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

Rhinitis, Allergic, Perennial Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00116883
• Other study ID #: FFR100012
• Status: Completed
• Phase: Phase 3
• First received: June 30, 2005
• Last updated: September 13, 2016
• Start date: February 2005
• Est. completion date: July 2005

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 2005
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 11 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Perennial

Intervention

Drug:
• GW685698X aqueous nasal spray

Locations

Country	Name	City	State
United States	GSK Investigational Site	Hot Springs	Arkansas
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Lafayette	Louisiana
United States	GSK Investigational Site	Little Rock	Arkansas
United States	GSK Investigational Site	Long Beach	California
United States	GSK Investigational Site	Medford	Oregon
United States	GSK Investigational Site	Orangeburg	South Carolina
United States	GSK Investigational Site	Richmond	Virginia
United States	GSK Investigational Site	Rolla	Missouri
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	Spartanburg	South Carolina
United States	GSK Investigational Site	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Results of adverse event, laboratory, nasal examination, vital sign, ECG and pharmacokinetic assessments.

External Links

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