NCT00225823

Brief Summary

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

93
On Track

Trial Health Score

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

Enrollment
288

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2005

Shorter than P25 for phase_3

Geographic Reach
6 countries

24 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

May 1, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 26, 2005

Completed
Last Updated

September 15, 2016

Status Verified

September 1, 2016

Enrollment Period

3 months

First QC Date

September 22, 2005

Last Update Submit

September 13, 2016

Conditions

Rhinitis, Allergic, Seasonal

Keywords

Seasonal Allergic Rhinitis Intranasal Corticosteroid

Outcome Measures

Primary Outcomes (1)

  • Mean change from baseline over the entire treatment period in daily, reflective, total nasal symptom scores (rTNSS).

Secondary Outcomes (1)

  • 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.

Interventions

GW685698XDRUG

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

GSK Investigational Site

Tallinn, 13419, Estonia

Location

GSK Investigational Site

Tartu, 51014, Estonia

Location

GSK Investigational Site

Liepāja, LV3401, Latvia

Location

GSK Investigational Site

Riga, LV 1001, Latvia

Location

GSK Investigational Site

Riga, LV 1002, Latvia

Location

GSK Investigational Site

Riga, LV 1003, Latvia

Location

GSK Investigational Site

Riga, LV 1004, Latvia

Location

GSK Investigational Site

Kaunas, LT-50009, Lithuania

Location

GSK Investigational Site

Kaunas, LT-50425, Lithuania

Location

GSK Investigational Site

Šiauliai, LT-78242, Lithuania

Location

GSK Investigational Site

Vilnius, LT-08661, Lithuania

Location

GSK Investigational Site

Amsterdam, 1105 AZ, Netherlands

Location

GSK Investigational Site

Arnhem, 6824 BJ, Netherlands

Location

GSK Investigational Site

Assen, 9401 RK, Netherlands

Location

GSK Investigational Site

Leeuwarden, 8934 AD, Netherlands

Location

GSK Investigational Site

Schiedam, 3116 BA, Netherlands

Location

GSK Investigational Site

Tilburg, 5038 NM, Netherlands

Location

GSK Investigational Site

Moscow, 115446, Russia

Location

GSK Investigational Site

Saint Petersburg, 190013, Russia

Location

GSK Investigational Site

Volgograd, 400130, Russia

Location

GSK Investigational Site

Ängelholm, SE-262 81, Sweden

Location

GSK Investigational Site

Lund, SE-221 85, Sweden

Location

GSK Investigational Site

Malmo, SE-211 36, Sweden

Location

GSK Investigational Site

Västerås, SE-721 89, Sweden

Location

Related Links

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose 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
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2005

First Posted

September 26, 2005

Study Start

May 1, 2005

Primary Completion

August 1, 2005

Study Completion

August 1, 2005

Last Updated

September 15, 2016

Record last verified: 2016-09

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

Statistical Analysis Plan (FFR103184)Access
Dataset Specification (FFR103184)Access
Annotated Case Report Form (FFR103184)Access
Individual Participant Data Set (FFR103184)Access
Clinical Study Report (FFR103184)Access
Study Protocol (FFR103184)Access
Informed Consent Form (FFR103184)Access

Locations

NL(6)SE(4)LA(5)ES(2)RU(3)LI(4)