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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

SCCOR in Host Factors in Chronic Lung Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00903955
• Other study ID #: 05-2876
• Secondary ID: 5P50HL084934-02
• Status: Completed
• Phase: N/A
• First received: May 17, 2009
• Last updated: February 6, 2013
• Start date: September 2006
• Est. completion date: March 2012

Study information

• Verified date: February 2013
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 82 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Bronchitis
• Bronchitis, Chronic
• Chronic Bronchitis
• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
United States	University of North Carolina Chapel Hill	Chapel Hill	North Carolina

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mucociliary clearance of inhaled tc99m		24 hours	No
Secondary	Identification of bacterial and viral communities in mucus samples; analysis of biochemical and biophysical properties of mucus		March 2012	No