Study Of Perennial Allergic Rhinitis
Primary Purpose
Rhinitis, Allergic, Seasonal
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
GW685698
Sponsored by
About this trial
This is an interventional treatment trial for Rhinitis, Allergic, Seasonal focused on measuring perennial allergic rhinitis
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.
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
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
Learn more about this trial
Study Of Perennial Allergic Rhinitis
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