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

This study has been completed.
Sponsor:
Collaborators:
Benaroya Research Institute
GlaxoSmithKline
Information provided by (Responsible Party):
Associated Scientists to Help Minimize Allergies
ClinicalTrials.gov Identifier:
NCT00980707
First received: September 17, 2009
Last updated: January 18, 2012
Last verified: January 2012
  Purpose

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 Intervention Phase
Allergic Asthma
Drug: Inhaled corticosteroid (fluticasone)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Utility of Versican and Hyaluronan Measurement in Induced Sputum as Biomarker of Asthma

Resource links provided by NLM:


Further study details as provided by Associated Scientists to Help Minimize Allergies:

Primary Outcome Measures:
  • Compare hyaluronan and versican in asthmatics versus atopic non-asthmatics. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: August 2009
Study Completion Date: November 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: inhaled corticosteroid
All asthmatics will start inhaled corticosteroids.
Drug: Inhaled corticosteroid (fluticasone)
inhaled fluticasone 220 ug/bid
Other Name: fluticasone

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Allergic asthma defined as a positive methacholine challenge

Exclusion Criteria:

  • Non-atopic patients
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Associated Scientists to Help Minimize Allergies
ClinicalTrials.gov Identifier: NCT00980707     History of Changes
Other Study ID Numbers: AI-005 versican
Study First Received: September 17, 2009
Last Updated: January 18, 2012
Health Authority: United States: Institutional Review Board

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
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on September 22, 2014