Study In Adults And Adolescents With Seasonal Allergic Rhinitis.

September 13, 2016 updated by: GlaxoSmithKline

A Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Multicentre Two Week Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg in Adult and Adolescent Subjects With Seasonal Allergic Rhinitis in Europe

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)

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

  • Estonia
      • Tallinn, Estonia, 13419
        • GSK Investigational Site
      • Tartu, Estonia, 51014
        • GSK Investigational Site
  • Latvia
      • Liepaja, Latvia, LV3401
        • GSK Investigational Site
      • Riga, Latvia, LV 1002
        • GSK Investigational Site
      • Riga, Latvia, LV 1003
        • GSK Investigational Site
      • Riga, Latvia, LV 1004
        • GSK Investigational Site
      • Riga, Latvia, LV 1001
        • GSK Investigational Site
  • Lithuania
      • Kaunas, Lithuania, LT-50009
        • GSK Investigational Site
      • Kaunas, Lithuania, LT-50425
        • GSK Investigational Site
      • Siauliai, Lithuania, LT-78242
        • GSK Investigational Site
      • Vilnius, Lithuania, LT-08661
        • GSK Investigational Site
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • GSK Investigational Site
      • Arnhem, Netherlands, 6824 BJ
        • GSK Investigational Site
      • Assen, Netherlands, 9401 RK
        • GSK Investigational Site
      • Leeuwarden, Netherlands, 8934 AD
        • GSK Investigational Site
      • Schiedam, Netherlands, 3116 BA
        • GSK Investigational Site
      • Tilburg, Netherlands, 5038 NM
        • GSK Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 115446
        • GSK Investigational Site
      • Saint-Petersburg, Russian Federation, 190013
        • GSK Investigational Site
      • Volgograd, Russian Federation, 400130
        • GSK Investigational Site
  • Sweden
      • Lund, Sweden, SE-221 85
        • GSK Investigational Site
      • Malmö, Sweden, SE-211 36
        • GSK Investigational Site
      • Västerås, Sweden, SE-721 89
        • GSK Investigational Site
      • Ängelholm, Sweden, SE-262 81
        • 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:

  • Informed consent.
  • Must be an outpatient.
  • Females must be using appropriate contraception.
  • Must have diagnosis of seasonal allergic rhinitis, adequate exposure to allergen.
  • Must be able to comply with study procedures.
  • Must be literate.

Exclusion criteria:

  • A significant concomitant medical condition.
  • Use of corticosteroids or allergy or 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 Assignment
  • 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 (rTNSS).

Secondary Outcome Measures

Outcome Measure
Mean change from baseline over the entire tx period in AM, pre-dose iTNS. Mean change from baseline over the entire treatment period in rTOSS. Overall evaluation of response to therapy.

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

May 1, 2005

Primary Completion (Actual)

August 1, 2005

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

September 22, 2005

First Submitted That Met QC Criteria

September 22, 2005

First Posted (Estimate)

September 26, 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

  • FFR103184

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. Statistical Analysis Plan
    Information identifier: FFR103184
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Dataset Specification
    Information identifier: FFR103184
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Annotated Case Report Form
    Information identifier: FFR103184
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Individual Participant Data Set
    Information identifier: FFR103184
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Clinical Study Report
    Information identifier: FFR103184
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Study Protocol
    Information identifier: FFR103184
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Informed Consent Form
    Information identifier: FFR103184
    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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