Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00116818
Status:
COMPLETED
Last Update Posted:
2016-09-15
First Post:
2005-06-30
Brief Title:
A Study of GW685698X for the Treatment Of Perennial Allergic Rhinitis in Adolescents and Adults
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None