A Study To Evaluate The Efficacy And Safety Of A Once-Daily Investigational Nasal Spray In Adults And Adolescents With Perennial Allergic Rhinitis (PAR).

September 15, 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 100mcg for 4 Weeks in Adult and Adolescent Subjects (12 Years of Age and Older) With Perennial Allergic Rhinitis (PAR)

The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with perennial allergic rhinitis (PAR).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 100mcg for 4 Weeks in Adult and Adolescent Subjects (12 years of age and older) with Perennial Allergic Rhinitis (PAR)

Study Type

Interventional

Enrollment (Actual)

288

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

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 9L8
        • GSK Investigational Site
      • Vancouver, British Columbia, Canada, V5Z 4E1
        • GSK Investigational Site
    • Ontario
      • Mississauga, Ontario, Canada, L5A 1N1
        • GSK Investigational Site
      • Ottawa, Ontario, Canada, K1Y 4G2
        • GSK Investigational Site
    • Quebec
      • Québec, Quebec, Canada, G1V 4M6
        • GSK Investigational Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7H 0V1
        • GSK Investigational Site
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • GSK Investigational Site
    • California
      • Los Angeles, California, United States, 90025
        • GSK Investigational Site
      • Mission Viejo, California, United States, 92691
        • GSK Investigational Site
      • Orange, California, United States, 92868
        • GSK Investigational Site
      • San Diego, California, United States, 92123
        • GSK Investigational Site
      • San Diego, California, United States, 92120
        • GSK Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • GSK Investigational Site
    • Florida
      • Miami, Florida, United States, 33173
        • GSK Investigational Site
      • Miami, Florida, United States, 33176
        • GSK Investigational Site
      • Tallahassee, Florida, United States, 32308
        • GSK Investigational Site
      • Tampa, Florida, United States, 33613
        • GSK Investigational Site
      • Vero Beach, Florida, United States, 32960
        • GSK Investigational Site
    • Georgia
      • Lawrenceville, Georgia, United States, 30045
        • GSK Investigational Site
      • Lilburn, Georgia, United States, 30047
        • GSK Investigational Site
    • Indiana
      • South Bend, Indiana, United States, 46617
        • GSK Investigational Site
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • GSK Investigational Site
    • Maine
      • Portland, Maine, United States, 04102
        • GSK Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21236
        • GSK Investigational Site
      • Rockville, Maryland, United States, 20850
        • GSK Investigational Site
    • Massachusetts
      • 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
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • GSK Investigational Site
      • St. Louis, Missouri, United States, 63104
        • GSK Investigational Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68505
        • GSK Investigational Site
      • Omaha, Nebraska, United States, 68130
        • GSK Investigational Site
    • New Jersey
      • Ocean, New Jersey, United States, 07712
        • GSK Investigational Site
      • Summit, New Jersey, United States, 07091
        • GSK Investigational Site
    • North Carolina
      • 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, 73104
        • GSK Investigational Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • GSK Investigational Site
      • Lake Oswego, Oregon, United States, 97035
        • GSK Investigational Site
      • Medford, Oregon, United States, 97504
        • GSK Investigational Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • GSK Investigational Site
    • South Carolina
      • Orangeburg, South Carolina, United States, 29118
        • GSK Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203-1424
        • GSK Investigational Site
    • Texas
      • Austin, Texas, United States, 78731
        • GSK Investigational Site
      • New Braunfels, Texas, United States, 78130
        • GSK Investigational Site
    • Utah
      • Murray, Utah, United States, 84107
        • GSK Investigational Site
    • Vermont
      • South Burlington, Vermont, United States, 05403
        • GSK Investigational Site
    • Wisconsin
      • West Allis, Wisconsin, United States, 53227
        • 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

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Diagnosis of perennial allergic rhinitis (PAR).
  • Must comply with study procedures and be literate.

Exclusion criteria:

  • Significant concomitant medical conditions.
  • Use of corticosteroids.
  • Use of allergy medications and some other medications during the study.
  • Current tobacco use.
  • Clinically significant 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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Drug: GW685698X

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Mean change from baseline over the entire treatment period in daily, reflective total nasal symptom scores. Subjects complete diaries twice daily (every 12 hours) reporting the severity of their PAR symptoms.

Secondary Outcome Measures

Outcome Measure
Mean change from baseline over the entire treatment period in AM, pre-dose, instantaneous total nasal symptom scores. The subject completes an overall evaluation of response to therapy during the last clinic visit.

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

January 1, 2005

Primary Completion (Actual)

May 1, 2005

Study Completion (Actual)

May 1, 2005

Study Registration Dates

First Submitted

February 8, 2005

First Submitted That Met QC Criteria

February 8, 2005

First Posted (Estimate)

February 9, 2005

Study Record Updates

Last Update Posted (Estimate)

September 19, 2016

Last Update Submitted That Met QC Criteria

September 15, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FFR30002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Study Data/Documents

  1. Annotated Case Report Form
    Information identifier: FFR30002
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Statistical Analysis Plan
    Information identifier: FFR30002
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Informed Consent Form
    Information identifier: FFR30002
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Clinical Study Report
    Information identifier: FFR30002
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Study Protocol
    Information identifier: FFR30002
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Individual Participant Data Set
    Information identifier: FFR30002
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Dataset Specification
    Information identifier: FFR30002
    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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