An observational study in Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic and Occupational Diseases, sponsored by University of Nebraska. Completed at 1 site in United States. Open to participants aged 50 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-07.
Sponsored by University of Nebraska · Observational
Airway macrophage impairment is a central feature in the immunopathogenesis of chronic obstructive pulmonary disease, regardless of smoking status.
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.
4,252 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.
This study's enrollment of 30 is below the median of 183 across 1,099 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →University of Nebraska is the lead sponsor of 495 studies on the registry; 68 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 52 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
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Exclusion Criteria:
Healthy non-smoking controls
Smoking adults with chronic bronchitis/chronic obstructive pulmonary disease
Non-smoking adults with chronic bronchitis/chronic obstructive pulmonary disease
Comparison of airway macrophages for immune cell surface marker expression and phagocytic ability in adults with airflow obstruction & healthy controls
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.
Time frame: One year
Comparison of airway macrophages for cytokine responsiveness in adults with airflow obstruction & healthy controls
Determine if airway macrophages from adult participants with airflow obstruction demonstrate impaired cytokine responsiveness compared to healthy controls.
Time frame: One year
Comparison of airway macrophage cytokine responsiveness to whole blood cytokine responsiveness
Determine if airway macrophage cytokine responsiveness is comparable to whole blood cytokine responsiveness.
Time frame: One year
Determining if immunomodulators in airway sputum milieu f predict airway macrophage phenotype and function
To determine if airway sputum milieu for potential immunomodulators predict airway macrophage phenotype and function.
Time frame: One year
Ran from Aug 2008 to primary completion in Jun 2009, 10 months.
Of 330 non-industry observational studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 86. This study's 10 months is below that.
Counting every sponsor, half of 429 studies reached it within 28 months; a quarter within 16 and three quarters within 62.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive →