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

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ClinicalTrials.gov Identifier: NCT00903955
Recruitment Status : Completed
First Posted : May 19, 2009
Last Update Posted : February 7, 2013
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Richard C Boucher, MD, University of North Carolina, Chapel Hill

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.

Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease Chronic Bronchitis Other: 7% hypertonic saline

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.

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: SCCOR in Host Factors in Chronic Lung Disease
Study Start Date : September 2006
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

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.
Other: 7% hypertonic saline
Administered via jet nebulizer to subjects in specific aim 3

Primary Outcome Measures :
  1. Mucociliary clearance of inhaled tc99m [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 82 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community members with a history of cigarette smoking and COPD/chronic bronchitis.

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

Information from the National Library of Medicine

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

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United States, North Carolina
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Richard Boucher, MD University of North Carolina, Chapel Hill
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Responsible Party: Richard C Boucher, MD, Director of Cystic Fibrosis Center, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00903955    
Other Study ID Numbers: 05-2876
5P50HL084934-02 ( U.S. NIH Grant/Contract )
First Posted: May 19, 2009    Key Record Dates
Last Update Posted: February 7, 2013
Last Verified: February 2013
Keywords provided by Richard C Boucher, MD, University of North Carolina, Chapel Hill:
Chronic Bronchitis
Additional relevant MeSH terms:
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Bronchitis, Chronic
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections
Bronchial Diseases