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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01099410
First received: March 30, 2010
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention
Chronic Obstructive Pulmonary Disease
Procedure: Fiberoptic bronchoscopy
Procedure: blood draw
Procedure: intravenous catheter

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Apoptotic Cell Ingestion by Normal Human Alveolar Macrophages

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • macrophage uptake of apoptotic cells in vitro [ Time Frame: 1-7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • spirometric measurement of lung function [ Time Frame: 1-30 days ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

whole blood, white blood cells, serum, bronchoalveolar lavage fluid


Estimated Enrollment: 33
Study Start Date: February 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
volunteer subjects
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.
Procedure: 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.
Procedure: intravenous catheter
An intravenous catheter is placed on the day of the bronchoscopy to permit administration of sedative medications.
Other Name: IV

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01099410

Locations
United States, Michigan
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
Investigators
Principal Investigator: Jeffrey L Curtis, MD VA Ann Arbor Healthcare System
  More Information

Additional Information:
No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01099410     History of Changes
Other Study ID Numbers: Curtis 0015
Study First Received: March 30, 2010
Last Updated: August 26, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
macrophages, alveolar
monocytes
Receptor Protein-Tyrosine Kinases
Humans
Phagocytosis
Lung
in vitro

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 18, 2014