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

This study has been completed.
Sponsor:
Collaborators:
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
ClinicalTrials.gov Identifier:
NCT00903955
First received: May 17, 2009
Last updated: February 6, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention
Chronic Obstructive Pulmonary Disease
Chronic Bronchitis
 Other: 7% hypertonic saline

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: SCCOR in Host Factors in Chronic Lung Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Mucociliary clearance of inhaled tc99m [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Identification of bacterial and viral communities in mucus samples; analysis of biochemical and biophysical properties of mucus [ Time Frame: March 2012 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood


Enrollment: 100
Study Start Date: September 2006
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 82 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Community members with a history of cigarette smoking and COPD/chronic bronchitis.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00903955

Locations
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)
Investigators
Principal Investigator: Richard Boucher, MD University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: Richard C Boucher, MD, Director of Cystic Fibrosis Center, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00903955     History of Changes
Other Study ID Numbers: 05-2876, 5P50HL084934-02
Study First Received: May 17, 2009
Last Updated: February 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Mucus
COPD
Chronic Bronchitis

Additional relevant MeSH terms:
Bronchitis
Bronchitis, Chronic
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
 Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on May 23, 2013