Chronic Obstructive Pulmonary DiseaseNCT01099410
Apoptotic Cell (AC) Uptake by Human Alveolar Macrophages (AM)
An observational study of Chronic Obstructive Pulmonary Disease, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The purpose of this study is to compare the ability of two types of white blood cells to eat dead host cells, and how this process affects their ability to protect the body from infection. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Fiberoptic bronchoscopy, blood draw and intravenous catheter
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Dec 2015
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Volunteer subjects recruited from the community; may be current or ex-smokers or never-smokers, but must be healthy enough to undergo research bronchoscopy safely.
Who may be able to join
- Veteran or non-Veteran
- Able to give informed consent
Who cannot join
- Unstable heart disease
- Other systemic disease and unlikely to survive at least 2 years
- Mental incompetence
- Prednisone >20 mg/day
- Participation in another interventional protocol within last 6 weeks
- Asthma
Show all 12Show fewer
- Cystic fibrosis
- Clinically significant bronchiectasis
- Lung cancer or any cancer not in remission for at least 5 years
- Other inflammatory or fibrotic lung disease
- Use of antibiotics for a lung infection within the past 4 weeks
- Autoimmune disease, i.e., Rheumatoid arthritis, systemic lupus erythematosus, autoimmune hepatitis, Crohn's disease or other
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105
About this study
Official title: Apoptotic Cell Ingestion by Normal Human Alveolar Macrophages
The purpose of this study is to compare the ability of two types of white blood cells to eat dead host cells, and how this process affects their ability to protect the body from infection. The two cell types are monocytes, a cell in the bloodstream, and alveolar macrophages, a cell in the lung that is ultimately derived from monocytes
Read the detailed description
Volunteers, who may be Veterans or non-Veterans, will be screened by a series of questionnaires, chest X-ray, spirometry, EKG, blood work, and a complete history and physician examination by a study physician. Those who qualify for the study and agree via informed consent, will undergo a fiberoptic bronchoscopy on a separate day for the initial visit. Bronchoscopy is a procedure in which a flexible video instrument is passed via the nose or mouth, through the vocal cords and into the lungs. During the procedure, portions of the lungs will be washed ("lavaged") with a salt water solution, to collect the alveolar macrophages. This procedure involves conscious sedation, so that a driver is required on the day of the bronchoscopy. The entire procedure, including placement of an intravenous line to administer medications, local anesthetics, the bronchoscopy itself, and the recovery period, takes about 2.5-3 hours. The cells collected by bronchoscopy will be studied in the research laboratory, and used entirely in that procedure.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Fiberoptic bronchoscopy, blood draw, intravenous catheter
- Keywords
- macrophages, alveolar, monocytes, Receptor Protein-Tyrosine Kinases, Humans, Phagocytosis, Lung, in vitro
- 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.
Fiberoptic bronchoscopyProcedure or surgery
which a flexible video instrument is passed via the nose or mouth, through the vocal cords and into the lungs. During the procedure, portions of the lungs will be washed ("lavaged") with a salt water solution, to collect the alveolar macrophages. This procedure involves conscious sedation, so that a driver is required on the day of the bronchoscopy. The entire procedure, including placement of an intravenous line to administer medications, local anesthetics, the bronchoscopy itself, and the recovery period, takes about 2.5-3 hours.
blood drawProcedure or surgery
Blood will be collected at the enrollment visit to test the subject to exclude disorders that would make it unsafe to perform the bronchoscopy, including severe anemia, infection, or disorders of kidney or liver function.
intravenous catheterProcedure or surgery
Also called IV
An intravenous catheter is placed on the day of the bronchoscopy to permit administration of sedative medications.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | volunteer subjects Receives: Procedure: Fiberoptic bronchoscopy; Procedure: blood draw; Procedure: intravenous catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
macrophage uptake of apoptotic cells in vitro
Measured: 1-7 days
Secondary outcomes (1)
spirometric measurement of lung function
Measured: 1-30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2010 (estimated)
- Study startFeb 2010
- Primary completionJun 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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 only
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jeffrey L Curtis, MD, Principal investigator, VA Ann Arbor Healthcare System, Ann Arbor, MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01099410
- Sponsor's protocol ID
- Curtis 0015
- Status last verified
- Jan 2016
- First submitted
- 30 Mar 2010
- Last updated
- 6 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Bourdonnay E, Zaslona Z, Penke LR, Speth JM, Schneider DJ, Przybranowski S, Swanson JA, Mancuso P, Freeman CM, Curtis JL, Peters-Golden M. Transcellular delivery of vesicular SOCS proteins from macrophages to epithelial cells blunts inflammatory signaling. J Exp Med. 2015 May 4;212(5):729-42. doi: 10.1084/jem.20141675. Epub 2015 Apr 6.
