Myeloid Suppressors in Inflammation

NCT ID: NCT01224223

Last Updated: 2012-06-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-01-31

Brief Summary

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.

Conditions

Asthma

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

acute asthma exaecerbtion patients

Patients experiencing acute exacerbation of their asthma

No interventions assigned to this group

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%

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of South Florida

OTHER

Sponsor Role: lead

Responsible Party

Richard Lockey

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard Lockey, MD

Role: PRINCIPAL_INVESTIGATOR

USF Asthma, Allergy and Immunology CRU

Locations

USF Asthma, Allergy and Immunology CRU

Tampa, Florida, United States

Countries

United States

Other Identifiers

MYELOID

Identifier Type: -

Identifier Source: org_study_id