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Airway Macrophages and Sputum Milieu in Adult Subjects With Airflow Obstruction

This study has been completed.
Sponsor:
Collaborator:
VA Nebraska Western Iowa Health Care System
Information provided by (Responsible Party):
Jill Poole, MD, University of Nebraska
ClinicalTrials.gov Identifier:
NCT00871637
First received: March 26, 2009
Last updated: August 30, 2017
Last verified: August 2017
  Purpose
Airway macrophage impairment is a central feature in the immunopathogenesis of chronic obstructive pulmonary disease, regardless of smoking status.

Condition
Pulmonary Disease, Chronic Obstructive Bronchitis, Chronic Occupational Diseases Tobacco Use Disorder

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Airway Macrophages and Sputum Milieu in Adult Subjects With Airflow Obstruction

Further study details as provided by Jill Poole, MD, University of Nebraska:

Primary Outcome Measures:
  • Determine if airway macrophages from adult subjects with airflow obstruction demonstrate impaired innate immune cell surface marker expression and phagocytic ability compared to healthy controls. [ Time Frame: One year ]

Secondary Outcome Measures:
  • Determine if airway macrophages from adult subjects with airflow obstruction demonstrate impaired cytokine responsiveness compared to healthy controls. [ Time Frame: One year ]
  • Determine if airway macrophage cytokine responsiveness is comparable to whole blood cytokine responsiveness. [ Time Frame: One year ]
  • To determine if airway sputum milieu for potential immunomodulators predict airway macrophage phenotype and function. [ Time Frame: One year ]

Enrollment: 30
Study Start Date: August 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group One
Healthy non-smoking controls
Group Two
Smoking adults with chronic bronchitis/chronic obstructive pulmonary disease
Group Three
Non-smoking adults with chronic bronchitis/chronic obstructive pulmonary disease

Detailed Description:

In the United States, a variety of farming operations can generate significant amounts of dust. Chronic organic dust exposure to workers in this industry can result in several respiratory health conditions including chronic bronchitis, chronic obstructive pulmonary disease (COPD), and exacerbations of asthma. Organic dust is a complex mixture containing particulate matter and microbial-associated components from gram positive and gram negative bacteria. Airway macrophages are key innate immune cells that are rapidly activated by exposure to inhaled toxins and organic dust.

The literature indicates that subjects with tobacco-induced chronic bronchitis/COPD have alveolar macrophages that have impaired function. It has been hypothesized that the impaired lung macrophage function may contribute to the increased susceptibility to infections and chronic bacterial colonization that is a central feature in subjects with chronic bronchitis/COPD. It is unknown at this time if impaired macrophage function is secondary to tobacco-induced effects, or is a central pathologic feature of chronic bronchitis/COPD.

We will explore the expression of innate immune cell surface molecule expression involved in antigen presentation, phagocytic ability, and ex vivo cytokine responses in airway macrophages obtained by induced sputum. We will also collect blood to determine if ex vivo stimulation of blood mimics the inflammatory responses observed with airway macrophages. Comparisons to our past findings in vitro studies, which demonstrated that repetitive organic dust exposure impairs monocyte derived macrophage immune cell surface markers and function, could then be made. This information could lead to future investigations centered on therapeutic interventions to prevent or reverse the underlying lung disease experienced by farmers in this industry.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Three groups Group One : Healthy non-smoking controls Group Two : Smoking adults with chronic bronchitis/COPD Group Three: Non-smoking adults with chronic bronchitis/COPD
Criteria

Inclusion Criteria:

  • Medically stable to participate in induced sputums
  • Group One: Smoked less than 100 cigarettes in their lifetime Quit smoking greater than 10 years ago Pre-bronchodilator FEV1/FVC > 70% Pre-bronchodilator FEV1 % predicted > 80%
  • Group Two: Greater than a 20-pack year tobacco history Smoked in the last two years Post-bronchodilator FEV1/FVC < 70%
  • Group Three:Have less than a 20-pack year tobacco history Quit smoking greater than 20 years ago Post-bronchodilator FEV1/FVC < 70%

Exclusion Criteria:

  • Personal history of lung cancer
  • Pregnancy
  • Personal history of autoimmune disease
  • Currently taking oral/parental corticosteroids
  • Personal history of upper or lower respiratory tract infection in the prior four weeks
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00871637

Locations
United States, Nebraska
University of Nebraska
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska
VA Nebraska Western Iowa Health Care System
Investigators
Principal Investigator: Jill A Poole, MD University of Nebraska
  More Information

Publications:
Responsible Party: Jill Poole, MD, Principal Investigator, University of Nebraska
ClinicalTrials.gov Identifier: NCT00871637     History of Changes
Other Study ID Numbers: 222-08-FB
Study First Received: March 26, 2009
Last Updated: August 30, 2017

Keywords provided by Jill Poole, MD, University of Nebraska:
Pulmonary disease, chronic obstructive
Airway macrophages
Sputum milieu
Airway inflammation
Occupational diseases

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Bronchitis
Tobacco Use Disorder
Bronchitis, Chronic
Occupational Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Tract Infections
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 21, 2017