Clinical Trial: Once-Daily Investigational Nasal Spray In Adults And Adolescents With Seasonal Allergic Rhinitis (SAR)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Single-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100 mcg for 2 Weeks

Brief Summary: 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.

Detailed Summary: 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)
Sponsor: GlaxoSmithKline

Current Primary Outcome: Mean change from baseline over the entire treatment period in daily, reflective total nasal symptom scores.

Original Primary Outcome: Same as current

Current Secondary Outcome: 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.

Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: September 15, 2005
Date Started: August 2005
Date Completion:
Last Updated: January 18, 2017
Last Verified: January 2017