Pulmonary Disease, Chronic ObstructiveNCT00871637
Airway Macrophages and Sputum Milieu in Adult Subjects With Airflow Obstruction
An observational study of Pulmonary Disease, Chronic Obstructive and Bronchitis, Chronic, run by University of Nebraska at 1 site in United States.
Trial summary
Airway macrophage impairment is a central feature in the immunopathogenesis of chronic obstructive pulmonary disease, regardless of smoking status. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic, Occupational Diseases
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2008to 1 Jun 2009
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Three groups Group One : Healthy non-smoking controls Group Two : Smoking adults with chronic bronchitis/COPD Group Three: Non-smoking adults with chronic bronchitis/COPD
Who may be able to join
- Medically stable to participate in induced sputums
- Group One: Smoked less than 100 cigarettes in their lifetime Quit smoking greater than 10 years ago Pre-bronchodilator FEV1/FVC > 70% Pre-bronchodilator FEV1 % predicted > 80%
- Group Two: Greater than a 20-pack year tobacco history Smoked in the last two years Post-bronchodilator FEV1/FVC < 70%
- Group Three:Have less than a 20-pack year tobacco history Quit smoking greater than 20 years ago Post-bronchodilator FEV1/FVC < 70%
Who cannot join
- Personal history of lung cancer
- Pregnancy
- Personal history of autoimmune disease
- Currently taking oral/parental corticosteroids
- Personal history of upper or lower respiratory tract infection in the prior four weeks
Trial locations and contacts
1 site in 1 country.
About this study
Airway macrophage impairment is a central feature in the immunopathogenesis of chronic obstructive pulmonary disease, regardless of smoking status.
Read the detailed description
In the United States, a variety of farming operations can generate significant amounts of dust. Chronic organic dust exposure to workers in this industry can result in several respiratory health conditions including chronic bronchitis, chronic obstructive pulmonary disease (COPD), and exacerbations of asthma. Organic dust is a complex mixture containing particulate matter and microbial-associated components from gram positive and gram negative bacteria. Airway macrophages are key innate immune cells that are rapidly activated by exposure to inhaled toxins and organic dust.
The literature indicates that subjects with tobacco-induced chronic bronchitis/COPD have alveolar macrophages that have impaired function. It has been hypothesized that the impaired lung macrophage function may contribute to the increased susceptibility to infections and chronic bacterial colonization that is a central feature in subjects with chronic bronchitis/COPD. It is unknown at this time if impaired macrophage function is secondary to tobacco-induced effects, or is a central pathologic feature of chronic bronchitis/COPD.
We will explore the expression of innate immune cell surface molecule expression involved in antigen presentation, phagocytic ability, and ex vivo cytokine responses in airway macrophages obtained by induced sputum. We will also collect blood to determine if ex vivo stimulation of blood mimics the inflammatory responses observed with airway macrophages. Comparisons to our past findings in vitro studies, which demonstrated that repetitive organic dust exposure impairs monocyte derived macrophage immune cell surface markers and function, could then be made. This information could lead to future investigations centered on therapeutic interventions to prevent or reverse the underlying lung disease experienced by farmers in this industry.
- Conditions
- Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic, Occupational Diseases, Tobacco Use Disorder
- Keywords
- Pulmonary disease, chronic obstructive, Airway macrophages, Sputum milieu, Airway inflammation, Occupational diseases
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic, Occupational Diseases, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group One | Healthy non-smoking controls | |
| Group Two | Smoking adults with chronic bronchitis/chronic obstructive pulmonary disease | |
| Group Three | Non-smoking adults with chronic bronchitis/chronic obstructive pulmonary disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of airway macrophages for immune cell surface marker expression and phagocytic ability in adults with airflow obstruction & healthy controls
Determine if airway macrophages from adult participants with airflow obstruction demonstrate impaired innate immune cell surface marker expression and phagocytic ability compared to healthy controls.
Measured: One year
Secondary outcomes (3)
Comparison of airway macrophages for cytokine responsiveness in adults with airflow obstruction & healthy controls
Determine if airway macrophages from adult participants with airflow obstruction demonstrate impaired cytokine responsiveness compared to healthy controls.
Measured: One year
Comparison of airway macrophage cytokine responsiveness to whole blood cytokine responsiveness
Determine if airway macrophage cytokine responsiveness is comparable to whole blood cytokine responsiveness.
Measured: One year
Determining if immunomodulators in airway sputum milieu f predict airway macrophage phenotype and function
To determine if airway sputum milieu for potential immunomodulators predict airway macrophage phenotype and function.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2009 (estimated)
- Study start1 Aug 2008
- Primary completion1 Jun 2009
- Study completion1 Jun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- VA Nebraska Western Iowa Health Care System
- Responsible party
- Sponsor
- Investigators
- Jill A Poole, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00871637
- Sponsor's protocol ID
- 0222-08-FB
- Status last verified
- Sep 2023
- First submitted
- 26 Mar 2009
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Harting JR, Gleason A, Romberger DJ, Von Essen SG, Qiu F, Alexis N, Poole JA. Chronic obstructive pulmonary disease patients have greater systemic responsiveness to ex vivo stimulation with swine dust extract and its components versus healthy volunteers. J Toxicol Environ Health A. 2012;75(24):1456-70. doi: 10.1080/15287394.2012.722186.
