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Myeloid Suppressors in Inflammation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Richard Lockey, University of South Florida
ClinicalTrials.gov Identifier:
NCT01224223
First received: October 18, 2010
Last updated: June 27, 2012
Last verified: October 2010
History of Changes

October 18, 2010
June 27, 2012
October 2010
January 2012   (final data collection date for primary outcome measure)
To identify and characterize specific cell types (human dendritic cells, myeloid-derived suppressor cells and T lymphocytes) that are present in acute and chronic asthma. [ Time Frame: one year from start of study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01224223 on ClinicalTrials.gov Archive Site
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Myeloid Suppressors in Inflammation
Myeloid Suppressors in Inflammation

Myeloid-derived suppressor cells (MDSC) have been studied for their ability to suppress T cell responses in vivo and in vitro. As a result, MDSC can regulate cellular responses to chronic inflammatory conditions such as cancer, leading to the induction of tolerance and, ultimately, tumor escape from immune surveillance.
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Observational
Time Perspective: Prospective
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Probability Sample

Ages eligible for study: 18 to 60 years Genders eligible for study: male and female Signed and dated written informed consent is obtained prior to study blood draw.

Subjects being actively treated for chronic moderate to severe asthma based on National Heart Lung and Blood Institute guidelines (figure 1). Subjects must carry the diagnosis of asthma (made by a physician) for a minimum of six months.

Subjects within the first seven days of an acute asthma exacerbation, as determined by the referring physician.Able to give informed consent.
Asthma
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  • acute asthma exaecerbtion patients
    Patients experiencing acute exacerbation of their asthma
  • chronic asthma group
    Two groups are being enrolled. The first group is chronic asthma patients with FEV1 below 80% and FEV1/FVC ratio reduced by 5%
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
January 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion

  1. Ages eligible for study: 18 to 60 years
  2. Genders eligible for study: male and female
  3. Signed and dated written informed consent is obtained prior to study blood draw.
  4. Subjects being actively treated for chronic moderate to severe asthma based on National Heart Lung and Blood Institute guidelines (figure 1). Subjects must carry the diagnosis of asthma (made by a physician) for a minimum of six months.
  5. Subjects within the first seven days of an acute asthma exacerbation, as determined by the referring physician.
  6. Able to give informed consent.

Exclusion Criteria:

  1. Use of systemic corticosteroids within the previous two weeks.
  2. Pregnant and/or lactating females.
  3. Current tobacco use.
  4. Severe psychiatric illness.
  5. Current illicit substance abuse or dependence and/or abuse of alcohol.
  6. Current use of anti-microbial medications.
  7. Primary or secondary immunodeficiency.
  8. Any clinically significant uncontrolled medical condition that would put the patient's safety at risk.
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01224223
MYELOID
No
Richard Lockey, University of South Florida
University of South Florida
Not Provided
Principal Investigator: Richard Lockey, MD USF Asthma, Allergy and Immunology CRU
University of South Florida
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP