NCT00281190

Brief Summary

The purpose of this study is to determine whether the alveolar macrophages (AMø) of patients with chronic obstructive pulmonary disease (COPD ) show abnormal responsiveness to bacterial and viral products, relative to smokers with normal pulmonary function. Participation in this study will be offered to patients already scheduled to undergo a bronchoscopy for clinical indications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

December 16, 2014

Status Verified

December 1, 2014

Enrollment Period

9.1 years

First QC Date

January 20, 2006

Last Update Submit

December 12, 2014

Conditions

Pulmonary Disease, Chronic ObstructiveLung Diseases, Obstructive

Keywords

Chronic Obstructive Pulmonary DiseaseCOPD

Outcome Measures

Primary Outcomes (1)

  • alveolar macrophage functions in vitro

    day of bronchoscopy

Study Arms (2)

Healthy smokers

Smokers with normal pulmonary function

Procedure: Blood drawingProcedure: Bronchoalveolar lavage during indicated bronchoscopy

COPD patients

COPD patients

Procedure: Blood drawingProcedure: Bronchoalveolar lavage during indicated bronchoscopy

Interventions

Blood drawingPROCEDURE

blood will be drawn at the time of starting the intravenous (IV) line for the procedure.

COPD patientsHealthy smokers
Bronchoalveolar lavage during indicated bronchoscopyPROCEDURE

A small amount of liquid will be introduced and immediately sucked back out of portions of the lung, and the cells that are recovered will be analyzed in the laboratory. All test will be solely for research, and there will be no results reported to the subject from that fluid.

Also known as: BAL
COPD patientsHealthy smokers

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Smokers with COPD or smokers with normal pulmonary function will be recruited from among subjects scheduled to undergo bronchoscopy for clinical indications.

You may qualify if:

  • Diagnosis of COPD and/or chronic bronchitis (study group, following American Thoracic Society guidelines)
  • Willingness to participate in follow-up studies defined in the protocol
  • Ability to give informed consent
  • Already undergoing clinically indicated bronchoscopy

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan at Ann Arbor

Ann Arbor, Michigan, 48105, United States

Location

Related Publications (7)

  • 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

  • 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: 20427767BACKGROUND

  • 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: 19729666BACKGROUND

  • Curtis JL, Todt JC, Hu B, Osterholzer JJ, Freeman CM. Tyro3 receptor tyrosine kinases in the heterogeneity of apoptotic cell uptake. Front Biosci (Landmark Ed). 2009 Jan 1;14(7):2631-46. doi: 10.2741/3401.

    PMID: 19273223BACKGROUND

  • Punturieri A, Copper P, Polak T, Christensen PJ, Curtis JL. Conserved nontypeable Haemophilus influenzae-derived TLR2-binding lipopeptides synergize with IFN-beta to increase cytokine production by resident murine and human alveolar macrophages. J Immunol. 2006 Jul 1;177(1):673-80. doi: 10.4049/jimmunol.177.1.673.

    PMID: 16785566RESULT

  • Erb-Downward JR, Thompson DL, Han MK, Freeman CM, McCloskey L, Schmidt LA, Young VB, Toews GB, Curtis JL, Sundaram B, Martinez FJ, Huffnagle GB. Analysis of the lung microbiome in the "healthy" smoker and in COPD. PLoS One. 2011 Feb 22;6(2):e16384. doi: 10.1371/journal.pone.0016384.

    PMID: 21364979RESULT

  • 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: 23497334RESULT

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveLung Diseases, Obstructive

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Jeffrey L. Curtis

    University of Michigan at Ann Arbor

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
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

October 1, 2014

Study Completion

October 1, 2014

Last Updated

December 16, 2014

Record last verified: 2014-12

Locations

US(1)