NCT00115622

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
304

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2004

Shorter than P25 for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 24, 2005

Completed
Last Updated

September 1, 2016

Status Verified

August 1, 2016

Enrollment Period

1 month

First QC Date

June 23, 2005

Last Update Submit

August 30, 2016

Conditions

HayfeverRhinitis, Allergic, SeasonalSeasonal Allergic Rhinitis

Keywords

GW685698Xonce dailymountain cedarallergic rhinitisfluticasone furoate

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

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

Interventions

fluticasone furoateDRUG

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

GSK Investigational Site

Austin, Texas, 78731, United States

Location

GSK Investigational Site

Austin, Texas, 78759, United States

Location

GSK Investigational Site

New Braunfels, Texas, 78130, United States

Location

GSK Investigational Site

San Antonio, Texas, 78229, United States

Location

Related Publications (4)

  • Hampel FC Jr, Jacobs R, Martin B. Toler T, Ellsworth A, Philpot E. Once-daily fluticasone furoate* nasal spray (FF) provides 24-hour symptom relief in subjects with seasonal allergic rhinitis (SAR) caused by mountain cedar pollen. *USAN approved name. J

    BACKGROUND

  • Jacobs R, Martin B, Hampel F, Toler W, Ellsworth A, Philpot E. Effectiveness of fluticasone furoate 110 microg once daily in the treatment of nasal and ocular symptoms of seasonal allergic rhinitis in adults and adolescents sensitized to mountain cedar pollen. Curr Med Res Opin. 2009 Jun;25(6):1393-401. doi: 10.1185/03007990902890512.

    PMID: 19419338BACKGROUND

  • Ratner P, Andrews C, van Bavel J, Toler T, Ellsworth A, Philpot E. Once-daily fluticasone furoate* nasal spray (FF) effectively treats ocular symptoms of seasonal allergic rhinitis (SAR) caused by mountain cedar pollen. *USAN approved name. J Allergy Cli

    BACKGROUND

  • van Bavel J, Toler T, Ellsworth A, Stanford R, Philpot E. Once-daily fluticasone furoate* nasal spray (FFNS) improves quality of life (QoL) in subjects with seasonal allergic rhinitis (SAR) during the mountain cedar pollen season. *USAN approved name. J

    BACKGROUND

Related Links

MeSH Terms

Conditions

Rhinitis, Allergic, SeasonalRhinitis, Allergic

Interventions

fluticasone furoate

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2005

First Posted

June 24, 2005

Study Start

December 1, 2004

Primary Completion

January 1, 2005

Study Completion

January 1, 2005

Last Updated

September 1, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Available IPD Datasets

Annotated Case Report Form (FFR30003)Access
Dataset Specification (FFR30003)Access
Clinical Study Report (FFR30003)Access
Informed Consent Form (FFR30003)Access
Statistical Analysis Plan (FFR30003)Access
Study Protocol (FFR30003)Access
Individual Participant Data Set (FFR30003)Access

Locations

US(4)