NCT00197262

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

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 in Adult and Adolescent Subjects With Seasonal Allergic Rhinitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 288 (planned)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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 description

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)

Conditions

• Rhinitis, Allergic, Seasonal

Interventions

Type	Name	Description
DRUG	GW685698X Aqueous Nasal Spray

Timeline

• Start date: 2005-08-01
• Primary completion: 2005-10-01
• Completion: 2005-10-01
• First posted: 2005-09-20
• Last updated: 2017-01-19

Locations

18 sites across 1 country: United States