- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00903955
Mucus Dehydration and Evolution of Chronic Obstructive Pulmonary Disease (COPD) Lung Disease
SCCOR in Host Factors in Chronic Lung Disease
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina Chapel Hill
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Chronic Obstructive Pulmonary Disease
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.
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Administered via jet nebulizer to subjects in specific aim 3
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mucociliary clearance of inhaled tc99m
Time Frame: 24 hours
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24 hours
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Identification of bacterial and viral communities in mucus samples; analysis of biochemical and biophysical properties of mucus
Time Frame: March 2012
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March 2012
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Collaborators and Investigators
Investigators
- Principal Investigator: Richard Boucher, MD, University of North Carolina, Chapel Hill
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05-2876
- 5P50HL084934-02 (U.S. NIH Grant/Contract)
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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