Mucus Dehydration and Evolution of Chronic Obstructive Pulmonary Disease (COPD) Lung Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00903955|
Recruitment Status : Completed
First Posted : May 19, 2009
Last Update Posted : February 7, 2013
|Condition or disease||Intervention/treatment|
|Chronic Obstructive Pulmonary Disease Chronic Bronchitis||Other: 7% hypertonic saline|
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 :||Observational|
|Actual Enrollment :||100 participants|
|Official Title:||SCCOR in Host Factors in Chronic Lung Disease|
|Study Start Date :||September 2006|
|Primary Completion Date :||March 2012|
|Study Completion Date :||March 2012|
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.
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 ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00903955
|United States, North Carolina|
|University of North Carolina Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Richard Boucher, MD||University of North Carolina, Chapel Hill|