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

NCT02534402 | Unknown Phase 4

• 1 other identifier: H15-01147
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Biomarkers; Genomics; Prednisone

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Prednisone Group

EXPERIMENTAL

30mg of prednisone PO (orally) everyday for 5 days.

Drug: Prednisone

Control Group

NO INTERVENTION

no treatment

Interventions

Prednisone DRUG

Administration of prednisone to determine the effect on whole blood gene expression.

Also known as: Deltasone, Orasone, Prednicen-M, Liquid Pred

Prednisone Group

Eligibility Criteria

• Age: 19 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants diagnosed with COPD

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Related Publications (10)

• 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.

  BACKGROUND

• Chapman KR, Bourbeau J, Rance L. The burden of COPD in Canada: results from the Confronting COPD survey. Respir Med. 2003 Mar;97 Suppl C:S23-31. doi: 10.1016/s0954-6111(03)80022-7.

  PMID: 12647940 BACKGROUND

• Mittmann N, Kuramoto L, Seung SJ, Haddon JM, Bradley-Kennedy C, Fitzgerald JM. The cost of moderate and severe COPD exacerbations to the Canadian healthcare system. Respir Med. 2008 Mar;102(3):413-21. doi: 10.1016/j.rmed.2007.10.010. Epub 2007 Dec 20.

  PMID: 18086519 BACKGROUND

• Murray CJ, Lopez AD. Alternative projections of mortality and disability by cause 1990-2020: Global Burden of Disease Study. Lancet. 1997 May 24;349(9064):1498-504. doi: 10.1016/S0140-6736(96)07492-2.

  PMID: 9167458 BACKGROUND

• Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006 Nov;3(11):e442. doi: 10.1371/journal.pmed.0030442.

  PMID: 17132052 BACKGROUND

• Sin DD, McAlister FA, Man SF, Anthonisen NR. Contemporary management of chronic obstructive pulmonary disease: scientific review. JAMA. 2003 Nov 5;290(17):2301-12. doi: 10.1001/jama.290.17.2301.

  PMID: 14600189 BACKGROUND

• Malhotra S, Man SF, Sin DD. Emerging drugs for the treatment of chronic obstructive pulmonary disease. Expert Opin Emerg Drugs. 2006 May;11(2):275-91. doi: 10.1517/14728214.11.2.275.

  PMID: 16634702 BACKGROUND

• Vestbo J, Anderson W, Coxson HO, Crim C, Dawber F, Edwards L, Hagan G, Knobil K, Lomas DA, MacNee W, Silverman EK, Tal-Singer R; ECLIPSE investigators. Evaluation of COPD Longitudinally to Identify Predictive Surrogate End-points (ECLIPSE). Eur Respir J. 2008 Apr;31(4):869-73. doi: 10.1183/09031936.00111707. Epub 2008 Jan 23.

  PMID: 18216052 BACKGROUND

• Kuzyk MA, Smith D, Yang J, Cross TJ, Jackson AM, Hardie DB, Anderson NL, Borchers CH. Multiple reaction monitoring-based, multiplexed, absolute quantitation of 45 proteins in human plasma. Mol Cell Proteomics. 2009 Aug;8(8):1860-77. doi: 10.1074/mcp.M800540-MCP200. Epub 2009 May 1.

  PMID: 19411661 BACKGROUND

• Takiguchi H, Chen V, Obeidat M, Hollander Z, FitzGerald JM, McManus BM, Ng RT, Sin DD. Effect of short-term oral prednisone therapy on blood gene expression: a randomised controlled clinical trial. Respir Res. 2019 Aug 5;20(1):176. doi: 10.1186/s12931-019-1147-2.

  PMID: 31382977 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Donald D Sin, MD, MPH

  University of British Columbia, St. Paul's Hospital, James Hogg Research Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Don Sin

Study Record Dates

• First Submitted: August 26, 2015
• First Posted: August 27, 2015
• Study Start: August 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2021
• Last Updated: April 30, 2021

Record last verified: 2021-04

Locations

CA (1)