PubMed 23116451
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway Macrophages and Sputum Milieu in Adult Subjects With Airflow Obstruction
- ClinicalTrials.gov ID
- NCT00871637
- Acronym / sponsor ID
- 0222-08-FB
- Conditions
- Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic, Occupational Diseases, Tobacco Use Disorder
- Keywords
- Pulmonary disease, chronic obstructive, Airway macrophages, Sputum milieu, Airway inflammation, Occupational diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- VA Nebraska Western Iowa Health Care System
- Study start
- 1 Aug 2008 (actual)
- Primary completion
- 1 Jun 2009 (actual)
- Study completion
- 1 Jun 2009 (actual)
- First posted
- 30 Mar 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.
Airway macrophage impairment is a central feature in the immunopathogenesis of chronic obstructive pulmonary disease, regardless of smoking status.
Detailed description
In the United States, a variety of farming operations can generate significant amounts of dust. Chronic organic dust exposure to workers in this industry can result in several respiratory health conditions including chronic bronchitis, chronic obstructive pulmonary disease (COPD), and exacerbations of asthma. Organic dust is a complex mixture containing particulate matter and microbial-associated components from gram positive and gram negative bacteria. Airway macrophages are key innate immune cells that are rapidly activated by exposure to inhaled toxins and organic dust.
The literature indicates that subjects with tobacco-induced chronic bronchitis/COPD have alveolar macrophages that have impaired function. It has been hypothesized that the impaired lung macrophage function may contribute to the increased susceptibility to infections and chronic bacterial colonization that is a central feature in subjects with chronic bronchitis/COPD. It is unknown at this time if impaired macrophage function is secondary to tobacco-induced effects, or is a central pathologic feature of chronic bronchitis/COPD.
We will explore the expression of innate immune cell surface molecule expression involved in antigen presentation, phagocytic ability, and ex vivo cytokine responses in airway macrophages obtained by induced sputum. We will also collect blood to determine if ex vivo stimulation of blood mimics the inflammatory responses observed with airway macrophages. Comparisons to our past findings in vitro studies, which demonstrated that repetitive organic dust exposure impairs monocyte derived macrophage immune cell surface markers and function, could then be made. This information could lead to future investigations centered on therapeutic interventions to prevent or reverse the underlying lung disease experienced by farmers in this industry.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group One | – | –Healthy non-smoking controls |
| Group Two | – | –Smoking adults with chronic bronchitis/chronic obstructive pulmonary disease |
| Group Three | – | –Non-smoking adults with chronic bronchitis/chronic obstructive pulmonary disease |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Three groups Group One : Healthy non-smoking controls Group Two : Smoking adults with chronic bronchitis/COPD Group Three: Non-smoking adults with chronic bronchitis/COPD
Key inclusion criteria (4 listed)
- Medically stable to participate in induced sputums
- Group One: Smoked less than 100 cigarettes in their lifetime Quit smoking greater than 10 years ago Pre-bronchodilator FEV1/FVC > 70% Pre-bronchodilator FEV1 % predicted > 80%
- Group Two: Greater than a 20-pack year tobacco history Smoked in the last two years Post-bronchodilator FEV1/FVC < 70%
- Group Three:Have less than a 20-pack year tobacco history Quit smoking greater than 20 years ago Post-bronchodilator FEV1/FVC < 70%
Key exclusion criteria (5 listed)
- Personal history of lung cancer
- Pregnancy
- Personal history of autoimmune disease
- Currently taking oral/parental corticosteroids
- Personal history of upper or lower respiratory tract infection in the prior four weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of airway macrophages for immune cell surface marker expression and phagocytic ability in adults with airflow obstruction & healthy controls
Time frame: One year
Determine if airway macrophages from adult participants with airflow obstruction demonstrate impaired innate immune cell surface marker expression and phagocytic ability compared to healthy controls.
3 secondary outcomes
Comparison of airway macrophages for cytokine responsiveness in adults with airflow obstruction & healthy controls
Time frame: One year
Comparison of airway macrophage cytokine responsiveness to whole blood cytokine responsiveness
Time frame: One year
Determining if immunomodulators in airway sputum milieu f predict airway macrophage phenotype and function
Time frame: One year
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 Sep 2023.
- Results publication: PubMed 23116451Harting JR, Gleason A, Romberger DJ, Von Essen SG, Qiu F, Alexis N, Poole JA. Chronic obstructive pulmonary disease patients have greater systemic responsiveness to ex vivo stimulation with swine dust extract and its components versus healthy volunteers. J Toxicol Environ Health A. 2012;75(24):1456-70. doi: 10.1080/15287394.2012.722186.
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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.
Jill A Poole, MD principal investigator
University of Nebraska
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 Pulmonary Disease, Chronic Obstructive and Bronchitis, Chronic, run by University of Nebraska 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 4 inclusion and 5 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 Sep 2023. 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?
Comparison of airway macrophages for immune cell surface marker expression and phagocytic ability in adults with airflow obstruction & healthy controls (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00871637, which also lists 1 linked publication.
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 Sep 2023; AzTrials last refreshed its copy on 8 Nov 2026.