A Study of GW685698X for the Treatment Of Perennial Allergic Rhinitis in Adolescents and Adults - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00116818

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 III

MedlinePlus related topics: Urine and Urination

Drug Information available for: Corticosteroids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety Study
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)

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

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

Publications indexed to this study:

Patel D, Ratner P, Clements D, Wu W, Faris M, Philpot E. Lack of effect on adult and adolescent hypothalamic-pituitary-adrenal axis function with use of fluticasone furoate nasal spray. Ann Allergy Asthma Immunol. 2008 May;100(5):490-6.

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	FFR20002
Study First Received:	June 30, 2005
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00116818
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

perennial allergic rhinitis
intranasal corticosteroid
GW685698X
HPA axis function

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