Study of T-Regulatory Cells in Asthma

Asthma Clinical Trial

Official title:

Study of T-Regulatory Cells in Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02574351
• Other study ID #: 11-076B
• Status: Completed
• Phase: N/A
• First received: November 1, 2013
• Last updated: January 28, 2016
• Start date: May 2011
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

To study whether the immune response as directed by regulatory T cells is different between obese asthmatics, normal weight asthmatics and healthy controls.

Description:

The investigators hypothesize that the increase in asthma severity in obese patients is, at least in part, related to a defective number or function of regulatory T cells (Tregs). That is in the obese asthmatic subject a defective Treg profile would augment the inflammation of asthma (a synergistic effect). Alternatively, that Treg dysfunction in obesity might affect asthma independently (an additive effect). To test these hypotheses, the investigators plan to conduct an observational controlled study to compare Treg profile in obese and normal-weight individuals with and without asthma.

This is an exploratory study to investigate the following:

1. To determine whether Treg number and function differs between obese and normal-weight individuals with and without asthma.

2. To determine whether serum leptin levels differ between obese and normal-weight individuals with and without asthma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Obese asthmatics

2. Normal weight asthmatics

3. Healthy obese

4. Health non-obese

Asthmatic subjects will be recruited:

1. If they have a physician diagnosis of adult onset asthma (asthma diagnosed after the age of 18).

2. If they have stable disease without exacerbation, physician or emergency department visits, or change in asthma medication for the past 4 weeks, inhaled steroids will be allowed.

Non asthmatic subjects

1. Will not have had a prior diagnosis of asthma,

2. Have no history of atopy.

3. Have no history of lung diseases.

Exclusion Criteria:

1. > 10 pack year smoking history, or currently smoking

2. Pulmonary disease other than asthma.

3. History of heart disease

4. Weight loss greater than 10 kg, or greater than 10% initial body weight within the past 3 months.

5. Any agents that could potentially alter the in?ammatory system such as thiazolidinedione, a statin, or oral steroid therapy.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma

Intervention

Biological:
• blood draw, breathing test
A blood draw,breathing test will be performed on every participant

Locations

Country	Name	City	State
United States	North Shore LIJ Health System	New Hyde Park	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference of treg and serum leptin levels among obese and normal weight individuals with and without asthma.		3 years	No