PubMed 25847945Todt JC, Freeman CM, Brown JP, Sonstein J, Ames TM, McCubbrey AL, Martinez FJ, Chensue SW, Beck JM, Curtis JL. Smoking decreases the response of human lung macrophages to double-stranded RNA by reducing TLR3 expression. Respir Res. 2013 Mar 9;14(1):33. doi: 10.1186/1465-9921-14-33.
PubMed 23497334
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apoptotic Cell Ingestion by Normal Human Alveolar Macrophages
- ClinicalTrials.gov ID
- NCT01099410
- Acronym / sponsor ID
- Curtis 0015
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- macrophages, alveolar, monocytes, Receptor Protein-Tyrosine Kinases, Humans, Phagocytosis, Lung, in vitro
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Feb 2010
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 7 Apr 2010 (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 compare the ability of two types of white blood cells to eat dead host cells, and how this process affects their ability to protect the body from infection. The two cell types are monocytes, a cell in the bloodstream, and alveolar macrophages, a cell in the lung that is ultimately derived from monocytes
Detailed description
Volunteers, who may be Veterans or non-Veterans, will be screened by a series of questionnaires, chest X-ray, spirometry, EKG, blood work, and a complete history and physician examination by a study physician. Those who qualify for the study and agree via informed consent, will undergo a fiberoptic bronchoscopy on a separate day for the initial visit. Bronchoscopy is a procedure in which a flexible video instrument is passed via the nose or mouth, through the vocal cords and into the lungs. During the procedure, portions of the lungs will be washed ("lavaged") with a salt water solution, to collect the alveolar macrophages. This procedure involves conscious sedation, so that a driver is required on the day of the bronchoscopy. The entire procedure, including placement of an intravenous line to administer medications, local anesthetics, the bronchoscopy itself, and the recovery period, takes about 2.5-3 hours. The cells collected by bronchoscopy will be studied in the research laboratory, and used entirely in that procedure.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: Fiberoptic bronchoscopy, Procedure: blood draw, Procedure: intravenous cathetervolunteer subjects |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteer subjects recruited from the community; may be current or ex-smokers or never-smokers, but must be healthy enough to undergo research bronchoscopy safely.
Key inclusion criteria (2 listed)
- Veteran or non-Veteran
- Able to give informed consent
Key exclusion criteria (12 listed)
- Unstable heart disease
- Other systemic disease and unlikely to survive at least 2 years
- Mental incompetence
- Prednisone >20 mg/day
- Participation in another interventional protocol within last 6 weeks
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 |
|---|---|---|
| Fiberoptic bronchoscopywhich a flexible video instrument is passed via the nose or mouth, through the vocal cords and into the lungs. During the procedure, portions of the lungs will be washed ("lavaged") with a salt water solution, to collect the alveolar macrophages. This procedure involves conscious sedation, so that a driver is required on the day of the bronchoscopy. The entire procedure, including placement of an intravenous line to administer medications, local anesthetics, the bronchoscopy itself, and the recovery period, takes about 2.5-3 hours. | Procedure or surgery | Group 1 |
| blood drawBlood will be collected at the enrollment visit to test the subject to exclude disorders that would make it unsafe to perform the bronchoscopy, including severe anemia, infection, or disorders of kidney or liver function. | Procedure or surgery | Group 1 |
| intravenous catheterAlso: IVAn intravenous catheter is placed on the day of the bronchoscopy to permit administration of sedative medications. | Procedure or surgery | Group 1 |
Primary outcome
macrophage uptake of apoptotic cells in vitro
Time frame: 1-7 days
1 secondary outcome
spirometric measurement of lung function
Time frame: 1-30 days
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 6 Jan 2016.
- Results publication: PubMed 25847945Bourdonnay E, Zaslona Z, Penke LR, Speth JM, Schneider DJ, Przybranowski S, Swanson JA, Mancuso P, Freeman CM, Curtis JL, Peters-Golden M. Transcellular delivery of vesicular SOCS proteins from macrophages to epithelial cells blunts inflammatory signaling. J Exp Med. 2015 May 4;212(5):729-42. doi: 10.1084/jem.20141675. Epub 2015 Apr 6.
- Results publication: PubMed 23497334Todt JC, Freeman CM, Brown JP, Sonstein J, Ames TM, McCubbrey AL, Martinez FJ, Chensue SW, Beck JM, Curtis JL. Smoking decreases the response of human lung macrophages to double-stranded RNA by reducing TLR3 expression. Respir Res. 2013 Mar 9;14(1):33. doi: 10.1186/1465-9921-14-33.
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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.
Jeffrey L Curtis, MD principal investigator
VA Ann Arbor Healthcare System, Ann Arbor, MI
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, run by VA Office of Research and Development 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 12 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 6 Jan 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?
macrophage uptake of apoptotic cells in vitro (time frame: 1-7 days). 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 NCT01099410, which also lists 2 linked publications.
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 6 Jan 2016.