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History of Changes for Study: NCT00903955
Mucus Dehydration and Evolution of Chronic Obstructive Pulmonary Disease (COPD) Lung Disease
Latest version (submitted February 6, 2013) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 18, 2009 None (earliest Version on record)
2 March 25, 2010 Contacts/Locations, Study Status, Study Identification, Study Design and Sponsor/Collaborators
3 July 8, 2010 Study Status, Study Description, Eligibility and Outcome Measures
4 April 25, 2011 Study Status, Outcome Measures, Groups and Interventions and Conditions
5 February 6, 2013 Recruitment Status, Study Status, Sponsor/Collaborators, Contacts/Locations, Groups and Interventions, Study Design, Study Description, Outcome Measures and Study Identification
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Study NCT00903955
Submitted Date:  May 18, 2009 (v1)

Open or close this module Study Identification
Unique Protocol ID: 5P50HL084934-02
Brief Title: Mucus Dehydration and Evolution of Chronic Obstructive Pulmonary Disease (COPD) Lung Disease
Official Title: Mucus Dehydration and Evolution of COPD Lung Disease
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2009
Overall Status: Recruiting
Study Start: September 2006
Primary Completion:
Study Completion:
First Submitted: May 17, 2009
First Submitted that
Met QC Criteria:
May 18, 2009
First Posted: May 19, 2009 [Estimate]
Last Update Submitted that
Met QC Criteria:
May 18, 2009
Last Update Posted: May 19, 2009 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: University of North Carolina, Chapel Hill
Responsible Party:
Collaborators: National Institutes of Health (NIH)
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The purpose of this research is to understand the properties of mucus in persons with COPD, specifically Chronic Bronchitis. The investigators 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, the investigators' goal is to understand how mucus dehydration contributes to the progression of Chronic Bronchitis so that the investigators can develop better therapies and cures 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 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 be tested.

Open or close this module Conditions
Conditions: Chronic Obstructive Pulmonary Disease
Chronic Bronchitis
Keywords: Mucus
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Cross-Sectional
Biospecimen Retention:
Biospecimen Description:
Enrollment: 90 [Anticipated]
Number of Groups/Cohorts 0
Open or close this module Groups and Interventions
Open or close this module Outcome Measures
Open or close this module Eligibility
Study Population: Community members with a history of cigarette smoking and COPD/chronic bronchitis.
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age: 82 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • history of COPD/chronic bronchitis as 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:

  • clinically diagnosed asthma
  • unstable lung disease
  • allergy to study medications
  • radiation exposure within past year exceeding Federal Regulation Limits
Open or close this module Contacts/Locations
Central Contact Person: Olivia Perlmutt
Telephone: (919) 966-2531
Email: operlmut@med.unc.edu
Central Contact Backup: Fred Fuller, RN
Telephone: (919) 966-2531
Email: fred_fuller@med.unc.edu
Study Officials: Richard Boucher, MD
Principal Investigator
University of North Carolina, Chapel Hill
Locations: United States, North Carolina
University of North Carolina Chapel Hill
[Recruiting]
Chapel Hill, North Carolina, United States, 27599
Contact:Contact: Olivia Perlmutt 919-966-2531 operlmut@med.unc.edu
Contact:Contact: Fred Fuller, RN (919) 966-2531 fred_fuller@med.unc.edu
Contact:Sub-Investigator: Ashley Henderson, MD
Contact:Sub-Investigator: Raymond Coakley, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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