A Study Of GW685698X For The Treatment Of Perennial Allergic Rhinitis In Pediatrics - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00116883

Purpose

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.

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

MedlinePlus related topics: Children's Health

Drug Information available for: Corticosteroids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety Study
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 Children 2 to 11 Years of Age With Perennial Allergic Rhinitis (PAR).

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:	February 2005

Eligibility

Ages Eligible for Study:	2 Years to 11 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:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00116883

Locations

United States, Arkansas
GSK Investigational Site
Little Rock, Arkansas, United States, 72202
GSK Investigational Site
Hot Springs, Arkansas, United States, 71913
United States, California
GSK Investigational Site
Long Beach, California, United States, 90806
United States, Florida
GSK Investigational Site
Jacksonville, Florida, United States, 32207
United States, Louisiana
GSK Investigational Site
Lafayette, Louisiana, United States, 70503
United States, Missouri
GSK Investigational Site
Rolla, Missouri, United States, 65401
United States, Oregon
GSK Investigational Site
Medford, Oregon, United States, 97504
United States, South Carolina
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118
United States, Texas
GSK Investigational Site
San Antonio, Texas, United States, 78229
United States, Virginia
GSK Investigational Site
Richmond, Virginia, United States, 23298

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	FFR100012
Study First Received:	June 30, 2005
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00116883
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

perennial allergic rhinitis
intranasal corticosteroid
GW685698X
HPA axis function
pediatric

Study placed in the following topic categories:

Hypersensitivity
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

Rhinitis, Allergic, Perennial
Hypersensitivity, Immediate
Rhinitis
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Immune System Diseases
Nose Diseases

ClinicalTrials.gov processed this record on January 14, 2009