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

Sponsored by:	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

MedlinePlus related topics: Allergy Asthma

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Study of the Patterns of Microvesicles in the Serum of Participants With Atopic and Non-Atopic Asthma

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

Biospecimen Description:

blood, nasal lavage (optional)

Estimated Enrollment:	20
Study Start Date:	June 2008
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	June 2010 (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:	The Ohio State University ( Clay B. Marsh )
Study ID Numbers:	2007H0102
Study First Received:	June 17, 2008
Last Updated:	December 30, 2008
ClinicalTrials.gov Identifier:	NCT00700726 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Ohio State University:

blood test
asthma
skin test

Study placed in the following topic categories:

Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Bronchial Diseases

Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Hypersensitivity
Lung Diseases, Obstructive
Immune System Diseases
Respiratory Tract Diseases
Bronchial Diseases

Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on May 07, 2009