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)
Overview
- Phase
- Phase 3
- Intervention
- GW685698X aqueous nasal spray
- Conditions
- Rhinitis, Allergic, Perennial
- Sponsor
- GlaxoSmithKline
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Arm 1
Intervention: GW685698X aqueous nasal spray
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.