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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
  Purpose

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.


Condition
Asthma

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Myeloid Suppressors in Inflammation

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: October 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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%

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01224223

Locations
United States, Florida
USF Asthma, Allergy and Immunology CRU
Tampa, Florida, United States, 33613
Sponsors and Collaborators
University of South Florida
Investigators
Principal Investigator: Richard Lockey, MD USF Asthma, Allergy and Immunology CRU
  More Information

No publications provided

Responsible Party: Richard Lockey, principal investigator, University of South Florida
ClinicalTrials.gov Identifier: NCT01224223     History of Changes
Other Study ID Numbers: MYELOID
Study First Received: October 18, 2010
Last Updated: June 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of South Florida:
asthma

Additional relevant MeSH terms:
Asthma
Inflammation
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013