Study In Adolescent And Adult Subjects 12 Years Of Age And Older With Seasonal Allergic Rhinitis To Assess Onset of Action
Status and phase
Conditions
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Details and patient eligibility
About
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 purpose of this study is to evaluate the onset of action of an investigational nasal spray, GW685698X aqueous nasal spray, versus vehicle placebo nasal spray in the treatment of seasonal allergic rhinitis caused by ragweed following a single dose of treatment in controlled pollen concentrations in an allergen challenge chamber.
Full description
Randomized, Double Blind, Placebo-Controlled, Single-Dose, Parallel-Group Study to Evaluate the Onset of Action of a Single Dose of Intranasal GW685698X Aqueous Nasal Spray 100 mcg in Adolescent and Adult Subjects (=12 years of age) With Seasonal Allergic Rhinitis Exposed to Ragweed Pollen in an Allergen Challenge Chamber
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Informed consent
- Outpatient
- Females must use appropriate contraception
- Diagnosis of seasonal allergic rhinitis
- 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 investigational product
Trial design
Primary purpose
Allocation
Interventional model
Masking
380 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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