Perennial Allergic Rhinitis Study In Pediatric Subjects

NCT ID: NCT00108914

Last Updated: 2017-01-19

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

558 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2005-11-30

Brief Summary

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The purpose of this study is to determine if the investigational drug is effective and safe in children with perennial allergic rhinitis.

Detailed Description

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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 50mcg and 100mcg for 12 Weeks in Pediatric Subjects Ages 2 to \<12 Years 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

Interventions

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GW685698X

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of perennial allergic rhinitis.

Exclusion Criteria

* Have significant concomitant medical conditions.
* Use of corticosteroids or other allergy medications during the study.
* Have abnormal ECG.
* Have laboratory abnormality.
* Have abnormal eye exam.
Minimum Eligible Age

2 Years

Maximum 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

Costa Mesa, California, United States

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Cudahy, California, United States

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Long Beach, California, United States

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Long Beach, California, United States

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Orange, California, United States

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Riverside, California, United States

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Sacramento, 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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Walnut Creek, California, United States

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Denver, Colorado, United States

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Denver, Colorado, United States

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Englewood, Colorado, United States

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Coral Gables, Florida, United States

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Gainesville, Georgia, United States

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Lawrenceville, Georgia, United States

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Stockbridge, Georgia, United States

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Metairie, Louisiana, United States

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Shreveport, Louisiana, United States

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Baltimore, Maryland, United States

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Ypsilanti, Michigan, United States

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Jackson, Mississippi, United States

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Kansas City, Missouri, United States

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Omaha, Nebraska, United States

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Omaha, Nebraska, United States

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Brick, New Jersey, United States

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Ithaca, New York, United States

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Liverpool, New York, United States

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Rochester, New York, United States

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Rochester, New York, United States

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Utica, New York, United States

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Raleigh, North Carolina, United States

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Cincinnati, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Lake Oswego, Oregon, United States

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Medford, Oregon, United States

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Bellevue, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Upland, Pennsylvania, United States

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Charleston, South Carolina, United States

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Knoxville, Tennessee, United States

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Nashville, Tennessee, United States

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El Paso, Texas, United States

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Buenos Aires, Buenos Aires, Argentina

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Nueve de Julio, Buenos Aires, Argentina

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Rosario, Santa Fe Province, Argentina

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Santa Fe, Santa Fe Province, Argentina

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Viña del Mar, Región de Valparaíso, Chile

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Santiago, Región Metro de Santiago, Chile

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Joensuu, , Finland

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Nokia, , Finland

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Tampere, , Finland

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Turku, , Finland

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Napoli, Campania, Italy

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Bari, , Italy

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Milan, , Italy

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Monticelli Ascoli Piceno, , Italy

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Perugia, , Italy

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Salerno, , Italy

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México, , Mexico

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México, , Mexico

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Monterrey, N.L, , Mexico

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Banská Bystrica, , Slovakia

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Bratislava, , Slovakia

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Levoča, , Slovakia

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Nitra, , Slovakia

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Countries

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United States Argentina Chile Finland Italy Mexico Slovakia

References

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Máspero J, Rosenblut A, Finn A, J Lim J, Wu W, Philpot E. Safety of fluticasone furoate* nasal spray in children with perennial allergic rhinitis (*USAN approved name). Allergy 2007;62(Suppl. 83): 381 (abstract).

Reference Type RESULT

Máspero JF, Rosenblut A, Finn A, Lim J, Wu W, Faris M, Philpot E. Once-daily fluticasone furoate nasal spray (FF) is safe and effective in the long-term treatment of perennial allergic rhinitis (PAR) in children ages 2 to 11 years. J Allergy Clin Immunol.

Reference Type RESULT

Maspero JF, Rosenblut A, Finn A Jr, Lim J, Wu W, Philpot E. Safety and efficacy of fluticasone furoate in pediatric patients with perennial allergic rhinitis. Otolaryngol Head Neck Surg. 2008 Jan;138(1):30-7. doi: 10.1016/j.otohns.2007.10.023.

Reference Type RESULT
PMID: 18164990 (View on PubMed)

Study Documents

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Document Type: Individual Participant Data Set

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: Clinical Study Report

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: 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: 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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FFR30008

Identifier Type: -

Identifier Source: org_study_id

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