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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
Sponsor:
Information provided by (Responsible Party):
Don Sin, University of British Columbia

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Prednisone Phase 4

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
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

Resource links provided by the National Library of Medicine

Drug Information available for: Prednisone

Arm Intervention/treatment
Experimental: Prednisone Group
30mg of prednisone PO (orally) everyday for 5 days.
Drug: Prednisone
Administration of prednisone to determine the effect on whole blood gene expression.
Other Names:
  • Deltasone
  • Orasone
  • Prednicen-M
  • Liquid Pred

No Intervention: Control Group
no treatment



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Donald D Sin, MD, MPH University of British Columbia, St. Paul's Hospital, James Hogg Research Centre

Publications:
Global Initiative for Chronic Obstructive Lung Disease, Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease (Updated 2009). http://www.goldcopd.com/Guidelineitem.asp?l1=2&l2=1&intId=2003.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Don Sin, Dr. Don Sin, University of British Columbia
ClinicalTrials.gov Identifier: NCT02534402     History of Changes
Other Study ID Numbers: H15-01147
First Posted: August 27, 2015    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Don Sin, University of British Columbia:
Biomarkers
Genomics
Prednisone
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Prednisone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents