NCT01099410

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 7, 2010

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 6, 2016

Status Verified

January 1, 2016

Enrollment Period

5.3 years

First QC Date

March 30, 2010

Last Update Submit

January 4, 2016

Conditions

Keywords

macrophages, alveolarmonocytesReceptor Protein-Tyrosine KinasesHumansPhagocytosisLungin vitro

Outcome Measures

Primary Outcomes (1)

  • macrophage uptake of apoptotic cells in vitro

    1-7 days

Secondary Outcomes (1)

  • spirometric measurement of lung function

    1-30 days

Study Arms (1)

Group 1

volunteer subjects

Procedure: Fiberoptic bronchoscopyProcedure: blood drawProcedure: intravenous catheter

Interventions

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.

Group 1
blood drawPROCEDURE

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.

Group 1

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

Also known as: IV
Group 1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Veteran or non-Veteran
  • Able to give informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105, United States

Location

Related 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. J Exp Med. 2015 May 4;212(5):729-42. doi: 10.1084/jem.20141675. Epub 2015 Apr 6.

  • 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(1):33. doi: 10.1186/1465-9921-14-33.

Biospecimen

Retention: NONE RETAINED

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

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Jeffrey L Curtis, MD

    VA Ann Arbor Healthcare System, Ann Arbor, MI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2010

First Posted

April 7, 2010

Study Start

February 1, 2010

Primary Completion

June 1, 2015

Study Completion

December 1, 2015

Last Updated

January 6, 2016

Record last verified: 2016-01

Locations