Rhinitis, Allergic, Seasonal
Conditions
Keywords
GW685698X, allergic rhinitis, Seasonal Allergic Rhinitis
Brief summary
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.
Interventions
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline over the entire treatment period in three total nasal symptom scores. | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change from baseline over the entire treatment period in four total nasal symptom scores. | — |
| Mean change from baseline over the entire treatment period in individual total nasal symptom scores. | — |
Outcome results
None listed