- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00871637
Airway Macrophages and Sputum Milieu in Adult Subjects With Airflow Obstruction
Study Overview
Status
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Nebraska
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Omaha, Nebraska, United States, 68198
- University of Nebraska
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Group One
Healthy non-smoking controls
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Group Two
Smoking adults with chronic bronchitis/chronic obstructive pulmonary disease
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Group Three
Non-smoking adults with chronic bronchitis/chronic obstructive pulmonary disease
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of airway macrophages for immune cell surface marker expression and phagocytic ability in adults with airflow obstruction & healthy controls
Time Frame: One year
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Determine if airway macrophages from adult participants with airflow obstruction demonstrate impaired innate immune cell surface marker expression and phagocytic ability compared to healthy controls.
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One year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of airway macrophages for cytokine responsiveness in adults with airflow obstruction & healthy controls
Time Frame: One year
|
Determine if airway macrophages from adult participants with airflow obstruction demonstrate impaired cytokine responsiveness compared to healthy controls.
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One year
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Comparison of airway macrophage cytokine responsiveness to whole blood cytokine responsiveness
Time Frame: One year
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Determine if airway macrophage cytokine responsiveness is comparable to whole blood cytokine responsiveness.
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One year
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Determining if immunomodulators in airway sputum milieu f predict airway macrophage phenotype and function
Time Frame: One year
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To determine if airway sputum milieu for potential immunomodulators predict airway macrophage phenotype and function.
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One year
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jill A Poole, MD, University of Nebraska
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Pathologic Processes
- Substance-Related Disorders
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Disease Attributes
- Bronchial Diseases
- Lung Diseases, Obstructive
- Lung Diseases
- Pulmonary Disease, Chronic Obstructive
- Tobacco Use Disorder
- Chronic Disease
- Bronchitis
- Bronchitis, Chronic
- Occupational Diseases
Other Study ID Numbers
- 0222-08-FB
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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