Airway Macrophages and Sputum Milieu in Adult Subjects With Airflow Obstruction

NCT ID: NCT00871637

Last Updated: 2023-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-01

Study Completion Date

2009-06-01

Brief Summary

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Airway macrophage impairment is a central feature in the immunopathogenesis of chronic obstructive pulmonary disease, regardless of smoking status.

Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group One

Healthy non-smoking controls

No interventions assigned to this group

Group Two

Smoking adults with chronic bronchitis/chronic obstructive pulmonary disease

No interventions assigned to this group

Group Three

Non-smoking adults with chronic bronchitis/chronic obstructive pulmonary disease

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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VA Nebraska Western Iowa Health Care System

FED

Sponsor Role collaborator

University of Nebraska

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jill A Poole, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

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University of Nebraska

Omaha, Nebraska, United States

Site Status

Countries

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United States

References

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Harting JR, Gleason A, Romberger DJ, Von Essen SG, Qiu F, Alexis N, Poole JA. Chronic obstructive pulmonary disease patients have greater systemic responsiveness to ex vivo stimulation with swine dust extract and its components versus healthy volunteers. J Toxicol Environ Health A. 2012;75(24):1456-70. doi: 10.1080/15287394.2012.722186.

Reference Type RESULT
PMID: 23116451 (View on PubMed)

Other Identifiers

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0222-08-FB

Identifier Type: -

Identifier Source: org_study_id

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