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Completed

NCT Number: NCT01099410

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

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fiberoptic bronchoscopy

Procedure

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

Procedure

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

Procedure

An intravenous catheter is placed on the day of the bronchoscopy to permit administration of sedative medications.

Other names: IV

Primary outcomes

  1. macrophage uptake of apoptotic cells in vitro

    Time frame: 1-7 days

Secondary outcomes

  1. spirometric measurement of lung function

    Time frame: 1-30 days

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Apoptotic Cell Ingestion by Normal Human Alveolar Macrophages

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Apr 7, 2010
Registry last updated
Jan 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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