Utility of Versican and Hyaluronan Measurement in Induced Sputum as Biomarkers of Asthma

January 18, 2012 updated by: Associated Scientists to Help Minimize Allergies

Utility of Versican and Hyaluronan Measurement in Induced Sputum as Biomarker of Asthma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We will compare spirometry, eNO and sputum measurements of versican and hyaluronan before and after treatment with fluticasone 220 ug/bid.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98105
        • Associated Scientists to Help Minimize Allergies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Allergic asthma defined as a positive methacholine challenge

Exclusion Criteria:

  • Non-atopic patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: inhaled corticosteroid
All asthmatics will start inhaled corticosteroids.
Drug: Inhaled corticosteroid (fluticasone)
inhaled fluticasone 220 ug/bid
Other Names:
  • fluticasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Compare hyaluronan and versican in asthmatics versus atopic non-asthmatics.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Associated Scientists to Help Minimize Allergies

Collaborators

GlaxoSmithKline
Benaroya Research Institute

Investigators

  • Principal Investigator: Leonard C Altman, MD, Associated Scientists to Help Minimize Allergies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

September 17, 2009

First Submitted That Met QC Criteria

September 18, 2009

First Posted (Estimate)

September 21, 2009

Study Record Updates

Last Update Posted (Estimate)

January 19, 2012

Last Update Submitted That Met QC Criteria

January 18, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI-005 versican

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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