Study of GW685698X In Patients With Seasonal Allergic Rhinitis
August 30, 2018 updated by: GlaxoSmithKline
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-
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Mean change from baseline over the entire treatment period in three total nasal symptom scores.
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Secondary Outcome Measures
Outcome Measure |
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Mean change from baseline over the entire treatment period in four total nasal symptom scores.
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Mean change from baseline over the entire treatment period in individual total nasal symptom scores.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 19, 2005
Primary Completion (ACTUAL)
April 1, 2005
Study Completion (ACTUAL)
April 13, 2005
Study Registration Dates
First Submitted
August 11, 2006
First Submitted That Met QC Criteria
August 11, 2006
First Posted (ESTIMATE)
August 15, 2006
Study Record Updates
Last Update Posted (ACTUAL)
August 31, 2018
Last Update Submitted That Met QC Criteria
August 30, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FFR100652
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.