Hayfever, Rhinitis, Allergic, Seasonal, Seasonal Allergic Rhinitis
Conditions
Keywords
GW685698X, once daily, mountain cedar, allergic rhinitis, fluticasone furoate
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.
Interventions
DRUGfluticasone furoate
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline over the entire treatment period in daily, reflective, total nasal symptom scores. | — |
| Mean change from baseline over the entire treatment period in the daily, reflective, total ocular symptom score. | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change from baseline over the entire treatment period in AM, pre-dose, instantaneous, total nasal symptom score. | — |
Countries
United States
Outcome results
None listed