Study In Adults And Adolescents With Seasonal Allergic Rhinitis.
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Informed consent.
- Must be an outpatient.
- Females must be using appropriate contraception.
- Must have diagnosis of seasonal allergic rhinitis, adequate exposure to allergen.
- Must be able to comply with study procedures.
- Must be literate.
Exclusion criteria
- A significant concomitant medical condition.
- Use of corticosteroids or allergy or medications or tobacco.
- Clinically significant abnormal ECG.
- Laboratory abnormality.
- Positive pregnancy test.
- Allergy to any component of the investigational product.
Trial design
Primary purpose
Allocation
Interventional model
Masking
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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