Apoptotic Cell (AC) Uptake by Human Alveolar Macrophages (AM)

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Apoptotic Cell Ingestion by Normal Human Alveolar Macrophages

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01099410
• Other study ID #: Curtis 0015
• Status: Completed
• Phase: N/A
• First received: March 30, 2010
• Last updated: January 4, 2016
• Start date: February 2010
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical 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. 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Veteran or non-Veteran

• Able to give informed consent

Exclusion Criteria:

• 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

• 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Procedure:
• Fiberoptic bronchoscopy
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 draw
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 catheter
An intravenous catheter is placed on the day of the bronchoscopy to permit administration of sedative medications.

Locations

Country	Name	City	State
United States	VA Ann Arbor Healthcare System, Ann Arbor, MI	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 — View Citation

Todt 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;14:33. doi: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	macrophage uptake of apoptotic cells in vitro		1-7 days	No
Secondary	spirometric measurement of lung function		1-30 days	No

External Links

•   Click here for more information about this study: Apoptotic cell ingestion by normal human alveolar macrophages