Perennial Allergic Rhinitis Study In Pediatric Subjects

January 18, 2017 updated by: GlaxoSmithKline

A Two Week Randomized, Double Blind Placebo Controlled, Parallel Group Study of GW685698X Aqueous Nasal Spray 100mcg and 50mcg QD in Pediatric Subjects With Perennial Allergic Rhinitis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

558

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

  • Argentina
      • Buenos Aires, Argentina, 1425
        • GSK Investigational Site
      • Santa Fe, Argentina, 3000
        • GSK Investigational Site
    • Buenos Aires
      • Nueve de Julio, Buenos Aires, Argentina, B6500BWQ
        • GSK Investigational Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2000
        • GSK Investigational Site
  • Chile
    • Región Metro De Santiago
      • Santiago, Región Metro De Santiago, Chile
        • GSK Investigational Site
    • Valparaíso
      • Viña del Mar, Valparaíso, Chile
        • GSK Investigational Site
  • Finland
      • Joensuu, Finland, 80100
        • GSK Investigational Site
      • Nokia, Finland, 37100
        • GSK Investigational Site
      • Tampere, Finland, 33200
        • GSK Investigational Site
      • Turku, Finland, 20610
        • GSK Investigational Site
  • Italy
      • Bari, Italy, 70124
        • GSK Investigational Site
      • Milano, Italy, 52-20129
        • GSK Investigational Site
      • Monticelli Ascoli Piceno, Italy, 63100
        • GSK Investigational Site
      • Perugia, Italy, 06126
        • GSK Investigational Site
      • Salerno, Italy, 84100
        • GSK Investigational Site
    • Campania
      • Napoli, Campania, Italy, 80138
        • GSK Investigational Site
  • Mexico
      • Mexico, Mexico, 04530
        • GSK Investigational Site
      • Mexico, Mexico, 6720
        • GSK Investigational Site
      • Monterrey, N.L, Mexico, 64460
        • GSK Investigational Site
  • Slovakia
      • Banska Bystrica, Slovakia, 974 01
        • GSK Investigational Site
      • Bratislava, Slovakia, 821 06
        • GSK Investigational Site
      • Levoca, Slovakia, 054 01
        • GSK Investigational Site
      • Nitra, Slovakia, 949 01
        • GSK Investigational Site
  • United States
    • California
      • Costa Mesa, California, United States, 92626
        • GSK Investigational Site
      • Cudahy, California, United States, 90201
        • GSK Investigational Site
      • Long Beach, California, United States, 90808
        • GSK Investigational Site
      • Long Beach, California, United States, 90806
        • GSK Investigational Site
      • Orange, California, United States, 92868
        • GSK Investigational Site
      • Riverside, California, United States, 92506
        • GSK Investigational Site
      • Sacramento, California, United States, 95819
        • GSK Investigational Site
      • San Diego, California, United States, 92123
        • GSK Investigational Site
      • San Diego, California, United States, 92120
        • GSK Investigational Site
      • Walnut Creek, California, United States, 94598
        • GSK Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80206
        • GSK Investigational Site
      • Denver, Colorado, United States, 80230
        • GSK Investigational Site
      • Englewood, Colorado, United States, 80112
        • GSK Investigational Site
    • Florida
      • Coral Gables, Florida, United States, 33134
        • GSK Investigational Site
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • GSK Investigational Site
      • Lawrenceville, Georgia, United States, 30045
        • GSK Investigational Site
      • Stockbridge, Georgia, United States, 30281
        • 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
    • Michigan
      • 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
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • GSK Investigational Site
      • Omaha, Nebraska, United States, 68130
        • GSK Investigational Site
    • New Jersey
      • Brick, New Jersey, United States, 8724
        • GSK Investigational Site
    • New York
      • Ithaca, New York, United States, 14850
        • GSK Investigational Site
      • Liverpool, New York, United States, 13090
        • GSK Investigational Site
      • Rochester, New York, United States, 14618
        • GSK Investigational Site
      • Rochester, New York, United States, 14627
        • GSK Investigational Site
      • Utica, New York, United States, 13502
        • GSK Investigational Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • GSK Investigational Site
    • Ohio
      • 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
      • Medford, Oregon, United States, 97504
        • GSK Investigational Site
    • Pennsylvania
      • Bellevue, Pennsylvania, United States, 15202
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15241
        • GSK Investigational Site
      • Upland, Pennsylvania, United States, 19013
        • GSK Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • GSK Investigational Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37922
        • GSK Investigational Site
      • Nashville, Tennessee, United States, 37203-1424
        • GSK Investigational Site
    • Texas
      • El Paso, Texas, United States, 79902
        • 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 perennial allergic rhinitis.

Exclusion criteria:

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

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 first 4-week treatment period in subjects ages 6 to <12 years.

Secondary Outcome Measures

Outcome Measure
Improvement in AM, pre-dose, instantaneous total nasal symptom scores after first 4-week treatment period, overall evaluation of response to therapy for the first 4-week treatment period 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.

General Publications

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

February 1, 2005

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

April 20, 2005

First Submitted That Met QC Criteria

April 20, 2005

First Posted (Estimate)

April 21, 2005

Study Record Updates

Last Update Posted (Estimate)

January 19, 2017

Last Update Submitted That Met QC Criteria

January 18, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FFR30008

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. Individual Participant Data Set
    Information identifier: FFR30008
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Annotated Case Report Form
    Information identifier: FFR30008
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Clinical Study Report
    Information identifier: FFR30008
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Informed Consent Form
    Information identifier: FFR30008
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Statistical Analysis Plan
    Information identifier: FFR30008
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Study Protocol
    Information identifier: FFR30008
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Dataset Specification
    Information identifier: FFR30008
    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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