Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg QD in the Treatment of Seasonal Allergic Rhinitis (Study P05106)(COMPLETED)

Inclusion Criteria:

• Must be 12 years of age or older, of either sex and of any race.
• Must have at least a 2-year documented history of SAR which exacerbates during thestudy season.
• Must have a positive skin-prick test response to an appropriate seasonal allergen atScreening (Visit 1). IgE-mediated hypersensitivity to an appropriate seasonal allergen (ie, prevailing trees and/or grasses) must be documented by a positive response to theskin prick test with wheal diameter at least 3 mm larger than diluent control after 20minutes.
• Must be clinically symptomatic at the Screening Visit.
• Must be clinically symptomatic at the Baseline Visit.
• Must be in general good health as confirmed by routine clinical and laboratory testingand ECG results. Clinical laboratory test (CBC, blood chemistries, and urinalysis)must be within normal limits or clinically acceptable to the investigator and thesponsor.
• Must be free of any clinically significant disease, other than SAR, that wouldinterfere with the study evaluations.
• A subject and/or a parent/guardian must be willing to give written informed consentand must be able to adhere to dosing and visit schedules and meet study requirements.
• A female subject of childbearing potential must have a negative serum pregnancy test (HCG) at Screening. Nonsterile and premenopausal female subjects must be using amedically acceptable method of birth control, ie, double barrier method, oralcontraceptive, hormonal implant, or depot injectable prior to Screening and during thestudy.

Exclusion Criteria:

• A history of anaphylaxis and/or other severe local reaction(s) to skin testing.
• A subject with asthma who require chronic use of inhaled or systemic corticosteroids.
• Current or history of frequent, clinically significant sinusitis or chronic purulentpostnasal drip.
• A subject with rhinitis medicamentosa.
• A history of allergies to more than two classes of medications or who are allergic toor cannot tolerate nasal sprays.
• A subject who have had an upper respiratory tract or sinus infection that requiredantibiotic therapy without at least a 14-day washout prior to the Screening Visit, orwho have had a viral upper respiratory infection within 7 days before the ScreeningVisit.
• A subject who has nasal structural abnormalities, including large nasal polyps andmarked septal deviations, which significantly interfere with nasal air flow.
• A subject who, in the opinion of the investigator, is dependent on nasal, oral, orocular decongestants, nasal topical antihistamines, or nasal steroids.
• Use of any drug in an investigational protocol in the 30 days before the ScreeningVisit.
• A subject on immunotherapy (desensitization therapy), unless the subject is on aregular maintenance schedule prior to the Screening Visit and will stay on thisschedule for the remainder of the study. A subject may not receive desensitizationtreatment within 24 hours before any visit.
• Pregnant or nursing females.
• Family member of the investigation study staff.
• Current evidence of clinically significant hematopoietic, cardiovascular, hepatic,renal, neurologic, psychiatric, autoimmune disease, or other disease that precludesthe subject's participation in the study. Particular attention should be given toexclude subjects with conditions that would currently interfere with the absorption,distribution, metabolism, or excretion of the study drug or interfere with thesubject's ability to complete or reliably complete the diaries.
• Significant medical condition(s) that, in the judgment of the investigator, mightinterfere with the study or require treatment.
• A subject whose ability to provide informed consent is compromised.
• A subject with a history of noncompliance with medications or treatment protocols.