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Airway Macrophages and Sputum Milieu in Adult Subjects With Airflow Obstruction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by University of Nebraska.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
VA Nebraska Western Iowa Health Care System
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00871637
First received: March 26, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Determine if airway macrophage cytokine responsiveness is comparable to whole blood cytokine responsiveness. [ Time Frame: One year ] [ Designated as safety issue: No ]
  • To determine if airway sputum milieu for potential immunomodulators predict airway macrophage phenotype and function. [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: August 2008
Estimated Study Completion Date: June 2009
Estimated 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
Genders Eligible for Study:   Both
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

Contacts
Contact: Jill A Poole, MD 402-955-3817 japoole@unmc.edu
Contact: Janel R Harting, MD 402-955-3817 jharting@unmc.edu

Locations
United States, Nebraska
University of Nebraska Recruiting
Omaha, Nebraska, United States, 68198
Contact: Jill A Poole, MD    402-955-3817    japoole@unmc.edu   
Contact: Janel R Harting, MD    402-955-3817    jharting@unmc.edu   
Principal Investigator: Jill A Poole, MD         
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

No publications provided by University of Nebraska

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jill A Poole, M.D., University of Nebraska Medical Center
ClinicalTrials.gov Identifier: NCT00871637     History of Changes
Other Study ID Numbers: 222-08-FB
Study First Received: March 26, 2009
Last Updated: March 26, 2009
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 19, 2014