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

Completed

• Conditions: Chronic Obstructive Pulmonary Disease; Chronic Bronchitis
• Interventions: Other: 7% hypertonic saline

• Registration Number: NCT00903955
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2006-09
• Study First Submitted: 2009-05-17
• Study First Submitted QC: 2009-05-18
• Study First Posted: 2009-05-19
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-06
• Last Update Posted: 2013-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

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Exclusion Criteria

• unstable lung disease
• allergy to study medications
• radiation exposure within past year exceeding Federal Regulation Limits

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronic Obstructive Pulmonary Disease	7% hypertonic saline	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.

Primary Outcome Measures

Name	Time	Method
Mucociliary clearance of inhaled tc99m	24 hours

Secondary Outcome Measures

Name	Time	Method
Identification of bacterial and viral communities in mucus samples; analysis of biochemical and biophysical properties of mucus	March 2012

Trial Locations

Locations (1)

University of North Carolina Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States