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

NCT00700726 | Completed DMC

• 1 other identifier: 2007H0102
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Allergies

Keywords

blood test; asthma; skin test

Outcome Measures

Primary Outcomes (1)

• correlation of microvesicle patterns with atopic state and variation from baseline with episodes of poor asthma control

  6 months

Secondary Outcomes (1)

• correlations between microvesicle patterns and spirometry, eNO levels, and glucorcorticoid sensitivity

  6 months

Study Arms (1)

A.

participants with atopic and non-atopic asthma

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

primary care clinic

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State Univeristy Medical Center

Columbus, Ohio, 43210, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood, nasal lavage (optional)

MeSH Terms

Conditions

Asthma; Hypersensitivity

Condition Hierarchy (Ancestors)

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

Study Officials

• Clay M. Marsh, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: John Mastronarde M.D.

Study Record Dates

• First Submitted: June 17, 2008
• First Posted: June 19, 2008
• Study Start: June 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 13, 2014

Record last verified: 2014-02

Locations

US (1)