Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00903955
Recruitment Status : Completed
First Posted : May 19, 2009
Last Update Posted : February 7, 2013
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

Tracking Information
First Submitted Date May 17, 2009
First Posted Date May 19, 2009
Last Update Posted Date February 7, 2013
Study Start Date September 2006
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 8, 2010)
Mucociliary clearance of inhaled tc99m [ Time Frame: 24 hours ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: February 6, 2013)
Identification of bacterial and viral communities in mucus samples; analysis of biochemical and biophysical properties of mucus [ Time Frame: March 2012 ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Mucus Dehydration and Evolution of Chronic Obstructive Pulmonary Disease (COPD) Lung Disease
Official Title SCCOR in Host Factors in Chronic Lung Disease
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood
Sampling Method Non-Probability Sample
Study Population Community members with a history of cigarette smoking and COPD/chronic bronchitis.
Condition
  • Chronic Obstructive Pulmonary Disease
  • Chronic Bronchitis
Intervention Other: 7% hypertonic saline
Administered via jet nebulizer to subjects in specific aim 3
Study Groups/Cohorts 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.
Intervention: Other: 7% hypertonic saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 6, 2013)
100
Original Estimated Enrollment
 (submitted: May 18, 2009)
90
Actual Study Completion Date March 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 82 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00903955
Other Study ID Numbers 05-2876
5P50HL084934-02 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Richard C Boucher, MD, University of North Carolina, Chapel Hill
Original Responsible Party Richard Boucher, MD, The University of North Carolina, Chapel Hill
Current Study Sponsor University of North Carolina, Chapel Hill
Original Study Sponsor Same as current
Collaborators
  • National Institutes of Health (NIH)
  • National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Richard Boucher, MD University of North Carolina, Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date February 2013