Study In Adults And Adolescents With Seasonal Allergic Rhinitis.

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

2005-05-31

Study Completion Date

2005-08-31

Brief Summary

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Compare the efficacy and safety of an investigational nasal spray compared with placebo nasal spray in the treatment of seasonal allergic rhinitis. 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.

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Detailed Description

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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

Interventions

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GW685698X

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Informed consent.
* Must be an outpatient.
* Females must be using appropriate contraception.
* Must have diagnosis of seasonal allergic rhinitis, adequate exposure to allergen.
* Must be able to comply with study procedures.
* Must be literate.

Exclusion Criteria

* A significant concomitant medical condition.
* Use of corticosteroids or allergy or medications or tobacco.
* Clinically significant abnormal ECG.
* Laboratory abnormality.
* Positive pregnancy test.
* Allergy to any component of the 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

Tallinn, , Estonia

Site Status

GSK Investigational Site

Tartu, , Estonia

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GSK Investigational Site

Liepāja, , Latvia

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GSK Investigational Site

Riga, , Latvia

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GSK Investigational Site

Riga, , Latvia

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GSK Investigational Site

Riga, , Latvia

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GSK Investigational Site

Riga, , Latvia

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GSK Investigational Site

Kaunas, , Lithuania

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GSK Investigational Site

Kaunas, , Lithuania

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GSK Investigational Site

Šiauliai, , Lithuania

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GSK Investigational Site

Vilnius, , Lithuania

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GSK Investigational Site

Amsterdam, , Netherlands

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GSK Investigational Site

Arnhem, , Netherlands

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GSK Investigational Site

Assen, , Netherlands

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GSK Investigational Site

Leeuwarden, , Netherlands

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GSK Investigational Site

Schiedam, , Netherlands

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GSK Investigational Site

Tilburg, , Netherlands

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GSK Investigational Site

Moscow, , Russia

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GSK Investigational Site

Saint Petersburg, , Russia

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GSK Investigational Site

Volgograd, , Russia

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GSK Investigational Site

Ängelholm, , Sweden

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GSK Investigational Site

Lund, , Sweden

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GSK Investigational Site

Malmo, , Sweden

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GSK Investigational Site

Västerås, , Sweden

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Countries

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Estonia Latvia Lithuania Netherlands Russia Sweden

Study Documents

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