NCT00224523

Long Term Safety Of GW685698X Via Nasal Biopsy

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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)

Conditions

• Rhinitis, Allergic, Perennial

Interventions

Type	Name	Description
DRUG	GW685698X
DRUG	mometasone furoate

Timeline

• Start date: 2005-09-01
• Primary completion: 2007-02-01
• Completion: 2007-02-01
• First posted: 2005-09-23
• Last updated: 2016-10-28

Locations

4 sites across 2 countries: Belgium, Netherlands