NCT00980707

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 21, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

January 19, 2012

Status Verified

January 1, 2012

Enrollment Period

10 months

First QC Date

September 17, 2009

Last Update Submit

January 18, 2012

Conditions

Allergic Asthma

Keywords

versicanhyaluronansputum

Outcome Measures

Primary Outcomes (1)

  • Compare hyaluronan and versican in asthmatics versus atopic non-asthmatics.

    1 year

Study Arms (1)

inhaled corticosteroid

EXPERIMENTAL

All asthmatics will start inhaled corticosteroids.

Drug: Inhaled corticosteroid (fluticasone)

Interventions

Inhaled corticosteroid (fluticasone)DRUG

inhaled fluticasone 220 ug/bid

Also known as: fluticasone
inhaled corticosteroid

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Allergic asthma defined as a positive methacholine challenge

You may not qualify if:

  • Non-atopic patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Associated Scientists to Help Minimize Allergies

Seattle, Washington, 98105, United States

Location

MeSH Terms

Interventions

Fluticasone

Intervention Hierarchy (Ancestors)

AndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Leonard C Altman, MD

    Associated Scientists to Help Minimize Allergies

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2009

First Posted

September 21, 2009

Study Start

August 1, 2009

Primary Completion

June 1, 2010

Study Completion

November 1, 2010

Last Updated

January 19, 2012

Record last verified: 2012-01

Locations

US(1)