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

Sponsor:	Ohio State University
Information provided by:	Ohio State University
ClinicalTrials.gov Identifier:	NCT00700726

Purpose

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
Asthma Allergies

Study Type:	Observational
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Allergy Asthma

U.S. FDA Resources

Further study details as provided by Ohio State University:

Primary Outcome Measures:

correlation of microvesicle patterns with atopic state and variation from baseline with episodes of poor asthma control [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

correlations between microvesicle patterns and spirometry, eNO levels, and glucorcorticoid sensitivity [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

blood, nasal lavage (optional)

Estimated Enrollment:	20
Study Start Date:	June 2008
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts
A. participants with atopic and non-atopic asthma

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.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

primary care clinic

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00700726

Contacts

Contact: Clay B. Marsh, MD	614-293-4978	clay.marsh@osumc.edu
Contact: Janice E. Drake, CRTT	614-366-2287	janice.drake@osumc.edu

Locations

United States, Ohio
The Ohio State Univeristy Medical Center	Recruiting
Columbus, Ohio, United States, 43210
Contact: Janice E. Drake, CRTT 614-366-2287 janice.drake@osumc.edu
Contact: Sharon Cheung, BS 614-366-2258 sharon.cheung@osumc.edu
Principal Investigator: Clay B. Marsh, MD

Sponsors and Collaborators

Ohio State University

Investigators

Principal Investigator:

Clay M. Marsh, MD

Ohio State University

More Information

No publications provided

Responsible Party:	John G. Mastronarde M.D., The Ohio State University
ClinicalTrials.gov Identifier:	NCT00700726 History of Changes
Other Study ID Numbers:	2007H0102
Study First Received:	June 17, 2008
Last Updated:	August 16, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Ohio State University:

blood test
asthma
skin test

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases

Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012