ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00700726
Recruitment Status : Completed
First Posted : June 19, 2008
Last Update Posted : February 13, 2014
Sponsor:
Information provided by (Responsible Party):
John Mastronarde, MD, Ohio State University

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.

Condition or disease
Asthma Allergies

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.

Study Type : Observational
Actual Enrollment : 26 participants
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
Study Start Date : June 2008
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Group/Cohort
A.
participants with atopic and non-atopic asthma



Primary Outcome Measures :
  1. correlation of microvesicle patterns with atopic state and variation from baseline with episodes of poor asthma control [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. correlations between microvesicle patterns and spirometry, eNO levels, and glucorcorticoid sensitivity [ Time Frame: 6 months ]

Biospecimen Retention:   Samples Without DNA
blood, nasal lavage (optional)


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00700726


Locations
United States, Ohio
The Ohio State Univeristy Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: Clay M. Marsh, MD Ohio State University

Responsible Party: John Mastronarde, MD, John Mastronarde M.D., Ohio State University
ClinicalTrials.gov Identifier: NCT00700726     History of Changes
Other Study ID Numbers: 2007H0102
First Posted: June 19, 2008    Key Record Dates
Last Update Posted: February 13, 2014
Last Verified: February 2014

Keywords provided by John Mastronarde, MD, 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