Long Term Safety Of GW685698X Via Nasal Biopsy
- Conditions
- Rhinitis, Allergic, Perennial
- Interventions
- Drug: GW685698XDrug: mometasone furoate
- Registration Number
- NCT00224523
- Lead Sponsor
- GlaxoSmithKline
- 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 125
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 GW685698X - Arm 1 mometasone furoate -
- Primary Outcome Measures
Name Time Method Quantitative and qualitative differences in the morphology and cytology of the nasal mucosa after 1 year of treatment.
- Secondary Outcome Measures
Name Time Method No Secondary Outcome Measures
Trial Locations
- Locations (1)
GSK Investigational Site
🇳🇱Nijmegen, Netherlands