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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00116883
First received: June 30, 2005
Last updated: October 1, 2010
Last verified: October 2010
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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).

Resource links provided by NLM:


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
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: GW685698X aqueous nasal spray
    Other Name: GW685698X aqueous nasal spray
  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
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: NCT00116883

Locations
United States, Arkansas
GSK Investigational Site
Hot Springs, Arkansas, United States, 71913
GSK Investigational Site
Little Rock, Arkansas, United States, 72202
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
Orangeburg, South Carolina, United States, 29118
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
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

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00116883     History of Changes
Other Study ID Numbers: FFR100012
Study First Received: June 30, 2005
Last Updated: October 1, 2010
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 24, 2014