Study of GW685698X In Patients With Seasonal Allergic Rhinitis

GlaxoSmithKline38 enrolled

Overview

This study was designed to compare the efficacy and safety of an investigational nasal spray compared with placebo nasal spray and commonly used drug 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. Typical symptoms are sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Rhinitis, Allergic, Seasonal

Interventions

GW685698X Aqueous Nasal SprayDRUG

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

Inclusion criteria: * Informed consent * Outpatient * Diagnosis of seasonal allergic rhinitis with symptoms * Able to comply with study procedures Exclusion Criteria: * Significant concomitant medical condition * Use of corticosteroids/allergy medications * Laboratory abnormality * Positive pregnancy test * Allergy to any component of investigational product

Locations (1)

GSK Investigational Site

Outcomes

Primary Outcomes

Mean change from baseline over the entire treatment period in three total nasal symptom scores.

Secondary Outcomes

Mean change from baseline over the entire treatment period in four total nasal symptom scores.

Mean change from baseline over the entire treatment period in individual total nasal symptom scores.

Data from ClinicalTrials.gov

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