Once-Daily Investigational Nasal Spray In Adults And Adolescents With Perennial Allergic Rhinitis (PAR)

NCT ID: NCT00289198

Last Updated: 2018-04-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

301 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-07

Study Completion Date

2006-07-04

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 6 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

Study Groups

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Fluticasone furoate

Participants were instructed to administer two sprays into each nostril once daily every morning of fluticasone furoate 110 μg

Group Type EXPERIMENTAL

FF

Intervention Type DRUG

fluticasone furoate 110 μg nasal spray

Placebo

Participants were instructed to administer two sprays into each nostril once daily every morning of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo nasal spray

Interventions

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FF

fluticasone furoate 110 μg nasal spray

Intervention Type DRUG

Placebo

placebo nasal spray

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 and other identified medications during the study.
* Current tobacco use or tobacco use within the past year.
* Exposure to an investigational study drug within the past 12 months.
* Clinically significant abnormal electrocardiograms (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

San Diego, California, United States

Site Status

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Baltimore, Maryland, United States

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Wheaton, Maryland, United States

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North Dartmouth, Massachusetts, United States

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Minneapolis, Minnesota, United States

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Canton, Ohio, United States

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Providence, Rhode Island, United States

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South Burlington, Vermont, United States

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Camperdown, New South Wales, Australia

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Kippa-Ring, Queensland, Australia

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Toorak Gardens, South Australia, Australia

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Clayton, Victoria, Australia

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Melbourne, Victoria, Australia

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Parkville, Victoria, Australia

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Nedlands, Western Australia, Australia

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Mississauga, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Trois-Rivières, Quebec, Canada

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Tallinn, , Estonia

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Tartu, , Estonia

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Schwerin, Mecklenburg-Vorpommern, Germany

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Berlin, , Germany

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Berlin, , Germany

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Hamburg, , Germany

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Dobele, , Latvia

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Liepāja, , Latvia

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Riga, , Latvia

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Riga, , Latvia

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Tukums, , Latvia

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Kaunas, , Lithuania

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Šiauliai, , Lithuania

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Vilnius, , Lithuania

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Vilnius, , Lithuania

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Vilnius, , Lithuania

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Auckland, , New Zealand

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Auckland, , New Zealand

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Grafton, , New Zealand

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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GSK Investigational Site

Saint Petersburg, , Russia

Site Status

Countries

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United States Australia Canada Estonia Germany Latvia Lithuania New Zealand Russia

Study Documents

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Document Type: Dataset Specification

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: 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: 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: Informed Consent Form

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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FFR106080

Identifier Type: -

Identifier Source: org_study_id

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