Clinical trial NCT00115622: Study In Adults And Adolescents With Seasonal Allergic Rhinitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hayfever
Rhinitis, Allergic, Seasonal
Seasonal Allergic Rhinitis
Keywords: GW685698X
once daily
mountain cedar
allergic rhinitis
fluticasone furoate
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-06-24
Enrollment: 304
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Mean change from baseline over the entire treatment period in daily, reflective, total nasal symptom scores.
measure: Mean change from baseline over the entire treatment period in the daily, reflective, total ocular symptom score.
Secondary outcomes:
measure: Mean change from baseline over the entire treatment period in AM, pre-dose, instantaneous, total nasal symptom score.
Other outcomes:
Locations:
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: New Braunfels
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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
citation: Jacobs R, Martin B, Hampel F, Toler W, Ellsworth A, Philpot E. Effectiveness of fluticasone furoate 110 microg 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 Jun;25(6):1393-401. doi: 10.1185/03007990902890512.
citation: 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
citation: 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