Back to resultsA Study Of GW685698X For The Treatment Of Perennial Allergic Rhinitis In Pediatrics
Primary Purpose
Rhinitis, Allergic, Perennial
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
GW685698X aqueous nasal spray
Sponsored by
About this trial
This is an interventional treatment trial for Rhinitis, Allergic, Perennial focused on measuring GW685698X, perennial allergic rhinitis, pediatric, intranasal corticosteroid, HPA axis function
Eligibility 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.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1
Arm Description
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00116883
Brief Title
A Study Of GW685698X For The Treatment Of Perennial Allergic Rhinitis In Pediatrics
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).
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Allergic, Perennial
Keywords
GW685698X, perennial allergic rhinitis, pediatric, intranasal corticosteroid, HPA axis function
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
GW685698X aqueous nasal spray
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Results of adverse event, laboratory, nasal examination, vital sign, ECG and pharmacokinetic assessments.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
GSK Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
GSK Investigational Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
GSK Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
GSK Investigational Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
GSK Investigational Site
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70503
Country
United States
Facility Name
GSK Investigational Site
City
Rolla
State/Province
Missouri
ZIP/Postal Code
65401
Country
United States
Facility Name
GSK Investigational Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
GSK Investigational Site
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
GSK Investigational Site
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
GSK Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
GSK Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
FFR100012
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
FFR100012
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
FFR100012
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
FFR100012
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
FFR100012
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
FFR100012
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
FFR100012
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
A Study Of GW685698X For The Treatment Of Perennial Allergic Rhinitis In Pediatrics
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