Innate and Adaptive Immunity in Individuals Experiencing Chronic Obstructive Pulmonary Disease Exacerbations

NCT00281216 | Completed

• 2 other identifiers: 1324R01HL082480
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether there is a statistical association between the changes from baseline in the levels of two cytokines interleukin (IL)-17A and IL-6 in the sputum of patients with chronic obstructive pulmonary disease (COPD) and the severity of acute exacerbations of COPD (AE-COPD). These sputum cytokine levels are taken as measures of the adaptive immune response (IL-17A) and the innate immune response (IL-6), respectively. Sputum will be collected either spontaneously or will be obtained by induction; cytokine levels will be measured by ELISA. The primary analysis, comparisons of sputum cytokine levels between clinical states, will be done using random effects modeling.

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases; Lung Diseases, Obstructive

Keywords

Chronic Obstructive Pulmonary Disease; COPD

Outcome Measures

Primary Outcomes (1)

• length of hospital stay

  hospital discharge

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

Recruited from pulmonary and general medicine clinics

You may qualify if:

• Diagnosis of COPD (following American Thoracic Society guidelines) and/or chronic bronchitis
• Forced Expiratory Volume in 1 second of less than 70% predicted value after bronchodilator
• Current or former smokers with more than 20 pack-years
• Daily productive cough for 3 months of the year for 2 consecutive years
• At least one AE-COPD requiring medical attention in each year for the previous 3 years
• Willingness to participate in follow-up studies defined in the protocol

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 (6)

• 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 BACKGROUND

• 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, 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: 23374856 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

• Curtis Laboratory
• COPD Foundation

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum, sputum

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases; Lung Diseases, Obstructive

Condition Hierarchy (Ancestors)

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

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 Division)

Study Record Dates

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

Record last verified: 2016-01

Locations

US (1)