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)

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.