Study In Adults And Adolescents With Seasonal Allergic Rhinitis - Full Text View

Purpose

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.

Condition	Intervention	Phase
Hayfever Allergic Rhinitis Seasonal Rhinitis	Drug: GW685698X	Phase III

MedlinePlus related topics:

Hay Fever

ChemIDplus related topics:

Corticosteroids 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:	A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Two Week Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100 Mcg in Adult and Adolescent Subjects With Seasonal Allergic Rhinitis in Europe

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Mean change from baseline over the entire treatment period in daily, reflective, total nasal symptom scores (rTNSS).

Secondary Outcome Measures:

Mean change from baseline over the entire tx period in AM, pre-dose iTNS. Mean change from baseline over the entire treatment period in rTOSS. Overall evaluation of response to therapy.

Estimated Enrollment:	288
Study Start Date:	May 2005

Eligibility

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

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00225823

Locations


Estonia
	GSK Clinical Trials Call Center
	Tartu, Estonia, 51014
	GSK Clinical Trials Call Center
	Tallinn, Estonia, 13419

Latvia
	GSK Clinical Trials Call Center
	Riga, Latvia, LV 1004
	GSK Clinical Trials Call Center
	Riga, Latvia, LV 1002
	GSK Clinical Trials Call Center
	Liepaja, Latvia, LV 3401
	GSK Clinical Trials Call Center
	Riga, Latvia, LV 1001
	GSK Clinical Trials Call Center
	Riga, Latvia, LV 1003

Lithuania
	GSK Clinical Trials Call Center
	Vilnius, Lithuania, LT-10200
	GSK Clinical Trials Call Center
	Vilnius, Lithuania, LT-09125
	GSK Clinical Trials Call Center
	Vilnius, Lithuania, LT-08661
	GSK Clinical Trials Call Center
	Kaunas, Lithuania, LT-50009
	GSK Clinical Trials Call Center
	Kaunas, Lithuania, 50425

Netherlands
	GSK Clinical Trials Call Center
	Leeuwarden, Netherlands, 8934 AD
	GSK Clinical Trials Call Center
	Amsterdam, Netherlands, 1105 AZ
	GSK Clinical Trials Call Center
	Tilburg, Netherlands, 5038 NM
	GSK Clinical Trials Call Center
	Arnhem, Netherlands, 6824 BJ
	GSK Clinical Trials Call Center
	Haarlem, Netherlands, 2035 RC
	GSK Clinical Trials Call Center
	Assen, Netherlands, 9401 RK
	GSK Clinical Trials Call Center
	Schiedam, Netherlands, 3116 BA

Russian Federation
	GSK Clinical Trials Call Center
	Volgograd, Russian Federation, 400130
	GSK Clinical Trials Call Center
	Saint-Petersburg, Russian Federation, 190013
	GSK Clinical Trials Call Center
	Moscow, Russian Federation, 115446

Sweden
	GSK Clinical Trials Call Center
	Angelhom, Sweden, SE-262 81
	GSK Clinical Trials Call Center
	Vasteras, Sweden, SE-721 89
	GSK Clinical Trials Call Center
	Malmo, Sweden, SE-211 36
	GSK Clinical Trials Call Center
	Lund, Sweden, SE-221 85

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials, MD	GlaxoSmithKline

More Information

Study ID Numbers:	FFR103184
First Received:	September 22, 2005
Last Updated:	June 9, 2008
ClinicalTrials.gov Identifier:	NCT00225823
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Seasonal Allergic Rhinitis Intranasal Corticosteroid

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

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:	NCT00225823