Back to resultsStudy of GW685698X In Patients With Seasonal Allergic Rhinitis
Primary Purpose
Rhinitis, Allergic, Seasonal
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
GW685698X Aqueous Nasal Spray
Sponsored by
About this trial
This is an interventional treatment trial for Rhinitis, Allergic, Seasonal focused on measuring GW685698X, allergic rhinitis, Seasonal Allergic Rhinitis
Eligibility Criteria
Inclusion criteria: Informed consent Outpatient Diagnosis of seasonal 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 Allergy to any component of investigational product
Sites / Locations
- GSK Investigational Site
Outcomes
Primary Outcome Measures
Mean change from baseline over the entire treatment period in three total nasal symptom scores.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00363740
Brief Title
Study of GW685698X In Patients With Seasonal Allergic Rhinitis
Official Title
Clinical Evaluation of GW685698 for Seasonal Allergic Rhinitis -A Placebo-controlled Study to Determine the Non-inferiority of GW685698 Over Fluticasone Propionate Using a Double-blind Manner-
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 19, 2005 (undefined)
Primary Completion Date
April 1, 2005 (Actual)
Study Completion Date
April 13, 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Allergic, Seasonal
Keywords
GW685698X, allergic rhinitis, Seasonal Allergic Rhinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
GW685698X Aqueous Nasal Spray
Primary Outcome Measure Information:
Title
Mean change from baseline over the entire treatment period in three total nasal symptom scores.
Secondary Outcome Measure Information:
Title
Mean change from baseline over the entire treatment period in four total nasal symptom scores.
Title
Mean change from baseline over the entire treatment period in individual total nasal symptom scores.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Informed consent
Outpatient
Diagnosis of seasonal 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
Allergy to any component of investigational product
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 GW685698X In Patients With Seasonal Allergic Rhinitis
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