Utility of Versican and Hyaluronan Measurement in Induced... | NCT00980707

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

NCT00980707

Sponsor

Associated Scientists to Help Minimize Allergies

Status

Completed

Last Update Posted

Jan 19, 2012Estimated

Enrollment

10Actual

Phase

Phase 4

Conditions

Allergic Asthma

Interventions

Inhaled corticosteroid (fluticasone)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Jun 2010Actual

Completion Date

Nov 2010Actual

First Submitted Date

Sep 17, 2009

First Submission Date that Met QC Criteria

Sep 18, 2009

First Posted Date

Sep 21, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 18, 2012

Last Update Posted Date

Jan 19, 2012Estimated

Name	Class
Benaroya Research Institute	OTHER
GlaxoSmithKline	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
inhaled corticosteroid	Experimental	All asthmatics will start inhaled corticosteroids.	Drug: Inhaled corticosteroid (fluticasone)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Inhaled corticosteroid (fluticasone)	Drug	inhaled fluticasone 220 ug/bid	inhaled corticosteroid

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Allergic asthma defined as a positive methacholine challenge

Exclusion Criteria:

Non-atopic patients

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Leonard C Altman, MD	Associated Scientists to Help Minimize Allergies	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Associated Scientists to Help Minimize Allergies		Seattle	Washington	98105	United States

Type	Date	Date Unknown
Release	Jul 13, 2012
Unrelease		Yes
Release	Jul 20, 2012
Unrelease		Yes

Submission Tracking

Estimated Results First Submitted Date

Jul 13, 2012

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jul 13, 2012		Yes
Jul 20, 2012

Intervention Browse Module

MeSH Terms

ID	Term
D000068298	Fluticasone

Ancestor Terms

ID	Term
D000730	Androstadienes
D000736	Androstenes
D000731	Androstanes
D013256	Steroids
D000072473

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Browse Branches

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