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

NCT ID: NCT00700726

Last Updated: 2014-02-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 26 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2013-12-31

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.

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.

Conditions

Asthma; Allergies

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

A.

participants with atopic and non-atopic asthma

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

John Mastronarde, MD

John Mastronarde M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Clay M. Marsh, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State Univeristy Medical Center

Columbus, Ohio, United States

Countries

United States

Other Identifiers

2007H0102

Identifier Type: -

Identifier Source: org_study_id