Study In Adults And Adolescents With Seasonal Allergic Rhinitis.

GlaxoSmithKline288 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

288

Conditions

Rhinitis, Allergic, Seasonal

Interventions

GW685698XDRUG

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

Inclusion criteria: * Informed consent. * Must be an outpatient. * Females must be using appropriate contraception. * Must have diagnosis of seasonal allergic rhinitis, adequate exposure to allergen. * Must be able to comply with study procedures. * Must be literate. Exclusion criteria: * A significant concomitant medical condition. * Use of corticosteroids or allergy or medications or tobacco. * Clinically significant abnormal ECG. * Laboratory abnormality. * Positive pregnancy test. * Allergy to any component of the investigational product.

Locations (24)

GSK Investigational Site

Tallinn, Estonia

GSK Investigational Site

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.

Data from ClinicalTrials.gov

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