Study In Adolescent And Adult Subjects 12 Years Of Age And Older With Seasonal Allergic Rhinitis To Assess Onset of Action

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

380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2005-08-31

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 purpose of this study is to evaluate the onset of action of an investigational nasal spray, GW685698X aqueous nasal spray, versus vehicle placebo nasal spray in the treatment of seasonal allergic rhinitis caused by ragweed following a single dose of treatment in controlled pollen concentrations in an allergen challenge chamber.

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Detailed Description

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Randomized, Double Blind, Placebo-Controlled, Single-Dose, Parallel-Group Study to Evaluate the Onset of Action of a Single Dose of Intranasal GW685698X Aqueous Nasal Spray 100 mcg in Adolescent and Adult Subjects (=12 years of age) With Seasonal Allergic Rhinitis Exposed to Ragweed Pollen in an Allergen Challenge Chamber

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

Participants Investigators

Study Groups

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Arm 1

Group Type EXPERIMENTAL

GW685698X Aqueous Nasal Spray

Intervention Type DRUG

Interventions

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GW685698X Aqueous Nasal Spray

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Informed consent
* Outpatient
* Females must use appropriate contraception
* Diagnosis of seasonal allergic rhinitis
* Able to comply with study procedures
* Literate

Exclusion Criteria

* Significant concomitant medical condition
* Use of corticosteroids, allergy medications, or tobacco
* Clinically significant abnormal ECG
* Laboratory abnormality
* Positive pregnancy test
* Allergy to any component of investigational product

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

Woodstock, Georgia, United States

Site Status

Countries

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United States

Study Documents

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