A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 14 Days in Adult and Adolescent Subjects With Seasonal Allergic Rhinitis
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Hayfever
- Sponsor
- GlaxoSmithKline
- Enrollment
- 304
- Locations
- 1
- Primary Endpoint
- Mean change from baseline over the entire treatment period in daily, reflective, total nasal symptom scores.
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of the study is to compare the efficacy and safety of an investigational nasal spray compared with placebo nasal spray in the treatment of seasonal allergic rhinitis. Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. The focus of this study, seasonal allergic rhinitis (SAR), is one type of allergic rhinitis that is triggered by the pollen from trees, grasses, and weeds. Commonly referred to as "hay fever", it is characterized by sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Mean change from baseline over the entire treatment period in daily, reflective, total nasal symptom scores.
Mean change from baseline over the entire treatment period in the daily, reflective, total ocular symptom score.
Secondary Outcomes
- Mean change from baseline over the entire treatment period in AM, pre-dose, instantaneous, total nasal symptom score.