A Study of GW685698X for the Treatment Of Perennial Allergic Rhinitis in Adolescents and Adults
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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.
Condition or disease
Rhinitis, Allergic, Perennial
Drug: GW685698X aqueous nasal spray
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).
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)
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Ages Eligible for Study:
12 Years to 65 Years (Child, Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
Use of tobacco products.
Work a rotating shift.
Significant concurrent medical conditions.
Certain medications such as corticosteroids and allergy medications.
For additional information about this study please refer to the GSK Clinical Study Register
Publications of Results:
Patel D, Ratner P, Clements D, Wu W, Faris M, Philpot E. Lack of effect on hypothalamic-pituitary-adrenal (HPA) axis function by once-daily fluticasone furoate* nasal spray (FFNS) 110 mcg in adolescents and adults with perennial allergic rhinitis (PAR).
Patel P, Ratner P, Clements D, Wu W, Philpot E. Twenty-four hour serum and urine cortisol data support hypothalamic-pituitary adrenocortical axis safety of once-daily fluticasone furoate*nasal spray 110mcg in adolescents and adults with perennial allerg
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):