Long Term Safety Of GW685698X Via Nasal Biopsy - Full Text View

Purpose

Long term safety (52 weeks) of GW685698X on the nasal mucosa via nasal biopsy with an active control group (Nasonex®) and a healthy volunteers control group in subjects 18 years old with perennial allergic rhinitis . Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. Perennial allergic rhinitis is triggered by house dust mites, animal dander, etc., possibly causing symptoms year-round including nasal congestion, rhinorrhea and/or nasal itching.

Condition	Intervention	Phase
Perennial Allergic Rhinitis	Drug: GW685698X Drug: mometasone furoate	Phase III

ChemIDplus related topics:

Mometasone furoate Salicylsalicylic acid Sodium salicylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study

Official Title:	A Randomized, Open Label, Active Controlled (Mometasone Furoate Aqueous Nasal Spray [Nasonex®] 200mcg QD), Parallel Group, Multi-Center, 52-Week Study to Assess the Long Term Safety of GW685698X Aqueous Nasal Spray 100mcg QD Via Nasal Biopsy in Subjects >18 Years of Age With Perennial Allergic Rhinitis (PAR)

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Quantitative and qualitative differences in the morphology and cytology of the nasal mucosa after 1 year of treatment.

Secondary Outcome Measures:

No Secondary Outcome Measures

Estimated Enrollment:	125
Study Start Date:	September 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria:

History of perennial allergic rhinitis of 2 years, with a documented positive allergen test to an appropriate allergen.
Female patients of child-bearing potential must be willing to consistently and correctly use an acceptable method of birth control.

Exclusion criteria:

Patients who require certain medications for their allergy.
Patients with serious medical problems.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00224523

Locations


Belgium
	GSK Clinical Trials Call Center
	Leuven, Belgium, 3000

Netherlands
	GSK Clinical Trials Call Center
	Nijmegen, Netherlands, 6525EX
	GSK Clinical Trials Call Center
	Amsterdam, Netherlands, 1105AZ
	GSK Clinical Trials Call Center
	Den Haag, Netherlands, 2566MJ

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials, MD	GlaxoSmithKline

More Information

Study ID Numbers:	FFR104503
First Received:	August 26, 2005
Last Updated:	August 22, 2007
ClinicalTrials.gov Identifier:	NCT00224523
Health Authority:	Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Keywords provided by GlaxoSmithKline:

GW685698X

perennial allergic rhinitis

nasal biopsy

Study placed in the following topic categories:

Hypersensitivity

Otorhinolaryngologic Diseases

Respiratory Tract Infections

Respiratory Tract Diseases

Rhinitis, Allergic, Perennial

Mometasone furoate

Salicylsalicylic acid

Sodium Salicylate

Hypersensitivity, Immediate

Rhinitis

Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Immune System Diseases

Therapeutic Uses

Anti-Allergic Agents

Pharmacologic Actions

Nose Diseases

ClinicalTrials.gov processed this record on August 28, 2008

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00224523