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. The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with seasonal allergic rhinitis (SAR) caused by ragweed pollen.
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 2 Weeks in Adult and Adolescent Subjects (12 years of age and older) with Seasonal Allergic Rhinitis (SAR)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
288
GSK Investigational Site
Chicago, Illinois, United States
GSK Investigational Site
Indianapolis, Indiana, United States
GSK Investigational Site
Lafayette, Indiana, United States
GSK Investigational Site
Louisville, Kentucky, United States
GSK Investigational Site
Novi, Michigan, United States
GSK Investigational Site
Minneapolis, Minnesota, United States
GSK Investigational Site
Columbia, Missouri, United States
GSK Investigational Site
Rolla, Missouri, United States
GSK Investigational Site
St Louis, Missouri, United States
GSK Investigational Site
Lincoln, Nebraska, United States
...and 8 more locations
Mean change from baseline over the entire treatment period in daily, reflective total nasal symptom scores.
1) Mean change from baseline over the entire treatment period in AM, pre-dose, instantaneous total nasal symptom scores. 2) Mean change from baseline in daily reflective total ocular symptom scores. 3) overall evaluation of response to therapy.
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