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

NCT ID: NCT00903955

Last Updated: 2013-02-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2012-03-31

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.

Conditions

Chronic Obstructive Pulmonary Disease; Chronic Bronchitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

7% hypertonic saline

Intervention Type: OTHER

Administered via jet nebulizer to subjects in specific aim 3

Interventions

7% hypertonic saline

Administered via jet nebulizer to subjects in specific aim 3

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 82 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Richard C Boucher, MD

Director of Cystic Fibrosis Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard Boucher, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

5P50HL084934-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

05-2876

Identifier Type: -

Identifier Source: org_study_id