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

January 4, 2016 updated by: VA Office of Research and Development

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

17

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • VA Ann Arbor Healthcare System, Ann Arbor, MI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
macrophage uptake of apoptotic cells in vitro
Time Frame: 1-7 days
1-7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
spirometric measurement of lung function
Time Frame: 1-30 days
1-30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Jeffrey L Curtis, MD, VA Ann Arbor Healthcare System, Ann Arbor, MI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

March 30, 2010

First Submitted That Met QC Criteria

April 5, 2010

First Posted (Estimate)

April 7, 2010

Study Record Updates

Last Update Posted (Estimate)

January 6, 2016

Last Update Submitted That Met QC Criteria

January 4, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Curtis 0015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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