Ignite Creation Date:
2024-05-05 @ 10:39 PM
Last Modification Date:
2024-10-26 @ 10:21 AM
Study NCT ID:
NCT01154153
Status:
COMPLETED
Last Update Posted:
2012-06-26
First Post:
2010-06-22
Brief Title:
Nasacort AQ Hypothalamic-Pituitary-Adrenal HPA Axis Study in Children With Allergic Rhinitis
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Multicenter Randomized Double-blind Placebo-controlled Parallel-group Study Evaluating the Pharmacodynamic Effect of a 6-week Treatment With Triamcinolone Acetonide Aqueous Nasal Spray 110 μg and 220 μg Once Daily on Basal Hypothalamic-Pituitary-Adrenal HPA Axis Function in Children 2 to 12 Years of Age With Allergic Rhinitis AR
Status:
COMPLETED
Status Verified Date:
2012-06
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 primary objective was to evaluate the effect of a 6-week treatment with TAA-AQ 110 μg and TAA-AQ 220 μg once daily QD versus placebo on hypothalamic-pituitary-adrenal HPA axis function as measured by serum cortisol AUC0-24 hr in children 2 to 12 years old with allergic rhinitis AR
Detailed Description:
The study consisted of a run-in single-blind screening phase prerandomization followed by an approximately 6-week double-blind treatment phase postrandomization
Total study duration per participant lasted from 75 to 13 weeks and consisted of
Screening and single-blind phases these 2 phases ran concurrently prerandomization for 8 to 24 days During the screening phase participants were given a single-blind placebo nasal spray to enable them to practice their intranasal application technique once daily in the morning 1 actuationnostril
Randomization to the double-blind treatment phase Treatment assignment was randomized with stratification by sex and age group 2 to 6 6 to 12 years old
Double-blind treatment phase which lasted at least 42 days and ran up to 47 days Participants were administered either TAA-AQ nasal spray or placebo nasal spray
An evaluation at the end of treatment 1-3 days after completion of the double-blind phase
Total study duration per participant lasted from 75 to 13 weeks and consisted of
Screening and single-blind phases these 2 phases ran concurrently prerandomization for 8 to 24 days During the screening phase participants were given a single-blind placebo nasal spray to enable them to practice their intranasal application technique once daily in the morning 1 actuationnostril
Randomization to the double-blind treatment phase Treatment assignment was randomized with stratification by sex and age group 2 to 6 6 to 12 years old
Double-blind treatment phase which lasted at least 42 days and ran up to 47 days Participants were administered either TAA-AQ nasal spray or placebo nasal spray
An evaluation at the end of treatment 1-3 days after completion of the double-blind phase
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