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

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00118729

Purpose

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.

Condition	Intervention	Phase
Seasonal Allergic Rhinitis	Drug: GW685698X Aqueous Nasal Spray	Phase III

MedlinePlus related topics: Hay Fever

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Mean change from baseline in subject-rated total nasal symptom score following a single dose of GW685698X aqueous nasal spray during exposure to ragweed pollen over a 12-hour period.

Secondary Outcome Measures:

Change from baseline in the individual nasal symptom scores of rhinorrhea, nasal congestion, nasal itching and sneezing, assessed hourly during the 12-hour, post-dose exposure period to ragweed pollen in the allergen challenge chamber.

Estimated Enrollment:	380
Study Start Date:	April 2005
Study Completion Date:	August 2005
Primary Completion Date:	August 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00118729

Locations

United States, Georgia
GSK Clinical Trials Call Center
Atlanta, Georgia, United States, 30188

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Study ID Numbers:	FFR101816
Study First Received:	July 1, 2005
Last Updated:	June 9, 2008
ClinicalTrials.gov Identifier:	NCT00118729
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

seasonal allergic rhinitis
onset
GW685698X
Ragweed

Study placed in the following topic categories:

Hypersensitivity
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

Rhinitis, Allergic, Seasonal
Hypersensitivity, Immediate
Rhinitis
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Immune System Diseases
Nose Diseases

ClinicalTrials.gov processed this record on January 16, 2009