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Study Of Perennial Allergic Rhinitis

Primary Purpose

Rhinitis, Allergic, Seasonal

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
GW685698
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinitis, Allergic, Seasonal focused on measuring perennial allergic rhinitis

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: Informed consent. Outpatient. Diagnosis of perennial allergic rhinitis with symptoms. Able to comply with study procedures. Exclusion criteria: Significant concomitant medical condition. Use of corticosteroids/allergy medications. Laboratory abnormality. Positive pregnancy test.

Sites / Locations

  • GSK Investigational Site

Outcomes

Primary Outcome Measures

Adverse events and laboratory blood test

Secondary Outcome Measures

Change of nasal symptom score

Full Information

First Posted
July 27, 2006
Last Updated
August 30, 2018
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00358475
Brief Title
Study Of Perennial Allergic Rhinitis
Official Title
Study of Perennial Allergic Rhinitis -Long Term Treatment Study-
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 21, 2005 (undefined)
Primary Completion Date
October 1, 2005 (Actual)
Study Completion Date
October 12, 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Allergic, Seasonal
Keywords
perennial allergic rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
GW685698
Primary Outcome Measure Information:
Title
Adverse events and laboratory blood test
Secondary Outcome Measure Information:
Title
Change of nasal symptom score

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Informed consent. Outpatient. Diagnosis of perennial allergic rhinitis with symptoms. Able to comply with study procedures. Exclusion criteria: Significant concomitant medical condition. Use of corticosteroids/allergy medications. Laboratory abnormality. Positive pregnancy test.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site

12. IPD Sharing Statement

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Study Of Perennial Allergic Rhinitis

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