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Long Term Safety Of GW685698X Via Nasal Biopsy

NCT ID: NCT00224523

Last Updated: 2016-10-28

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

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2007-02-28

Brief Summary

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Long term safety (52 weeks) of GW685698X on the nasal mucosa via nasal biopsy with an active control group (Nasonex®) and a healthy volunteers control group in subjects 18 years old with perennial allergic rhinitis . Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. Perennial allergic rhinitis is triggered by house dust mites, animal dander, etc., possibly causing symptoms year-round including nasal congestion, rhinorrhea and/or nasal itching.

Detailed Description

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A Randomized, Open Label, Active Controlled (Mometasone Furoate Aqueous Nasal Spray \[Nasonex®\] 200mcg QD), Parallel Group, Multi-Center, 52-Week Study to Assess the Long Term Safety of GW685698X Aqueous Nasal Spray 100mcg QD via Nasal Biopsy in Subjects \>18 Years of Age with Perennial Allergic Rhinitis (PAR)

Conditions

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Rhinitis, Allergic, Perennial

Keywords

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perennial allergic rhinitis nasal biopsy GW685698X

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

GW685698X

Intervention Type DRUG

mometasone furoate

Intervention Type DRUG

Interventions

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GW685698X

Intervention Type DRUG

mometasone furoate

Intervention Type DRUG

Other Intervention Names

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GW685698X

Eligibility Criteria

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Inclusion Criteria

* History of perennial allergic rhinitis of 2 years, with a documented positive allergen test to an appropriate allergen.
* Female patients of child-bearing potential must be willing to consistently and correctly use an acceptable method of birth control.

Exclusion Criteria

* Patients who require certain medications for their allergy.
* Patients with serious medical problems.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

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

Leuven, , Belgium

Site Status

GSK Investigational Site

Amsterdam, , Netherlands

Site Status

GSK Investigational Site

Nijmegen, , Netherlands

Site Status

GSK Investigational Site

The Hague, , Netherlands

Site Status

Countries

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Belgium Netherlands

References

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Fokkens W, Hellings P, Blom H, Jansen A, van Drunen K, Clements D, Wu W, Caldwell M, Philpot E. A comparison of the effects of fluticasone furoate and mometasone furoate nasal sprays on the nasal mucosa. Ann Allergy Asthma Immunol 2008; 100(1) (Supplement 1):A12 (abstract)

Reference Type BACKGROUND

Study Documents

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Document Type: Study Protocol

View Document

Document Type: Dataset Specification

View Document

Document Type: Annotated Case Report Form

View Document

Document Type: Informed Consent Form

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Clinical Study Report

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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FFR104503

Identifier Type: -

Identifier Source: org_study_id