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

NCT00903955 | Completed DMC

• 2 other identifiers: 05-28765P50HL084934-02
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease; Chronic Bronchitis

Keywords

Mucus; COPD; Chronic Bronchitis

Outcome Measures

Primary Outcomes (1)

• Mucociliary clearance of inhaled tc99m

  24 hours

Secondary Outcomes (1)

• Identification of bacterial and viral communities in mucus samples; analysis of biochemical and biophysical properties of mucus

  March 2012

Study Arms (1)

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

Interventions

7% hypertonic saline OTHER

Administered via jet nebulizer to subjects in specific aim 3

Chronic Obstructive Pulmonary Disease

Eligibility Criteria

• Age: 18 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchitis, Chronic

Interventions

Saline Solution, Hypertonic

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases

Intervention Hierarchy (Ancestors)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Richard Boucher, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cystic Fibrosis Center

Study Record Dates

• First Submitted: May 17, 2009
• First Posted: May 19, 2009
• Study Start: September 1, 2006
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: February 7, 2013

Record last verified: 2013-02

Locations

US (1)