Chronic Obstructive Pulmonary DiseaseNCT00903955
Mucus Dehydration and Evolution of Chronic Obstructive Pulmonary Disease (COPD) Lung Disease
An observational study of Chronic Obstructive Pulmonary Disease and Chronic Bronchitis, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 82 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Chronic Bronchitis
- What is being tested?
- 7% hypertonic saline
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Mar 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community members with a history of cigarette smoking and COPD/chronic bronchitis.
Who may be able to join
- 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
Who cannot join
- unstable lung disease
- allergy to study medications
- radiation exposure within past year exceeding Federal Regulation Limits
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: SCCOR in Host Factors in Chronic Lung Disease
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.
Read the 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.
- Being tested
- 7% hypertonic saline
- Keywords
- Mucus, COPD, Chronic Bronchitis
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7% hypertonic salineOther
Administered via jet nebulizer to subjects in specific aim 3
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: 7% hypertonic saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mucociliary clearance of inhaled tc99m
Measured: 24 hours
Secondary outcomes (1)
Identification of bacterial and viral communities in mucus samples; analysis of biochemical and biophysical properties of mucus
Measured: March 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2009 (estimated)
- Study startSep 2006
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Richard C Boucher, MD, University of North Carolina, Chapel Hill
- Investigators
- Richard Boucher, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00903955
- Sponsor's protocol ID
- 05-2876
- Other IDs
- 5P50HL084934-02
- Status last verified
- Feb 2013
- First submitted
- 17 May 2009
- Last updated
- 7 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCCOR in Host Factors in Chronic Lung Disease
- ClinicalTrials.gov ID
- NCT00903955
- Acronym / sponsor ID
- 05-2876
- Keywords
- Mucus, COPD, Chronic Bronchitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2006
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 19 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Obstructive Pulmonary Disease | – | Other: 7% hypertonic salineSubjects 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. |
Who may qualify
- Ages
- 18 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community members with a history of cigarette smoking and COPD/chronic bronchitis.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- unstable lung disease
- allergy to study medications
- radiation exposure within past year exceeding Federal Regulation Limits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 7% hypertonic salineAdministered via jet nebulizer to subjects in specific aim 3 | Other | Chronic Obstructive Pulmonary Disease |
Primary outcome
Mucociliary clearance of inhaled tc99m
Time frame: 24 hours
1 secondary outcome
Identification of bacterial and viral communities in mucus samples; analysis of biochemical and biophysical properties of mucus
Time frame: March 2012
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Boucher, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease and Chronic Bronchitis, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mucociliary clearance of inhaled tc99m (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2013.