Intranasal Steroids and the Nasal Ocular Response | NCT00473915

Studies
Intranasal Steroids and the Nasal Ocular Response

NCT00473915

Sponsor

University of Chicago

Status

Completed

Last Update Posted

Jun 3, 2013Estimated

Enrollment

20Estimated

Phase

Phase 4

Conditions

Seasonal Allergic Rhinitis

Interventions

fluticasone furoate

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2013

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

Apr 2007

Primary Completion Date

Dec 2007Actual

Completion Date

Feb 2008Actual

First Submitted Date

May 14, 2007

First Submission Date that Met QC Criteria

May 14, 2007

First Posted Date

May 16, 2007Estimated

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

May 30, 2013

Last Update Posted Date

Jun 3, 2013Estimated

Name	Class
GlaxoSmithKline	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

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

Eye symptoms of tearing, redness and itch frequently occur in patients with allergic rhinitis or hayfever. The purpose of this study is to learn whether placing allergen (the substance that causes allergies) in the nose several days in a row will cause an increase in eye symptoms and whether receiving a nasal steroid spray will prevent these eye symptoms.

Detailed Description

Not provided

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

20Estimated

Name	Type	Description	Arm Group Labels	Other Names
fluticasone furoate	Drug	corticosteroid nasal spray

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in ocular symptoms		between days 1 and 3

Secondary Outcomes

Measure	Description	Time Frame
number of eosinophils		between days 1 and 3

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Males and females between 18 and 45 years of age.
History of grass and/or ragweed allergic rhinitis.
Positive skin test to grass and/or ragweed antigen.
Positive response to screening nasal challenge.

Exclusion Criteria

Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
Pregnant or lactating women.
Upper respiratory infection within 14 days of study start.

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
Robert m Naclerio, MD	University of Chicago	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Chicago		Chicago	Illinois	60637	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19428097	Derived	Baroody FM, Shenaq D, DeTineo M, Wang J, Naclerio RM. Fluticasone furoate nasal spray reduces the nasal-ocular reflex: a mechanism for the efficacy of topical steroids in controlling allergic eye symptoms. J Allergy Clin Immunol. 2009 Jun;123(6):1342-8. doi: 10.1016/j.jaci.2009.03.015. Epub 2009 May 9.

ID	Term
D065631	Rhinitis, Allergic
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases