Last updated: 11/07/2018 16:44:32
Once-Daily Investigational Nasal Spray In Adults And Adolescents With Seasonal Allergic Rhinitis (SAR)
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Randomized, Single-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100 mcg for 2 Weeks in Adult and Adolescent Subjects with Seasonal Allergic Rhinitis
Trial description: 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. Commonly referred to as (hay fever), it is characterized by sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes. The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with seasonal allergic rhinitis (SAR) caused by ragweed pollen.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: GW685698X Aqueous Nasal Spray
Enrollment:
288
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Kaiser HB, Naclerio RM, Given J, Philpot E, Toler T, Ellsworth A. Once-daily fluticasone furoate* nasal spray (FFNS) is effective for the treatment of seasonal allergic rhinitis (SAR) caused by ragweed. *USAN-approved name. J Allergy Clin Immunol. 2007;
Kaiser HB, Naclerio RM, Given J, Toler T, Ellsworth A, Philpot EE. Fluticasone furoate nasal spray: A single treatment option for the symptoms of seasonal allergic rhinitis. J Allergy Clin Immunol 2007;119:1430-1437.
Naclerio R, Kaiser H, Lumry W, Philpot E, Toler T, Ellsworth A. Fluticasone furoate nasal spray provided 24-hr relief of nasal and ocular symptoms of seasonal allergic rhinitis (SAR) caused by ragweed. Allergy 2007;62(Suppl. 83): 134 (abstract).
Medical condition
Rhinitis, Allergic, Seasonal
Product
fluticasone furoate
Collaborators
Not applicable
Study date(s)
August 2005 to October 2005
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
- Must be outpatients.
- Diagnosis of SAR.
- Have a significant concomitant medical condition.
- Use corticosteroids or other allergy medications during the study.
Inclusion and exclusion criteria
Inclusion criteria:
- Must be outpatients.
- Diagnosis of SAR.
- Literate in English or native language.
Exclusion criteria:
- Have a significant concomitant medical condition.
- Use corticosteroids or other allergy medications during the study.
- Use tobacco products.
Trial location(s)
Location
GSK Investigational Site
Columbia, Missouri, United States, 65203
Status
Study Complete
Location
GSK Investigational Site
West Allis, Wisconsin, United States, 53227
Status
Study Complete
Location
GSK Investigational Site
Dallas, Texas, United States, 75231-4307
Status
Study Complete
Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Status
Study Complete
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55402
Status
Study Complete
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46208
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63141
Status
Study Complete
Location
GSK Investigational Site
Lincoln, Nebraska, United States, 68505
Status
Study Complete
Location
GSK Investigational Site
Greenfield, Wisconsin, United States, 53228
Status
Study Complete
Location
GSK Investigational Site
Lafayette, Indiana, United States, 47904
Status
Study Complete
Location
GSK Investigational Site
Papillion, Nebraska, United States, 68046
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60637
Status
Study Complete
Location
GSK Investigational Site
Louisville, Kentucky, United States, 40215
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2005-18-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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