Clinical Trial: An Efficacy and Safety Evaluation of Nasacort AQ in Children Ages 2-5 Years With Perennial Allergic Rhinitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Efficacy and Safety Evaluation of Nasacort AQ 110 µg QD Children Ages 2-5 Years With Perennial Allergic Rhinitis
Brief Summary:
The purposes of this study are:
- To demonstrate the efficacy of once daily administration of Nasacort AQ 110 µg compared with placebo in children 2-5 years of age with perennial allergic rhinitis; and
- To assess the safety of Nasacort AQ 110 µg in children 2-5 years of age.
Detailed Summary:
Sponsor: Sanofi
Current Primary Outcome:
- Double-blind phase: Change from baseline in mean daily instantaneous (immediately prior to dosing) Total Nasal Symptom Score (TNSS) over the 4-week double-blind period
- Open-label phase: The efficacy variable is the global evaluation of efficacy as rated by the physician and the subject
Original Primary Outcome:
Current Secondary Outcome:
- Change from baseline: in mean daily reflective (previous 24 hours) TNSS over 4-wk double-blind period
- for mean daily instantaneous and reflective TNSS by week
- for mean instantaneous and reflective daily scores for nasal stuffiness, nasal discharge, sneezing, nasal itching, and total eye symptoms by week and over four week double-blind period
Original Secondary Outcome:
Information By: Sanofi
Dates:
Date Received: August 18, 2005
Date Started: November 2003
Date Completion: February 2006
Last Updated: January 10, 2011
Last Verified: January 2011
