Clinical Trial: Perennial Allergic Rhinitis Study In Pediatric Subjects
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Two Week Randomized, Double Blind Placebo Controlled, Parallel Group Study of GW685698X Aqueous Nasal Spray 100mcg and 50mcg QD in Pediatric Subjects With Perennial Allergic Rh
Brief Summary: The purpose of this study is to determine if the investigational drug is effective and safe in children with perennial allergic rhinitis.
Detailed Summary: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 50mcg and 100mcg for 12 Weeks in Pediatric Subjects Ages 2 to <12 Years with Perennial Allergic Rhinitis (PAR)
Sponsor: GlaxoSmithKline
Current Primary Outcome: Improvement in daily, reflective total nasal symptom scores after first 4-week treatment period in subjects ages 6 to <12 years.
Original Primary Outcome: Same as current
Current Secondary Outcome: Improvement in AM, pre-dose, instantaneous total nasal symptom scores after first 4-week treatment period, overall evaluation of response to therapy for the first 4-week treatment period for subjects ages 6 to <12 years.
Original Secondary Outcome:
- Improvement in AM, pre-dose, instantaneous total nasal symptom scores after first 4-week treatment period.
- Overall evaluation of response to therapy for the first 4-week treatment period for subjects ages 6 to <12 years.
Information By: GlaxoSmithKline
Dates:
Date Received: April 20, 2005
Date Started: February 2005
Date Completion:
Last Updated: January 18, 2017
Last Verified: January 2017
