Clinical Trial: A Study of GW685698X for the Treatment Of Perennial Allergic Rhinitis in Adolescents and Adults

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-blind, Parallel Group, Placebo and Active (Prednisone) Controlled, 6-week Study of the Effect of Fluticasone Furoate Aqueous Nasal Spray 100mcg QD on the Hypothalamic Pituitary Ad

Brief Summary: The purpose of this study is to assess the effect of an aqueous nasal spray investigational compound compared to placebo on the hypothalamic pituitary adrenocortical (HPA) axis system in adolescents and adults 12 to 65 years of age with perennial allergic rhinitis. This study can last up to 6 weeks and you will come to the clinic up to 7 times. Clinic visits include physical examinations, vital sign assessments, clinical laboratory assessments, ECGs and allergy skin testing. You will need to complete a daily diary card and spend the night in the clinic on 2 occasions to collect urine and blood samples over 24 hour periods.

Detailed Summary: A randomized, double-blind, parallel group, placebo and active (prednisone) controlled, 6-week study of the effect of GW685698X aqueous nasal spray 100mcg QD on the hypothalamic pituitary adrenocortical (HPA) axis in adolescents and adults 12 to 65 years of age with perennial allergic rhinitis (PAR).
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: Same as current

Current Secondary Outcome: Results of adverse event, laboratory, nasal examination, vital sign, ECG and pharmacokinetic assessments.

Original Secondary Outcome:

  • Adverse events
  • Laboratory results
  • Nasal examination
  • Vital signs
  • ECG assessments
  • Pharmacokinetic assessments


Information By: GlaxoSmithKline

Dates:
Date Received: June 30, 2005
Date Started: January 2005
Date Completion:
Last Updated: September 13, 2016
Last Verified: September 2016