NCT00281229

Brief Summary

The purpose of this study is to determine whether the lungs of individuals with chronic obstructive pulmonary disease (COPD) contain resident memory T lymphocytes that can produce a combination of cytokines that induce the symptoms of an acute exacerbation of COPD (AE-COPD). Specifically, the study will determine cell-surface receptors of lung T cells in comparison with blood T cells from the same subject, and will examine anti-CD3-activated blood or lung T cells for interleukin (IL)-6 and interferon-gamma production in response to IL-18, and for IL-17A production in response to recombinant IL-23.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
481

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2005

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 24, 2006

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

June 17, 2019

Status Verified

January 1, 2016

Enrollment Period

9 years

First QC Date

January 20, 2006

Last Update Submit

June 13, 2019

Conditions

Pulmonary Disease, Chronic ObstructiveLung Diseases, Obstructive

Keywords

Chronic Obstructive Pulmonary DiseaseCOPD

Outcome Measures

Primary Outcomes (1)

  • phenotype and in vitro functions of lung lymphocytes

    within 3 days of surgery

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects undergoing clinically indicated lung resections.

You may qualify if:

  • Diagnosis of COPD AND underwent lung resection for malignancy OR lung volume reduction surgery OR lung transplantation OR lung resection for nodules and masses

You may not qualify if:

  • Mental incompetence or active psychiatric illness
  • Currently using more than 20 mg/day of Prednisone
  • Asthma as primary clinical pulmonary diagnosis
  • Cystic fibrosis
  • Clinically significant bronchiectasis
  • Other inflammatory or fibrotic lung disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Michigan at Ann Arbor

Ann Arbor, Michigan, 48105, United States

Location

VA Ann Arbor Healthcare System

Ann Arbor, Michigan, 48105, United States

Location

Related Publications (10)

  • 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: 17640964BACKGROUND

  • 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: 17878463BACKGROUND

  • Curtis JL. Cell-mediated adaptive immune defense of the lungs. Proc Am Thorac Soc. 2005;2(5):412-6. doi: 10.1513/pats.200507-070JS.

    PMID: 16322591BACKGROUND

  • Freeman CM, Stolberg VR, Crudgington S, Martinez FJ, Han MK, Chensue SW, Arenberg DA, Meldrum CA, McCloskey L, Curtis JL. Human CD56+ cytotoxic lung lymphocytes kill autologous lung cells in chronic obstructive pulmonary disease. PLoS One. 2014 Jul 31;9(7):e103840. doi: 10.1371/journal.pone.0103840. eCollection 2014.

    PMID: 25078269RESULT

  • Freeman CM, McCubbrey AL, Crudgington S, Nelson J, Martinez FJ, Han MK, Washko GR Jr, Chensue SW, Arenberg DA, Meldrum CA, McCloskey L, Curtis JL. Basal gene expression by lung CD4+ T cells in chronic obstructive pulmonary disease identifies independent molecular correlates of airflow obstruction and emphysema extent. PLoS One. 2014 May 7;9(5):e96421. doi: 10.1371/journal.pone.0096421. eCollection 2014.

    PMID: 24805101RESULT

  • Freeman CM, Martinez FJ, Han MK, Washko GR Jr, McCubbrey AL, Chensue SW, Arenberg DA, Meldrum CA, McCloskey L, Curtis JL. Lung CD8+ T cells in COPD have increased expression of bacterial TLRs. Respir Res. 2013 Feb 1;14(1):13. doi: 10.1186/1465-9921-14-13.

    PMID: 23374856RESULT

  • 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: 20427767RESULT

  • 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: 19729666RESULT

  • 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: 26243260RESULT

  • Todt JC, Freeman CM, Brown JP, Sonstein J, Ames TM, McCubbrey AL, Martinez FJ, Chensue SW, Beck JM, Curtis JL. Smoking decreases the response of human lung macrophages to double-stranded RNA by reducing TLR3 expression. Respir Res. 2013 Mar 9;14(1):33. doi: 10.1186/1465-9921-14-33.

    PMID: 23497334DERIVED

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveLung Diseases, Obstructive

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jeffrey L. Curtis, M.D

    University of Michigan at Ann Arbor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Internal Medicine

Study Record Dates

First Submitted

January 20, 2006

First Posted

January 24, 2006

Study Start

September 1, 2005

Primary Completion

September 1, 2014

Study Completion

January 1, 2015

Last Updated

June 17, 2019

Record last verified: 2016-01

Locations

US(2)