Clinical Trial: A Study Of GW685698X For The Treatment Of Perennial Allergic Rhinitis In Pediatrics
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Double-blind, Parallel Group, Placebo Controlled, 6-week Study of the Effect of GW685698X Aqueous Nasal Spray 100mcg QD on the Hypothalamic Pituitary Adrenocortical (HPA) Axis in Childre
Brief Summary: The purpose of this study is to assess the effect of an aqueous nasal spray investigational compound GW685698X compared to placebo on the hypothalamic pituitary adrenocortical (HPA) axis system in children 2 to 11 years of age with perennial allergic rhinitis.
Detailed Summary:
Sponsor: GlaxoSmithKline
Current Primary Outcome: 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
Original Primary Outcome: 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.
Current Secondary Outcome: Results of adverse event, laboratory, nasal examination, vital sign, ECG and pharmacokinetic assessments.
Original Secondary Outcome:
- Adverse events
- Laboratory values
- Nasal examination
- Vital signs
- ECG assessments
- Pharmacokinetic assessments
Information By: GlaxoSmithKline
Dates:
Date Received: June 30, 2005
Date Started: February 2005
Date Completion:
Last Updated: September 13, 2016
Last Verified: September 2016
