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Mucus Dehydration and Evolution of Chronic Obstructive Pulmonary Disease (COPD) Lung Disease

SCCOR in Host Factors in Chronic Lung Disease

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00903955
Enrollment
100
Registered
2009-05-19
Start date
2006-09-30
Completion date
2012-03-31
Last updated
2013-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease, Chronic Bronchitis

Keywords

Mucus, COPD, Chronic Bronchitis

Brief summary

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.

Detailed description

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.

Interventions

Administered via jet nebulizer to subjects in specific aim 3

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 82 Years
Healthy volunteers
No

Inclusion criteria

* history of COPD/chronic bronchitis defined as having a productive cough for three months of the year for at least two successive years * greater than or equal to a 10 pack year cigarette smoking history * ability to perform spirometry

Exclusion criteria

* unstable lung disease * allergy to study medications * radiation exposure within past year exceeding Federal Regulation Limits

Design outcomes

Primary

MeasureTime frame
Mucociliary clearance of inhaled tc99m24 hours

Secondary

MeasureTime frame
Identification of bacterial and viral communities in mucus samples; analysis of biochemical and biophysical properties of mucusMarch 2012

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026