Last updated: 11/04/2018 07:00:43

Study In Adults And Adolescents With Seasonal Allergic Rhinitis

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GSK study ID
FFR30003
See study documents
Clinicaltrials.gov ID
NCT00115622
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 14 days in Adult and Adolescent Subjects with Seasonal Allergic Rhinitis
Trial description: The purpose of the study is to compare the efficacy and safety of an investigational nasal spray compared with placebo nasal spray 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. Commonly referred to as "hay fever", it is characterized by sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: fluticasone furoate
Enrollment:
304
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Hampel FC Jr, Jacobs R, Martin B. Toler T, Ellsworth A, Philpot E. Once-daily fluticasone furoate* nasal spray (FF) provides 24-hour symptom relief in subjects with seasonal allergic rhinitis (SAR) caused by mountain cedar pollen. *USAN approved name. J
Jacobs R,Martin B, Hampel F, Toler WT, Ellsworth A and Philpot EE.Effectiveness of fluticasone furoate 110µg once daily in the treatment of nasal and ocular symptoms of seasonal allergic rhinitis in adults and adolescents sensitized to mountain cedar pollen.Curr Med Res Opin.2009;25(6):1393-1401
Ratner P, Andrews C, van Bavel J, Toler T, Ellsworth A, Philpot E. Once-daily fluticasone furoate* nasal spray (FF) effectively treats ocular symptoms of seasonal allergic rhinitis (SAR) caused by mountain cedar pollen. *USAN approved name. J Allergy Cli
van Bavel J, Toler T, Ellsworth A, Stanford R, Philpot E. Once-daily fluticasone furoate* nasal spray (FFNS) improves quality of life (QoL) in subjects with seasonal allergic rhinitis (SAR) during the mountain cedar pollen season. *USAN approved name. J
Medical condition
Hayfever
Product
fluticasone furoate
Collaborators
Not applicable
Study date(s)
December 2004 to January 2005
Type
Interventional
Phase
3

Participation criteria

Sex
Female & Male
Age
12 years - 0 Not applicable
Accepts healthy volunteers
No
  • Informed consent.
  • Outpatient.
  • Significant concomitant medical condition.
  • Use of corticosteroids, allergy medications, or tobacco.
Inclusion and exclusion criteria
Inclusion criteria:
  • Informed consent.
  • Outpatient.
  • Females must use appropriate contraception.
  • Diagnosis of seasonal allergic rhinitis.
  • Adequate exposure to allergen.
  • Able to comply with study procedures.
  • Literate.
Exclusion criteria:
  • Significant concomitant medical condition.
  • Use of corticosteroids, allergy medications, or tobacco.
  • Clinically significant abnormal ECG.
  • Laboratory abnormality.
  • Positive pregnancy test.
  • Allergy to any component of the investigational product.

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Austin, Texas, United States, 78759
Status
Study Complete
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Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
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Location
GSK Investigational Site
Austin, Texas, United States, 78731
Status
Study Complete
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Location
GSK Investigational Site
New Braunfels, Texas, United States, 78130
Status
Study Complete
Contact us

Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

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
2005-06-01

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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