Once-Daily Investigational Nasal Spray In Adults And Adolescents With Seasonal Allergic Rhinitis (SAR)

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

2005-08-31

Study Completion Date

2005-10-31

Brief Summary

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Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. The focus of this study, seasonal allergic rhinitis (SAR), is one type of allergic rhinitis that is triggered by the pollen from trees, grasses, and weeds. Commonly referred to as (hay fever), it is characterized by sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes. 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 seasonal allergic rhinitis (SAR) caused by ragweed pollen.

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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 2 Weeks in Adult and Adolescent Subjects (12 years of age and older) with Seasonal Allergic Rhinitis (SAR)

Conditions

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Rhinitis, Allergic, Seasonal

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 Aqueous Nasal Spray

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Must be outpatients.
* Diagnosis of SAR.
* Literate in English or native language.

Exclusion Criteria

* Have a significant concomitant medical condition.
* Use corticosteroids or other allergy medications during the study.
* Use tobacco products.

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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

Chicago, Illinois, United States

Site Status

GSK Investigational Site

Indianapolis, Indiana, United States

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GSK Investigational Site

Lafayette, Indiana, United States

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GSK Investigational Site

Louisville, Kentucky, United States

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GSK Investigational Site

Novi, Michigan, United States

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GSK Investigational Site

Minneapolis, Minnesota, United States

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GSK Investigational Site

Columbia, Missouri, United States

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GSK Investigational Site

Rolla, Missouri, United States

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GSK Investigational Site

St Louis, Missouri, United States

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GSK Investigational Site

Lincoln, Nebraska, United States

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GSK Investigational Site

Papillion, Nebraska, United States

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GSK Investigational Site

Canton, Ohio, United States

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GSK Investigational Site

Sylvania, Ohio, United States

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GSK Investigational Site

Spartanburg, South Carolina, United States

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GSK Investigational Site

Dallas, Texas, United States

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GSK Investigational Site

Dallas, Texas, United States

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GSK Investigational Site

Greenfield, Wisconsin, United States

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GSK Investigational Site

West Allis, Wisconsin, United States

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Countries

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United States

Study Documents

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