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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00700726
• Other study ID #: 2007H0102
• Status: Completed
• Phase: N/A
• First received: June 17, 2008
• Last updated: February 11, 2014
• Start date: June 2008
• Est. completion date: December 2013

Study information

• Verified date: February 2014
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Allergies
• Asthma

Locations

Country	Name	City	State
United States	The Ohio State Univeristy Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	correlation of microvesicle patterns with atopic state and variation from baseline with episodes of poor asthma control		6 months	No
Secondary	correlations between microvesicle patterns and spirometry, eNO levels, and glucorcorticoid sensitivity		6 months	No