Cohort Study of the Patterns of Microvesicles in the Serum of Participants With Atopic and Non-atopic Asthma

Sponsor

Ohio State University (Other)

Overall Status

Completed

CT.gov ID

NCT00700726

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if a simple blood test can help in disease management, particularly asthma. This will be researched by looking at certain features of the blood and to compare asthmatics without allergies to those that have allergy-induced asthma.

Condition or Disease	Intervention/Treatment	Phase
Asthma Allergies

Detailed Description

A total of 20 participants (men or women) between the ages of 18-50 years with asthma will be enrolled. Participants will remain on their usual asthma treatments as prescribed by their usual asthma care provider. Current asthma treatments and any changes will be recorded at baseline and each subsequent visit. The primary outcome measures are correlation of microvesicle patterns with atopic state and variation from baseline with episodes of poor asthma control. Secondary outcomes include correlations between microvesicle patterns and spirometry, eNO levels, and glucorcorticoid sensitivity.

Study Design

Study Type:

Observational

Actual Enrollment :

26 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Study of the Patterns of Microvesicles in the Serum of Participants With Atopic and Non-atopic Asthma

Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
A. participants with atopic and non-atopic asthma

Outcome Measures

Primary Outcome Measures

correlation of microvesicle patterns with atopic state and variation from baseline with episodes of poor asthma control [6 months]

Secondary Outcome Measures

correlations between microvesicle patterns and spirometry, eNO levels, and glucorcorticoid sensitivity [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

be between the ages of 18 and 50.
have diagnosed asthma.
must have less "one pack per day for 10 years" smoking history

Exclusion Criteria:

You have had a fever of 100.4º within 24 hours of Visit 2.
You are enrolled in another interventional research trial.
Have other major chronic illnesses that would interfere with participation in the study.
You are pregnant.
You chronically use oral corticosteroids.
You have taken anti-coagulants, insulin, and any investigative drugs within 2 months.
You have the inability or unwillingness to provide consent.
Inability to perform aerobic exercise.
Inability to perform baseline measurements.
Less than 80% completion of screening period diaries.
Inability to be contacted by telephone.
Intention to move out of the area within 6 months.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Ohio State Univeristy Medical Center	Columbus	Ohio	United States	43210

Sponsors and Collaborators

Ohio State University

Investigators

Principal Investigator: Clay M. Marsh, MD, Ohio State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

John Mastronarde, MD, John Mastronarde M.D., Ohio State University

ClinicalTrials.gov Identifier:

NCT00700726

Other Study ID Numbers:

2007H0102

First Posted:

Jun 19, 2008

Last Update Posted:

Feb 13, 2014

Last Verified:

Feb 1, 2014

Keywords provided by John Mastronarde, MD, John Mastronarde M.D., Ohio State University

blood test

asthma

skin test

Additional relevant MeSH terms:

Asthma

Study Results

No Results Posted as of Feb 13, 2014