A Study Of GW685698X For The Treatment Of Perennial Allergic Rhinitis In Pediatrics

GlaxoSmithKline90 enrolled

Overview

The purpose of this study is to assess the effect of an aqueous nasal spray investigational compound GW685698X compared to placebo on the hypothalamic pituitary adrenocortical (HPA) axis system in children 2 to 11 years of age with perennial allergic rhinitis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Rhinitis, Allergic, Perennial

Interventions

GW685698X aqueous nasal sprayDRUG

Eligibility

Sex: ALLMin age: 2 YearsMax age: 11 Years

Medical Language ↔ Plain English

Inclusion criteria: * Diagnosis and history of perennial allergic rhinitis. * Must be willing to stay overnight in the clinic at the beginning and end of the study for the collection of urine and blood samples over 24 hours. * Must comply with all study procedures and be literate. Exclusion criteria: * Significant concurrent medical conditions. * Certain medications such as corticosteroids and allergy medications.

Locations (12)

GSK Investigational Site

Hot Springs, Arkansas, United States

GSK Investigational Site

Little Rock, Arkansas, United States

GSK Investigational Site

Long Beach, California, United States

Outcomes

Primary Outcomes

HPA axis function at baseline and after 6 weeks of treatment as measured by 24 hour urine and serial serum cortisol assessments in domiciled subjects

Secondary Outcomes

Results of adverse event, laboratory, nasal examination, vital sign, ECG and pharmacokinetic assessments.

Data from ClinicalTrials.gov

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