Study In Adults And Adolescents With Seasonal Allergic Rhinitis

August 30, 2016 updated by: GlaxoSmithKline

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 14 Days in Adult and Adolescent Subjects With Seasonal Allergic Rhinitis

The purpose of the study is to compare the efficacy and safety of an investigational nasal spray compared with placebo nasal spray in the treatment of seasonal allergic rhinitis. Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. The focus of this study, seasonal allergic rhinitis (SAR), is one type of allergic rhinitis that is triggered by the pollen from trees, grasses, and weeds. Commonly referred to as "hay fever", it is characterized by sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

304

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
    • Texas
      • Austin, Texas, United States, 78731
        • GSK Investigational Site
      • Austin, Texas, United States, 78759
        • GSK Investigational Site
      • New Braunfels, Texas, United States, 78130
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78229
        • 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 (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Informed consent.
  • Outpatient.
  • Females must use appropriate contraception.
  • Diagnosis of seasonal allergic rhinitis.
  • Adequate exposure to allergen.
  • Able to comply with study procedures.
  • Literate.

Exclusion criteria:

  • Significant concomitant medical condition.
  • Use of corticosteroids, allergy medications, or tobacco.
  • Clinically significant abnormal ECG.
  • Laboratory abnormality.
  • Positive pregnancy test.
  • Allergy to any component of the investigational product.

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
  • Masking: DOUBLE

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.
Mean change from baseline over the entire treatment period in the daily, reflective, total ocular symptom score.

Secondary Outcome Measures

Outcome Measure
Mean change from baseline over the entire treatment period in AM, pre-dose, instantaneous, total nasal symptom score.

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

December 1, 2004

Primary Completion (ACTUAL)

January 1, 2005

Study Completion (ACTUAL)

January 1, 2005

Study Registration Dates

First Submitted

June 23, 2005

First Submitted That Met QC Criteria

June 23, 2005

First Posted (ESTIMATE)

June 24, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

September 1, 2016

Last Update Submitted That Met QC Criteria

August 30, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FFR30003

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. Annotated Case Report Form
    Information identifier: FFR30003
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Dataset Specification
    Information identifier: FFR30003
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Clinical Study Report
    Information identifier: FFR30003
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Informed Consent Form
    Information identifier: FFR30003
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Statistical Analysis Plan
    Information identifier: FFR30003
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Study Protocol
    Information identifier: FFR30003
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Individual Participant Data Set
    Information identifier: FFR30003
    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.

Clinical Trials on Rhinitis, Allergic, Seasonal

Clinical Trials on fluticasone furoate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zimbabwe

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe