A Study Of GW685698X For The Treatment Of Perennial Allergic Rhinitis In Pediatrics

Overview

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.

Full Title of Study: “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 Children 2 to 11 Years of Age With Perennial Allergic Rhinitis (PAR).”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Double (Participant, Investigator)
• Study Primary Completion Date: July 2005

Interventions

• Drug: GW685698X aqueous nasal spray

Arms, Groups and Cohorts

• Experimental: Arm 1

Clinical Trial Outcome Measures

Primary Measures

• 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

Secondary Measures

• Results of adverse event, laboratory, nasal examination, vital sign, ECG and pharmacokinetic assessments.

Participating in This Clinical Trial

Inclusion Criteria

• Diagnosis and history of perennial allergic rhinitis. – Must be willing to stay overnight in the clinic at the beginning and end of the study for the collection of urine and blood samples over 24 hours. – Must comply with all study procedures and be literate. Exclusion criteria:

• Significant concurrent medical conditions. – Certain medications such as corticosteroids and allergy medications.

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: 11 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • GlaxoSmithKline
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • GSK Clinical Trials, Study Director, GlaxoSmithKline