Seasonal Allergic Rhinitis In Pediatric Subjects

September 13, 2016 updated by: GlaxoSmithKline

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 50mcg and 100mcg for 2 Weeks in Pediatric Subjects Ages 2 to <12 Years With Seasonal Allergic Rhinitis (SAR)

The purpose of this study is to determine if the investigational drug is effective and safe in children with seasonal allergic rhinitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

576

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • GSK Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • GSK Investigational Site
    • California
      • Costa Mesa, California, United States, 92626
        • GSK Investigational Site
      • Cudahy, California, United States, 90201
        • GSK Investigational Site
      • Huntington Beach, California, United States, 92647
        • GSK Investigational Site
      • Long Beach, California, United States, 90808
        • GSK Investigational Site
      • Long Beach, California, United States, 90806
        • GSK Investigational Site
      • Mission Viejo, California, United States, 92691
        • GSK Investigational Site
      • Orange, California, United States, 92868
        • GSK Investigational Site
      • Riverside, California, United States, 92506
        • GSK Investigational Site
      • San Diego, California, United States, 92123
        • GSK Investigational Site
      • Walnut Creek, California, United States, 94598
        • GSK Investigational Site
    • Colorado
      • Centennial, Colorado, United States, 80112
        • GSK Investigational Site
      • Denver, Colorado, United States, 80206
        • GSK Investigational Site
      • Denver, Colorado, United States, 80230
        • GSK Investigational Site
      • Englewood, Colorado, United States, 80112
        • GSK Investigational Site
      • Fort Collins, Colorado, United States, 80526
        • GSK Investigational Site
      • Lakewood, Colorado, United States, 80401
        • GSK Investigational Site
    • Florida
      • Miami, Florida, United States, 33176
        • GSK Investigational Site
      • Tampa, Florida, United States, 33613
        • GSK Investigational Site
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • GSK Investigational Site
      • Lawrenceville, Georgia, United States, 30045
        • GSK Investigational Site
      • Lilburn, Georgia, United States, 30047
        • GSK Investigational Site
      • Stockbridge, Georgia, United States, 30281
        • GSK Investigational Site
      • Woodstock, Georgia, United States, 30188
        • GSK Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46208
        • GSK Investigational Site
    • Kansas
      • Topeka, Kansas, United States, 66606
        • GSK Investigational Site
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • GSK Investigational Site
      • Shreveport, Louisiana, United States, 71105
        • GSK Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21236
        • GSK Investigational Site
      • Bethesda, Maryland, United States, 20814
        • GSK Investigational Site
    • Massachusetts
      • Brockton, Massachusetts, United States, 02301
        • GSK Investigational Site
      • North Andover, Massachusetts, United States, 01845
        • GSK Investigational Site
      • North Dartmouth, Massachusetts, United States, 02747
        • GSK Investigational Site
      • Springfield, Massachusetts, United States, 01107
        • GSK Investigational Site
    • Michigan
      • Richland, Michigan, United States, 49083
        • GSK Investigational Site
      • Ypsilanti, Michigan, United States, 48197
        • GSK Investigational Site
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • GSK Investigational Site
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • GSK Investigational Site
      • Rolla, Missouri, United States, 65401
        • GSK Investigational Site
      • Warrensburg, Missouri, United States, 64093
        • GSK Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • GSK Investigational Site
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • GSK Investigational Site
      • Ocean, New Jersey, United States, 07712
        • GSK Investigational Site
    • New York
      • Ithaca, New York, United States, 14850
        • GSK Investigational Site
      • Mineola, New York, United States, 11501
        • GSK Investigational Site
      • Utica, New York, United States, 13502
        • GSK Investigational Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • GSK Investigational Site
      • Raleigh, North Carolina, United States, 27607
        • GSK Investigational Site
    • Ohio
      • Canton, Ohio, United States, 44718
        • GSK Investigational Site
      • Cincinnati, Ohio, United States, 45231
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • GSK Investigational Site
    • Oregon
      • Lake Oswego, Oregon, United States, 97035
        • GSK Investigational Site
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16601
        • GSK Investigational Site
      • Cranberry Township, Pennsylvania, United States, 16066
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15241
        • GSK Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • GSK Investigational Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37922
        • GSK Investigational Site
      • Nashville, Tennessee, United States, 37203-1424
        • GSK Investigational Site
    • Texas
      • Dallas, Texas, United States, 75246
        • GSK Investigational Site
      • Dallas, Texas, United States, 75231
        • GSK Investigational Site
      • El Paso, Texas, United States, 79925
        • GSK Investigational Site
      • El Paso, Texas, United States, 79902
        • GSK Investigational Site
    • Wisconsin
      • Greenfield, Wisconsin, United States, 53228
        • GSK Investigational Site
      • Madison, Wisconsin, United States, 53792
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Diagnosis of seasonal allergic rhinitis.
  • Adequate exposure to seasonal (Spring/Summer) allergen prevalent to the geographic area.

Exclusion criteria:

  • Have significant concomitant medical conditions.
  • Use of corticosteroids, other allergy meds during the study.
  • Have abnormal ECG or laboratory abnormality.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Improvement in daily, reflective total nasal symptom scores after 2 weeks of treatment in subjects ages 6 to <12 years.

Secondary Outcome Measures

Outcome Measure
Improvement in AM, pre-dose, instantaneous total nasal symptom scores after 2 weeks of treatment, overall evaluation of response to therapy after 2 weeks of treatment for subjects ages 6 to <12 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

April 7, 2005

First Submitted That Met QC Criteria

April 7, 2005

First Posted (Estimate)

April 8, 2005

Study Record Updates

Last Update Posted (Estimate)

September 15, 2016

Last Update Submitted That Met QC Criteria

September 13, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FFR100010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Study Data/Documents

  1. Clinical Study Report
    Information identifier: FFR100010
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Study Protocol
    Information identifier: FFR100010
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Individual Participant Data Set
    Information identifier: FFR100010
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Dataset Specification
    Information identifier: FFR100010
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Informed Consent Form
    Information identifier: FFR100010
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Statistical Analysis Plan
    Information identifier: FFR100010
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Annotated Case Report Form
    Information identifier: FFR100010
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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