A Study of GW685698X for the Treatment Of Perennial Allergic Rhinitis in Adolescents and Adults

Study Overview
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Brief Summary
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The purpose of this study is to assess the effect of an aqueous nasal spray investigational compound compared to placebo on the hypothalamic pituitary adrenocortical (HPA) axis system in adolescents and adults 12 to 65 years of age with perennial allergic rhinitis. This study can last up to 6 weeks and you will come to the clinic up to 7 times. Clinic visits include physical examinations, vital sign assessments, clinical laboratory assessments, ECGs and allergy skin testing. You will need to complete a daily diary card and spend the night in the clinic on 2 occasions to collect urine and blood samples over 24 hour periods.

Detailed Description
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A randomized, double-blind, parallel group, placebo and active (prednisone) controlled, 6-week study of the effect of GW685698X aqueous nasal spray 100mcg QD on the hypothalamic pituitary adrenocortical (HPA) axis in adolescents and adults 12 to 65 years of age with perennial allergic rhinitis (PAR).

Official Title
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A Randomized, Double-blind, Parallel Group, Placebo and Active (Prednisone) Controlled, 6-week Study of the Effect of Fluticasone Furoate Aqueous Nasal Spray 100mcg QD on the Hypothalamic Pituitary Adrenocortical (HPA) Axis in Adolescents and Adults 12 to 65 Years of Age With Perennial Allergic Rhinitis (PAR)

Conditions
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Rhinitis, Allergic, Perennial

Intervention / Treatment
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* Drug: GW685698X aqueous nasal spray


Participation Criteria
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Eligibility Criteria
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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: Use of tobacco products. Work a rotating shift. Significant concurrent medical conditions. Certain medications such as corticosteroids and allergy medications.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: GW685698X aqueous nasal spray<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Results of adverse event, laboratory, nasal examination, vital sign, ECG and pharmacokinetic assessments. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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perennial allergic rhinitis, intranasal corticosteroid, HPA axis function, GW685698X