A Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Multicentre Two Week Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg in Adult and Adolescent Subjects With Seasonal Allergic Rhinitis in Europe

GlaxoSmithKline1 site in 1 country288 target enrollmentMay 2005

ConditionsRhinitis, Allergic, Seasonal

DrugsGW685698X

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Rhinitis, Allergic, Seasonal
Sponsor: GlaxoSmithKline
Enrollment: 288
Locations: 1
Primary Endpoint: Mean change from baseline over the entire treatment period in daily, reflective, total nasal symptom scores (rTNSS).
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

May 2005

End Date

August 2005

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

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 (rTNSS).

Secondary Outcomes

Mean change from baseline over the entire tx period in AM, pre-dose iTNS. Mean change from baseline over the entire treatment period in rTOSS. Overall evaluation of response to therapy.