Back to resultsUtility of Versican and Hyaluronan Measurement in Induced Sputum as Biomarkers of Asthma
Primary Purpose
Allergic Asthma
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Inhaled corticosteroid (fluticasone)
Sponsored by
About this trial
This is an interventional diagnostic trial for Allergic Asthma focused on measuring versican, hyaluronan, sputum
Eligibility Criteria
Inclusion Criteria:
- Allergic asthma defined as a positive methacholine challenge
Exclusion Criteria:
- Non-atopic patients
Sites / Locations
- Associated Scientists to Help Minimize Allergies
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
inhaled corticosteroid
Arm Description
All asthmatics will start inhaled corticosteroids.
Outcomes
Primary Outcome Measures
Compare hyaluronan and versican in asthmatics versus atopic non-asthmatics.
Secondary Outcome Measures
Full Information
NCT ID
NCT00980707
First Posted
September 17, 2009
Last Updated
January 18, 2012
Sponsor
Associated Scientists to Help Minimize Allergies
Collaborators
Benaroya Research Institute, GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT00980707
Brief Title
Utility of Versican and Hyaluronan Measurement in Induced Sputum as Biomarkers of Asthma
Official Title
Utility of Versican and Hyaluronan Measurement in Induced Sputum as Biomarker of Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Associated Scientists to Help Minimize Allergies
Collaborators
Benaroya Research Institute, GlaxoSmithKline
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine the role of versican and hyaluronan measurements in induced sputum as biomarkers of asthma. Enroll 10 subjects with mild persistent asthma who are not receiving treatment with a controller therapy.
Detailed Description
We will compare spirometry, eNO and sputum measurements of versican and hyaluronan before and after treatment with fluticasone 220 ug/bid.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Asthma
Keywords
versican, hyaluronan, sputum
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
inhaled corticosteroid
Arm Type
Experimental
Arm Description
All asthmatics will start inhaled corticosteroids.
Intervention Type
Drug
Intervention Name(s)
Inhaled corticosteroid (fluticasone)
Other Intervention Name(s)
fluticasone
Intervention Description
inhaled fluticasone 220 ug/bid
Primary Outcome Measure Information:
Title
Compare hyaluronan and versican in asthmatics versus atopic non-asthmatics.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Allergic asthma defined as a positive methacholine challenge
Exclusion Criteria:
Non-atopic patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonard C Altman, MD
Organizational Affiliation
Associated Scientists to Help Minimize Allergies
Official's Role
Principal Investigator
Facility Information:
Facility Name
Associated Scientists to Help Minimize Allergies
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Utility of Versican and Hyaluronan Measurement in Induced Sputum as Biomarkers of Asthma
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