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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00116818
First received: June 30, 2005
Last updated: October 13, 2008
Last verified: October 2008
  Purpose

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.


Condition Intervention Phase
Perennial Allergic Rhinitis
Drug: GW685698X aqueous nasal spray
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: See Detailed Description

Further study details as provided by GlaxoSmithKline:

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

Estimated Enrollment: 90
Study Start Date: January 2005
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: GW685698X aqueous nasal spray
    Other Name: GW685698X aqueous nasal spray
Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  • Use of tobacco products.
  • Work a rotating shift.
  • Significant concurrent medical conditions.
  • Certain medications such as corticosteroids and allergy medications.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00116818

Locations
United States, Texas
GSK Investigational Site
San Antonio, Texas, United States, 78229
Canada, Ontario
GSK Investigational Site
Mississauga, Ontario, Canada, L4W 1N2
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD, MBA GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00116818     History of Changes
Other Study ID Numbers: FFR20002
Study First Received: June 30, 2005
Last Updated: October 13, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
perennial allergic rhinitis
intranasal corticosteroid
GW685698X
HPA axis function

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on October 19, 2014