NCT00363740

Brief Summary

This study was designed to compare the efficacy and safety of an investigational nasal spray compared with placebo nasal spray and commonly used drug 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. Typical symptoms are sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2005

Shorter than P25 for phase_3

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

February 19, 2005

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2005

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 15, 2006

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

1 month

First QC Date

August 11, 2006

Last Update Submit

August 30, 2018

Conditions

Rhinitis, Allergic, Seasonal

Keywords

GW685698Xallergic rhinitisSeasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

  • Mean change from baseline over the entire treatment period in three total nasal symptom scores.

Secondary Outcomes (2)

  • Mean change from baseline over the entire treatment period in four total nasal symptom scores.

  • Mean change from baseline over the entire treatment period in individual total nasal symptom scores.

Interventions

GW685698X Aqueous Nasal SprayDRUG

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent
  • Outpatient
  • Diagnosis of seasonal allergic rhinitis with symptoms
  • Able to comply with study procedures

You may not qualify if:

  • Significant concomitant medical condition
  • Use of corticosteroids/allergy medications
  • Laboratory abnormality
  • Positive pregnancy test
  • Allergy to any component of investigational product

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Location

MeSH Terms

Conditions

Rhinitis, Allergic, SeasonalRhinitis, Allergic

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

Study Record Dates

First Submitted

August 11, 2006

First Posted

August 15, 2006

Study Start

February 19, 2005

Primary Completion

April 1, 2005

Study Completion

April 13, 2005

Last Updated

August 31, 2018

Record last verified: 2018-08