Changes in Cytokine Levels During an Acute Exacerbation of Chronic Obstructive Pulmonary Disease

NCT00281242 | Completed

• 2 other identifiers: 1325R01HL082480
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether there is a statistical association between changes in sputum serial levels of two cytokines, interleukin (IL)-17 and IL-6, during the treatment course of a severe acute exacerbation of chronic obstructive pulmonary disease (AE-COPD) and during the clinical course itself (i.e., rate of recovery or potential complicated course). AE-COPD is defined as an episode requiring emergency room (ER) evaluation.

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive

Keywords

Chronic Obstructive Pulmonary Disease; COPD

Outcome Measures

Primary Outcomes (1)

• biomarker analysis at the time of exacerbation, no clinical outcome

  at each exacerbation

Study Arms (1)

Research subjects

All participants undergo the same testing in this observational trial. There is no randomization, and no interventions other than blood drawing.

Other: blood draw

Interventions

blood draw OTHER

All subjects undergo blood draws at study visits and at the time of COPD exacerbation visits.

Research subjects

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Emergency room and clinics

You may qualify if:

• Diagnosis of COPD (following American Thoracic Society guidelines) and/or chronic bronchitis
• ER visit and/or hospitalization with AE-COPD
• Current or former smokers with more than 20 pack-years
• Willingness to participate in follow-up studies defined in the protocol
• Ability to give informed consent

You may not qualify if:

• Unstable cardiovascular disease
• Other systemic disease in which survival of more than 2 years is unlikely
• Mental incompetence or active psychiatric illness
• Currently taking more than 20 mg/day of Prednisone
• Participation in another experimental protocol within 6 weeks of study entry
• Asthma
• Cystic fibrosis
• Clinically significant bronchiectasis
• Lung cancer
• Other inflammatory or fibrotic lung disease

Sponsors & Collaborators

• University of Michigan: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Michigan at Ann Arbor

Ann Arbor, Michigan, 48105, United States

Location

Related Publications (5)

• Curtis JL, Freeman CM, Hogg JC. The immunopathogenesis of chronic obstructive pulmonary disease: insights from recent research. Proc Am Thorac Soc. 2007 Oct 1;4(7):512-21. doi: 10.1513/pats.200701-002FM.

  PMID: 17878463 BACKGROUND

• Freeman CM, Curtis JL, Chensue SW. CC chemokine receptor 5 and CXC chemokine receptor 6 expression by lung CD8+ cells correlates with chronic obstructive pulmonary disease severity. Am J Pathol. 2007 Sep;171(3):767-76. doi: 10.2353/ajpath.2007.061177. Epub 2007 Jul 19.

  PMID: 17640964 RESULT

• Freeman CM, Han MK, Martinez FJ, Murray S, Liu LX, Chensue SW, Polak TJ, Sonstein J, Todt JC, Ames TM, Arenberg DA, Meldrum CA, Getty C, McCloskey L, Curtis JL. Cytotoxic potential of lung CD8(+) T cells increases with chronic obstructive pulmonary disease severity and with in vitro stimulation by IL-18 or IL-15. J Immunol. 2010 Jun 1;184(11):6504-13. doi: 10.4049/jimmunol.1000006. Epub 2010 Apr 28.

  PMID: 20427767 RESULT

• Freeman CM, Martinez FJ, Han MK, Ames TM, Chensue SW, Todt JC, Arenberg DA, Meldrum CA, Getty C, McCloskey L, Curtis JL. Lung dendritic cell expression of maturation molecules increases with worsening chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2009 Dec 15;180(12):1179-88. doi: 10.1164/rccm.200904-0552OC. Epub 2009 Sep 3.

  PMID: 19729666 RESULT

• Freeman CM, Martinez CH, Todt JC, Martinez FJ, Han MK, Thompson DL, McCloskey L, Curtis JL. Acute exacerbations of chronic obstructive pulmonary disease are associated with decreased CD4+ & CD8+ T cells and increased growth & differentiation factor-15 (GDF-15) in peripheral blood. Respir Res. 2015 Aug 5;16(1):94. doi: 10.1186/s12931-015-0251-1.

  PMID: 26243260 RESULT

Related Links

• COPD Foundation
• Training Grant in Lung Disease
• Graduate Program in Immunology, University of Michigan

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jeffrey L. Curtis

  University of Michigan at Ann Arbor

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine (Pulmonary & Critical Care Medicine)

Study Record Dates

• First Submitted: January 20, 2006
• First Posted: January 24, 2006
• Study Start: September 1, 2005
• Primary Completion: June 1, 2010
• Study Completion: July 1, 2010
• Last Updated: January 29, 2016

Record last verified: 2016-01

Locations

US (1)