Seasonal Allergic Rhinitis In Pediatric Subjects

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00107757
First received: April 7, 2005
Last updated: March 1, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention Phase
Seasonal Allergic Rhinitis
Drug: GW685698X
Phase 3

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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 576
Study Start Date: March 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   2 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00107757

  Hide Study Locations
Locations
United States, Arizona
GSK Clinical Trials Call Center
Scottsdale, Arizona, United States, 85251
United States, Arkansas
GSK Clinical Trials Call Center
Little Rock, Arkansas, United States, 72202
United States, California
GSK Clinical Trials Call Center
Costa Mesa, California, United States, 92626
GSK Clinical Trials Call Center
Cudahy, California, United States, 90201
GSK Clinical Trials Call Center
Huntington Beach, California, United States, 92647
GSK Clinical Trials Call Center
Mission Viejo, California, United States, 92691
GSK Clinical Trials Call Center
Orange, California, United States, 92868
GSK Clinical Trials Call Center
Riverside, California, United States, 92805
GSK Clinical Trials Call Center
San Diego, California, United States, 92123
GSK Clinical Trials Call Center
Walnut Creek, California, United States, 94598
United States, Colorado
GSK Clinical Trials Call Center
Cenntenial, Colorado, United States, 80112
GSK Clinical Trials Call Center
Denver, Colorado, United States, 80206
GSK Clinical Trials Call Center
Englewood, Colorado, United States, 80112
GSK Clinical Trials Call Center
Fort Collins, Colorado, United States, 80526
GSK Clinical Trials Call Center
Lakewood, Colorado, United States, 80401
United States, Florida
GSK Clinical Trials Call Center
Miami, Florida, United States, 33176
GSK Clinical Trials Call Center
Tampa, Florida, United States, 33613
United States, Georgia
GSK Clinical Trials Call Center
Gainesville, Georgia, United States, 30501
GSK Clinical Trials Call Center
Lawrenceville, Georgia, United States, 30045
GSK Clinical Trials Call Center
Lilburn, Georgia, United States, 30047
GSK Clinical Trials Call Center
Stockbridge, Georgia, United States, 30281
GSK Clinical Trials Call Center
Woodstock, Georgia, United States, 30188
United States, Indiana
GSK Clinical Trials Call Center
Indianapolis, Indiana, United States, 46208
United States, Louisiana
GSK Clinical Trials Call Center
Metairie, Louisiana, United States, 70006
GSK Clinical Trials Call Center
Shreveport, Louisiana, United States, 71105
United States, Maryland
GSK Clinical Trials Call Center
Baltimore, Maryland, United States, 21236
GSK Clinical Trials Call Center
Bethesda, Maryland, United States, 20814
GSK Clinical Trials Call Center
Rockville, Maryland, United States, 20850
United States, Massachusetts
GSK Clinical Trials Call Center
Brockton, Massachusetts, United States, 02301
GSK Clinical Trials Call Center
North Dartmouth, Massachusetts, United States, 02747
GSK Clinical Trials Call Center
Springfield, Massachusetts, United States, 01107
United States, Michigan
GSK Clinical Trials Call Center
Richland, Michigan, United States, 49083
GSK Clinical Trials Call Center
Ypsilanti, Michigan, United States, 48197
United States, Mississippi
GSK Clinical Trials Call Center
Jackson, Mississippi, United States, 39202
United States, Missouri
GSK Clinical Trials Call Center
Kansas City, Missouri, United States, 64108-9898
GSK Clinical Trials Call Center
Rolla, Missouri, United States, 65401
GSK Clinical Trials Call Center
Warrensburg, Missouri, United States, 64093
United States, Nebraska
GSK Clinical Trials Call Center
Omaha, Nebraska, United States, 68130
United States, New Jersey
GSK Clinical Trials Call Center
Hackensack, New Jersey, United States, 07601
United States, New York
GSK Clinical Trials Call Center
Cortland, New York, United States, 13045
GSK Clinical Trials Call Center
Mineola, New York, United States, 11501
GSK Clinical Trials Call Center
Utica, New York, United States, 13502
United States, North Carolina
GSK Clinical Trials Call Center
Durham, North Carolina, United States, 27710
GSK Clinical Trials Call Center
Raleigh, North Carolina, United States, 27607
United States, Ohio
GSK Clinical Trials Call Center
Canton, Ohio, United States, 44718
GSK Clinical Trials Call Center
Cincinnati, Ohio, United States, 45231
United States, Oklahoma
GSK Clinical Trials Call Center
Oklahoma City, Oklahoma, United States, 73120
United States, Oregon
GSK Clinical Trials Call Center
Lake Oswego, Oregon, United States, 97035
United States, Pennsylvania
GSK Clinical Trials Call Center
Altoona, Pennsylvania, United States, 16601
GSK Clinical Trials Call Center
Bellevue, Pennsylvania, United States, 15202
GSK Clinical Trials Call Center
Pittsburgh, Pennsylvania, United States, 15241-1080
United States, South Carolina
GSK Clinical Trials Call Center
Charleston, South Carolina, United States, 29406
United States, Tennessee
GSK Clinical Trials Call Center
Knoxville, Tennessee, United States, 37922
GSK Clinical Trials Call Center
Nashville, Tennessee, United States, 37203
United States, Texas
GSK Clinical Trials Call Center
El Paso, Texas, United States, 79902
GSK Clinical Trials Call Center
El Paso, Texas, United States, 79925
United States, Wisconsin
GSK Clinical Trials Call Center
Greenfield, Wisconsin, United States, 53228
GSK Clinical Trials Call Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00107757     History of Changes
Other Study ID Numbers: FFR100010
Study First Received: April 7, 2005
Last Updated: March 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Seasonal allergic rhinitis
pediatric

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

ClinicalTrials.gov processed this record on September 18, 2014