ClinicalTrials.gov
ClinicalTrials.gov Menu

Utility of Versican and Hyaluronan Measurement in Induced Sputum as Biomarkers of 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: NCT00980707
Recruitment Status : Completed
First Posted : September 21, 2009
Last Update Posted : January 19, 2012
Sponsor:
Collaborators:
Benaroya Research Institute
GlaxoSmithKline
Information provided by (Responsible Party):
Associated Scientists to Help Minimize Allergies

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.

Condition or disease Intervention/treatment Phase
Allergic Asthma Drug: Inhaled corticosteroid (fluticasone) Phase 4

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  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Utility of Versican and Hyaluronan Measurement in Induced Sputum as Biomarker of Asthma
Study Start Date : August 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : November 2010


Arm Intervention/treatment
Experimental: inhaled corticosteroid
All asthmatics will start inhaled corticosteroids.
Drug: Inhaled corticosteroid (fluticasone)
inhaled fluticasone 220 ug/bid
Other Name: fluticasone




Primary Outcome Measures :
  1. Compare hyaluronan and versican in asthmatics versus atopic non-asthmatics. [ Time Frame: 1 year ]


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 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Allergic asthma defined as a positive methacholine challenge

Exclusion Criteria:

  • Non-atopic patients

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): NCT00980707


Locations
United States, Washington
Associated Scientists to Help Minimize Allergies
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Associated Scientists to Help Minimize Allergies
Benaroya Research Institute
GlaxoSmithKline
Investigators
Principal Investigator: Leonard C Altman, MD Associated Scientists to Help Minimize Allergies

Responsible Party: Associated Scientists to Help Minimize Allergies
ClinicalTrials.gov Identifier: NCT00980707     History of Changes
Other Study ID Numbers: AI-005 versican
First Posted: September 21, 2009    Key Record Dates
Last Update Posted: January 19, 2012
Last Verified: January 2012

Keywords provided by Associated Scientists to Help Minimize Allergies:
versican
hyaluronan
sputum

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Hyaluronic Acid
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adjuvants, Immunologic
Immunologic Factors
Viscosupplements
Protective Agents