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

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

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety Study
Official Title:	See Detailed Description

Resource links provided by NLM:

Drug Information available for: Mometasone furoate GW 685698X GW 685698

U.S. FDA Resources

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

Detailed Description:

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)

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 Investigational Site
Leuven, Belgium, 3000
Netherlands
GSK Investigational Site
DEN HAAG, Netherlands, 2566 MJ
GSK Investigational Site
AMSTERDAM, Netherlands, 1105 AZ
GSK Investigational Site
NIJMEGEN, Netherlands, 6525 EX

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	FFR104503
Study First Received:	August 26, 2005
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00224523 History of Changes
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:

Anti-Inflammatory Agents
Hypersensitivity
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Rhinitis, Allergic, Perennial

Mometasone furoate
Hypersensitivity, Immediate
Rhinitis
Anti-Allergic Agents
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Otorhinolaryngologic Diseases
Immune System Diseases
Mometasone furoate
Rhinitis
Anti-Allergic Agents
Pharmacologic Actions
Nose Diseases

Hypersensitivity
Rhinitis, Allergic, Perennial
Respiratory Tract Diseases
Respiratory Tract Infections
Therapeutic Uses
Hypersensitivity, Immediate
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on July 02, 2009