A Study To Evaluate The Efficacy And Safety Of A Once-Daily Investigational Nasal Spray In Adults And Adolescents With Perennial Allergic Rhinitis (PAR).

NCT ID: NCT00103454

Last Updated: 2016-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

288 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2005-05-31

Brief Summary

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The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with perennial allergic rhinitis (PAR).

Detailed Description

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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 4 Weeks in Adult and Adolescent Subjects (12 years of age and older) with Perennial Allergic Rhinitis (PAR)

Conditions

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Rhinitis, Allergic, Perennial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1

Group Type EXPERIMENTAL

GW685698X

Intervention Type DRUG

Interventions

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GW685698X

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of perennial allergic rhinitis (PAR).
* Must comply with study procedures and be literate.

Exclusion Criteria

* Significant concomitant medical conditions.
* Use of corticosteroids.
* Use of allergy medications and some other medications during the study.
* Current tobacco use.
* Clinically significant abnormal ECG or laboratory abnormality.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Little Rock, Arkansas, United States

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Los Angeles, California, United States

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Mission Viejo, California, United States

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Orange, California, United States

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San Diego, California, United States

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San Diego, California, United States

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Colorado Springs, Colorado, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Tallahassee, Florida, United States

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Tampa, Florida, United States

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Vero Beach, Florida, United States

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Lawrenceville, Georgia, United States

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Lilburn, Georgia, United States

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South Bend, Indiana, United States

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Metairie, Louisiana, United States

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Portland, Maine, United States

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Baltimore, Maryland, United States

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Rockville, Maryland, United States

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North Andover, Massachusetts, United States

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North Dartmouth, Massachusetts, United States

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Springfield, Massachusetts, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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Lincoln, Nebraska, United States

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Omaha, Nebraska, United States

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Ocean City, New Jersey, United States

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Summit, New Jersey, United States

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Raleigh, North Carolina, United States

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Canton, Ohio, United States

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Cincinnati, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Eugene, Oregon, United States

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Lake Oswego, Oregon, United States

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Medford, Oregon, United States

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Providence, Rhode Island, United States

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Orangeburg, South Carolina, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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New Braunfels, Texas, United States

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Murray, Utah, United States

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South Burlington, Vermont, United States

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West Allis, Wisconsin, United States

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Kelowna, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Mississauga, Ontario, Canada

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Ottawa, Ontario, Canada

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Québec, Quebec, Canada

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Saskatoon, Saskatchewan, Canada

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Countries

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United States Canada

References

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Nathan R, Berger W, Yang W, Cheema A, Silvey MJ, Wu W, Faris M, Philpot E. Once daily fluticasone furoate* nasal spray (FFNS), a novel enhanced affinity steroid, provides 24-hour relief for the nasal symptoms of perennial allergic rhinitis (PAR) J Allergy

Reference Type RESULT

Nathan RA, Berger W, Yang W, Cheema A, Silvey M, Wu W, Philpot E. Effect of once-daily fluticasone furoate nasal spray on nasal symptoms in adults and adolescents with perennial allergic rhinitis. Ann Allergy Asthma Immunol. 2008 May;100(5):497-505. doi: 10.1016/S1081-1206(10)60477-2.

Reference Type DERIVED
PMID: 18517084 (View on PubMed)

Study Documents

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Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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FFR30002

Identifier Type: -

Identifier Source: org_study_id

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