Study of GW685698X In Patients With Seasonal Allergic Rhinitis - Full Text View

Purpose

This study was designed to compare the efficacy and safety of an investigational nasal spray compared with placebo nasal spray and commonly used drug 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. Typical symptoms are sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes.

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

MedlinePlus related topics:

Hay Fever

ChemIDplus related topics:

Fluticasone propionate Fluticasone Salicylsalicylic acid Sodium salicylate

U.S. FDA Resources

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

Official Title:	Clinical Evaluation of GW685698 for Seasonal Allergic Rhinitis -A Placebo-Controlled Study to Determine the Non-Inferiority of GW685698 Over Fluticasone Propionate Using a Double-Blind Manner-

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Mean change from baseline over the entire treatment period in three total nasal symptom scores.

Secondary Outcome Measures:

Mean change from baseline over the entire treatment period in four total nasal symptom scores.
Mean change from baseline over the entire treatment period in individual total nasal symptom scores.

Estimated Enrollment:	38
Study Start Date:	January 2005

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Informed consent
Outpatient
Diagnosis of seasonal allergic rhinitis with symptoms
Able to comply with study procedures

Exclusion Criteria:

Significant concomitant medical condition
Use of corticosteroids/allergy medications
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: NCT00363740

Locations


Japan
	GSK Clinical Trials Call Center
	Shiki, Japan, 353
	GSK Clinical Trials Call Center
	Tokyo, Japan, 160
	GSK Clinical Trials Call Center
	Tokyo, Japan, 103
	GSK Clinical Trials Call Center
	Saitama, Japan, 336
	GSK Clinical Trials Call Center
	Tokyo, Japan, 131

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials, MD	GlaxoSmithKline

More Information

Study ID Numbers:	FFR100652
First Received:	August 11, 2006
Last Updated:	August 11, 2006
ClinicalTrials.gov Identifier:	NCT00363740
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:

Seasonal Allergic Rhinitis

allergic rhinitis

GW685698X

Study placed in the following topic categories:

Hypersensitivity

Otorhinolaryngologic Diseases

Respiratory Tract Infections

Respiratory Tract Diseases

Rhinitis, Allergic, Seasonal

Salicylsalicylic acid

Sodium Salicylate

Hypersensitivity, Immediate

Fluticasone

Rhinitis

Respiratory Hypersensitivity

Additional relevant MeSH terms:

Immune System Diseases

Nose Diseases

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00363740