An observational study in Chronic Obstructive Pulmonary Disease and Chronic Bronchitis, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 18 Years to 82 Years. Per ClinicalTrials.gov, last updated 2013-02-07.
Sponsored by University of North Carolina, Chapel Hill · Observational
The purpose of this research is to understand the properties of mucus in persons with COPD, specifically Chronic Bronchitis. We hypothesize that those with Chronic Bronchitis have dehydrated mucus, and thus have a harder time coughing it out of their lungs. This leads to a greater vulnerability for lung infection, inflammation and airflow obstruction. Ultimately, our goal is to understand how mucus dehydration contributes to the progression of COPD/Chronic Bronchitis so that better therapies and interventions can be developed for future generations.
Specific Aim I directly tests the hypothesis that mucus clearance is impaired due to mucus dehydration. It measures 1) COPD Mucociliary and Cough Clearance 2) mucus hydration 3) the concentrations of the dominant regulators of airway hydration and 4) the consequences of mucus dehydration on mucus biophysical properties and bacterial infection.
Specific Aim II tests the hypothesis that COPD acute exacerbations are associated with failures of mucus clearance. Measurements will be similar to that of Specific Aim I, but conducted during periods of baseline health, acute exacerbation and recovery.
Specific Aim III tests whether airway surface hydration with 7% Hypertonic Saline will restore clearance in the basal state and during a COPD acute exacerbation. COPD subjects will be exposed to inhaled Hypertonic Saline during periods of baseline health and acute exacerbation. Acute efficacy via measures of mucus clearance and spirometry will studied.
268 studies on the registry are indexed under Bronchitis; 26 are open to participants now.
This study's enrollment of 100 is below the median of 446 across 70 observational studies indexed under Bronchitis.
Browse Bronchitis studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Community members with a history of cigarette smoking and COPD/chronic bronchitis.
Exclusion Criteria:
Subjects diagnosed with COPD are classified according to standards set forth by the Global Initiative on Obstructive Lung Disease. This study recruits subjects in each of three GOLD categories.
Other: 7% hypertonic saline
Administered via jet nebulizer to subjects in specific aim 3
Mucociliary clearance of inhaled tc99m
Time frame: 24 hours
Identification of bacterial and viral communities in mucus samples; analysis of biochemical and biophysical properties of mucus
Time frame: March 2012
This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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University of North Carolina, Chapel Hill