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| 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 |
| Estimated Enrollment: | 125 |
| Study Start Date: | September 2005 |
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 |
Inclusion criteria:
Exclusion criteria:
Contacts and 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 | |
| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| 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 |
|
GW685698X perennial allergic rhinitis nasal biopsy |
|
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 |
|
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 |