Lung DiseaseNCT00843414
Immunological Characterization of Bronchoalveolar Cells in Normals
An observational study of Lung Disease, run by Ohio State University at 1 site in United States.
Trial summary
To obtain the monocytes (white blood cells) from normal volunteers for the purpose of studying how proteins, fats, carbohydrates, as well as RNA and DNA for gene expression, relate to immunity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Disease
- How many people
- 1,232 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 1978to Apr 2011
- 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: community sample
Who may be able to join
- healthy
Who cannot join
- unable to consent
Trial locations and contacts
1 site in 1 country.
About this study
To obtain the monocytes (white blood cells) from normal volunteers for the purpose of studying how proteins, fats, carbohydrates, as well as RNA and DNA for gene expression, relate to immunity. This information will be compared to other studies in patients with lung diseases such as Emphysema, Sarcoidosis, and Interstitial Pulmonary Fibrosis.
Read the detailed description
To determine the functional capabilities of cells obtained from bronchoalveolar lavage fluid and peripheral blood monocytes from normal individuals. The ongoing objective varies from investigation to investigation but in general the investigational goals are to better understand the immune function of monocytes purified from normal volunteers. In some instances the emphasis will be upon comparing the specific immune function (e.g. ability to sense endotoxin and release a cytokine) from blood monocytes as compared to human alveolar macrophages. This comparison is not the only goal of the study, however. In many cases the immune function of the monocyte will be sufficient in and of itself as an investigational goal. In other cases the same is true of alveolar macrophage function.
- Conditions
- Lung Disease
- Keywords
- Emphysema, Sarcoidosis, Interstitial Pulmonary Fibrosis
- Medical subject headings
- Lung Diseases, Emphysema, Sarcoidosis, Pulmonary Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
comparing the specific immune function (e.g. ability to sense endotoxin and release a cytokine) from blood monocytes as compared to human alveolar macrophages
Measured: end of study
Secondary outcomes (1)
Analysis of lung proteins present in BAL fluid
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 posted13 Feb 2009 (estimated)
- Study startMar 1978
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseaseStudies 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
- 1,232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark D. Wewers, MD, Ohio State University
- Investigators
- Mark D Wewers, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00843414
- Sponsor's protocol ID
- 1978H0059
- Status last verified
- Apr 2011
- First submitted
- 12 Feb 2009
- Last updated
- 7 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunological Characterization of Bronchoalveolar Cells in Normals
- ClinicalTrials.gov ID
- NCT00843414
- Acronym / sponsor ID
- 1978H0059
- Conditions
- Lung Disease
- Keywords
- Emphysema, Sarcoidosis, Interstitial Pulmonary Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,232 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Mar 1978
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 13 Feb 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.
To obtain the monocytes (white blood cells) from normal volunteers for the purpose of studying how proteins, fats, carbohydrates, as well as RNA and DNA for gene expression, relate to immunity. This information will be compared to other studies in patients with lung diseases such as Emphysema, Sarcoidosis, and Interstitial Pulmonary Fibrosis.
Detailed description
To determine the functional capabilities of cells obtained from bronchoalveolar lavage fluid and peripheral blood monocytes from normal individuals. The ongoing objective varies from investigation to investigation but in general the investigational goals are to better understand the immune function of monocytes purified from normal volunteers. In some instances the emphasis will be upon comparing the specific immune function (e.g. ability to sense endotoxin and release a cytokine) from blood monocytes as compared to human alveolar macrophages. This comparison is not the only goal of the study, however. In many cases the immune function of the monocyte will be sufficient in and of itself as an investigational goal. In other cases the same is true of alveolar macrophage function.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- community sample
Key inclusion criteria (1 listed)
- healthy
Key exclusion criteria (1 listed)
- unable to consent
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
comparing the specific immune function (e.g. ability to sense endotoxin and release a cytokine) from blood monocytes as compared to human alveolar macrophages
Time frame: end of study
1 secondary outcome
Analysis of lung proteins present in BAL fluid
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 7 Jul 2016.
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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.
Mark D Wewers, 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 Lung Disease, 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 1 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 7 Jul 2016. 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?
comparing the specific immune function (e.g. ability to sense endotoxin and release a cytokine) from blood monocytes as compared to human alveolar macrophages (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 7 Jul 2016; AzTrials last refreshed its copy on 7 Nov 2026.