NCT00358475

Brief Summary

This study was designed to assess safety of an investigational nasal spray in the treatment of perennial allergic rhinitis. Perennial allergic rhinitis is triggered by house dust, mite and mold etc. Typical symptoms are sneezing, nasal congestion and pruritus and rhinorrhea.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 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

June 21, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 31, 2006

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

3 months

First QC Date

July 27, 2006

Last Update Submit

August 30, 2018

Conditions

Rhinitis, Allergic, Seasonal

Keywords

perennial allergic rhinitis

Outcome Measures

Primary Outcomes (1)

  • Adverse events and laboratory blood test

Secondary Outcomes (1)

  • Change of nasal symptom score

Interventions

GW685698DRUG

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 perennial 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Location

MeSH Terms

Conditions

Rhinitis, Allergic, SeasonalRhinitis, Allergic, Perennial

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
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2006

First Posted

July 31, 2006

Study Start

June 21, 2005

Primary Completion

October 1, 2005

Study Completion

October 12, 2005

Last Updated

August 31, 2018

Record last verified: 2018-08