect on whole blood gene expression.
No Intervention: Control Group
- Effect of prednisone on peripheral whole blood gene expression [ Time Frame: Period of 5 days ]Effect of prednisone on peripheral whole blood gene expression of stable COPD patients, assayed using Affymetrix Human Gene 1.1 ST microarrays. This outcome measure will be assessed at each blood draw.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02534402
|Canada, British Columbia|
|St. Paul's Hospital|
|Vancouver, British Columbia, Canada, V6Z 1Y6|
|Principal Investigator:||Donald D Sin, MD, MPH||University of British Columbia, St. Paul's Hospital, James Hogg Research Centre|