Myeloid Suppressors in Inflammation

Asthma Clinical Trial

Official title:

Myeloid Suppressors in Inflammation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01224223
• Other study ID #: MYELOID
• Status: Completed
• Phase: N/A
• First received: October 18, 2010
• Last updated: June 27, 2012
• Start date: October 2010
• Est. completion date: January 2012

Study information

• Verified date: October 2010
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
United States	USF Asthma, Allergy and Immunology CRU	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		one year from start of study	No