PK/PD and Steady State Efficacy Study of Bilastine Compared With Placebo Given Orally in the Treatment of the Symptoms of SAR in an EEC Model (5-arm)

Inclusion criteria

• Clinical history of SAR for the last two ragweed allergy seasons.
• A positive skin test within 12 months of screening to ragweed allergen.
• A minimum qualifying symptom score on both Visits, 2 and 3.
• Females must have a confirmed absence of pregnancy according to a negative urine pregnancy test.

Exclusion criteria

• Women who are pregnant, breastfeeding, or planning a pregnancy.
• History of more than mild asthma.
• History of clinically significant (as determined by the Investigator) active perennial allergic rhinitis to which the subject is regularly exposed.
• Non-allergic rhinitis (vasomotor or rhinitis medicamentosa).
• An anatomic abnormality that interferes with assessment of nasal function. - History of clinically significant recurrent sinusitis or chronic sinusitis. - Clinically significant (as determined by the Investigator) cardiovascular, hepatic, neurologic, psychiatric, endocrine, or other significant systemic disease that makes implementation of the protocol jeopardizing to the safety of the subject.
• A need for use of antihistamines or corticosteroids on a regular basis (systemic or topical).
• Currently taking monoamine oxidase (MAO) inhibitors.
• Taken any systemic corticosteroids, immunomodulators, or immune suppressive medications within four weeks prior to Visit 1.
• Taken any antihistamine within seven days prior to Visit 1 skin testing.
• Known current alcohol or drug abuse.
• Current participation in another clinical study involving an experimental treatment, or participation in such a study within 30 days prior to study entry. - History of generalized anaphylaxis requiring medical attention.
• Clinically significant abnormality of screening blood chemistry, hematology, or urinalysis.