COPDNCT00806091
Functional Proteomics of Alveolar Macrophages
An observational study of COPD, run by Ohio State University at 1 site in United States.
Trial summary
The purpose of this study is to obtain young white blood cells (monocytes) from the investigators donated blood for research into how these cells change into large, mature white blood cells (macrophages) and how smoking causes Chronic Obstructive Pulmonary Disease (COPD). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COPD
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Dec 2008
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: smokers with and without COPD, general population
Who may be able to join
- COPD, smoker
- COPD, non smoker
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to obtain young white blood cells (monocytes) from the investigators donated blood for research into how these cells change into large, mature white blood cells (macrophages) and how smoking causes Chronic Obstructive Pulmonary Disease (COPD).
Read the detailed description
Our research goal is to identify new targets and strategies to help care for patients with Chronic Obstructive Pulmonary Disease (COPD). COPD is a chronic airway inflammatory disorder characterized by a progressive loss of pulmonary function. Mononuclear phagocytes are known to be critically involved in both repair/remodeling and destructive events in COPD. Although smoking is the chief environmental risk factor for COPD, the molecular details responsible for the genesis and progression of smoking-mediated COPD require further investigation. In searching for new knowledge and research strategies for this challenging topic, we have made substantial progress in mononuclear phagocyte proteomics and laid the groundwork for this translational research of COPD.
- Conditions
- COPD
- Keywords
- AM proteomes will be compared between smokers with and without COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
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 |
|---|---|---|
| COPD subjects | healthy subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
to define AM's pathogenic pathways underlying the development of COPD
Measured: end of study
Secondary outcomes (1)
to determine protein polymorphism(s) that impact genetic susceptibility to COPD
Measured: end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2008 (estimated)
- Study startJul 2004
- Primary completionSep 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Diaz, Ohio State University
- Investigators
- Haifeng Wu, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00806091
- Sponsor's protocol ID
- 2004H0102
- Status last verified
- Oct 2021
- First submitted
- 9 Dec 2008
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Proteomics of Alveolar Macrophages
- ClinicalTrials.gov ID
- NCT00806091
- Acronym / sponsor ID
- 2004H0102
- Conditions
- COPD
- Keywords
- AM proteomes will be compared between smokers with and without COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Jul 2004
- Primary completion
- Sep 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 10 Dec 2008 (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 study is to obtain young white blood cells (monocytes) from the investigators donated blood for research into how these cells change into large, mature white blood cells (macrophages) and how smoking causes Chronic Obstructive Pulmonary Disease (COPD).
Detailed description
Our research goal is to identify new targets and strategies to help care for patients with Chronic Obstructive Pulmonary Disease (COPD). COPD is a chronic airway inflammatory disorder characterized by a progressive loss of pulmonary function. Mononuclear phagocytes are known to be critically involved in both repair/remodeling and destructive events in COPD. Although smoking is the chief environmental risk factor for COPD, the molecular details responsible for the genesis and progression of smoking-mediated COPD require further investigation. In searching for new knowledge and research strategies for this challenging topic, we have made substantial progress in mononuclear phagocyte proteomics and laid the groundwork for this translational research of COPD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD subjects | – | –healthy subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- smokers with and without COPD, general population
Key inclusion criteria (2 listed)
- COPD, smoker
- COPD, non smoker
Key exclusion criteria (1 listed)
- none
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
to define AM's pathogenic pathways underlying the development of COPD
Time frame: end of study
1 secondary outcome
to determine protein polymorphism(s) that impact genetic susceptibility to COPD
Time frame: end of study
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 1 Nov 2021.
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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.
Haifeng Wu, MD principal investigator
Ohio State University
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 COPD, run by Ohio State University 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 2 inclusion and 1 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 1 Nov 2021. 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?
to define AM's pathogenic pathways underlying the development of COPD (time frame: end of study). 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 1 Nov 2021.