Long Term Safety Of GW685698X Via Nasal Biopsy - Tabular View

Tracking Information

First Received Date ^ICMJE

August 26, 2005

Last Updated Date

October 13, 2008

Start Date ^ICMJE

September 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00224523 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

No Secondary Outcome Measures

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Long Term Safety Of GW685698X Via Nasal Biopsy

Official Title ^ICMJE

See Detailed Description

Brief Summary

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.

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)

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Parallel Assignment, Safety Study

Condition ^ICMJE

Perennial Allergic Rhinitis

Intervention ^ICMJE

Drug: GW685698X
Drug: mometasone furoate

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

125

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium, Netherlands

Administrative Information

NCT ID ^ICMJE

NCT00224523

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

FFR104503

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP