Prednisone Administration in Quiescent COPD Patients to Determine the Effect on Gene Expression

Study Overview
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Brief Summary
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In this study, prednisone dose, day/time administration will be controlled in a stable COPD patient population to determine its effect on peripheral whole blood gene expression. This data has never been collected in a COPD population using the investigators' chosen platform for gene expression (Affymetrix Human Gene 1.1 ST). Conducting this experiment is essential for achieving the broader aims of an already existing and related study titled Clinical Implementation and Outcomes Evaluation of Blood-Based Biomarkers for COPD Management study. As part of this existing study, blood is being collected from hospitalized and non-hospitalized COPD patients in order to develop a blood-based biomarker test for the diagnosis and prediction of acute exacerbation of COPD (AECOPD). The majority of these patients were administered prednisone as part of standard care for the treatment of AECOPD. As such, the effect of prednisone on gene expression needs to be ruled out.

Detailed Description
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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.

Official Title
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Clinical Implementation and Outcomes Evaluation of Blood-Based Biomarkers for COPD Management: COPD Prednisone Sub-Study

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: Prednisone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants diagnosed with COPD Exclusion Criteria: Participants currently taking prednisone Participants who received prednisone within the last 2 weeks Participants who were hospitalized in the last 2 weeks for COPD or a related respiratory condition

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prednisone Group<br>30mg of prednisone PO (orally) everyday for 5 days. | Drug: Prednisone<br>* Administration of prednisone to determine the effect on whole blood gene expression.<br>* Other names: Liquid Pred;|
| No Intervention: Control Group<br>no treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of prednisone on peripheral whole blood gene expression | 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. | Period of 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biomarkers, Genomics, Prednisone