Effects of Loratadine/Montelukast vs Pseudoephedrine and Placebo in Patients With Seasonal Allergic Rhinitis (Study P04095) (COMPLETED)

Inclusion Criteria:

• Aged 15 years or older, of either sex and of any race.

• At least a 2-year documented history of SAR with symptoms during the study season.

• A positive skin-prick test response to seasonal

• Clinically symptomatic at Screening and at the Baseline Visits

• General good health.

• Freedom from any clinically significant disease, other than SAR, that wouldinterfere with the study evaluations.

• Willingness (subjects and/or a parent/guardian) to give written informed consent andability to adhere to dosing and visit schedules and meet study requirements.

• Negative pregnancy test

Exclusion Criteria:

• A history of anaphylaxis and/or other severe local reaction(s) to skin testing.

• Asthma requiring chronic use of inhaled or systemic corticosteroids.

• Current or history of frequent, clinically significant sinusitis or chronic purulentpostnasal drip.

• Rhinitis medicamentosa.

• A history of allergies to more than two classes of medications or allergy to orintolerance of antihistamines, montelukast, or pseudoephedrine.

• An upper respiratory tract or sinus infection that required antibiotic therapywithout at least a 14 day washout prior to the Screening Visit, or a viral upperrespiratory infection within 7 days before the Screening Visit.

• Nasal structural abnormalities, including large nasal polyps and marked septaldeviations, that significantly interfere with nasal air flow.

• Dependence (in the opinion of the investigator) on nasal, oral, or oculardecongestants, nasal topical antihistamines, or nasal steroids.

• Narrow-angle glaucoma, increased intraocular pressure, urinary retention,hypertension, severe coronary artery disease, ischemic heart disease, diabetesmellitus, hyperthyroidism, renal impairment, or prostatic hypertrophy, and thosereceiving monamine oxidase (MAO) inhibitor therapy.

• Use of any drug in an investigational protocol in the 30 days before the ScreeningVisit.

• Current immunotherapy (desensitization therapy), unless on a regular maintenanceschedule prior to the Screening Visit, which should be maintained for the remainderof the study. No desensitization treatment within 24 hours before any visit.

• Requirement for chronic use of tricyclic antidepressants.

• Pregnancy or lactation.

• 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 diary card.

• Significant medical condition(s) that, in the judgment of the investigator, mightinterfere with the study or require treatment.

• Compromised ability to provide informed consent..

• A history of noncompliance with medications or treatment protocols.