Effect of Loratadine/Montelukast Combination on Congestion in SAR Patients Exposed to Pollen in an EEU (Study P04822)

Inclusion Criteria:

• Ages 18 years or greater, of either sex, any race.

• A history of SAR due to ragweed for at least two consecutive ragweed seasons, asdiagnosed by the investigator, another physician, or subject-provided history.

• Positive skin prick test to ragweed allergen to be used in the EEU, unlesspreviously done within 12 months

• Minimum scores (diary evaluation time) must be achieved during pollen exposureduring both a Priming Visit and the Treatment Visit:

• A negative urine pregnancy test at Screening and prior to randomization at theTreatment Visit for all female subjects of childbearing potential.

• Use of a medically accepted method of birth control.

• In the judgment of the investigator, good health and freedom from any clinicallysignificant disease (other than SAR) that would interfere with the study schedule orprocedures, or compromise the subject's safety.

• The appropriate washout times from the prohibited medications.

Exclusion Criteria:

• Pregnancy, intention of becoming pregnant, or lactation.

• A situation or any condition that, in the opinion of the investigator, may interferewith optimal participation in the study.

• Use of any investigational drugs, including placebo, within 30 days of Screening andfor the duration of the study.

• Current participation in any other clinical study.

• Staff personnel directly involved with this study.

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

• Nasal structural abnormalities, including large nasal polyps or marked septaldeviation, that cause greater than 50% obstruction of nasal airflow.

• Previous enrollment (ie, signed informed consent) into this study.

• History of rhinitis medicamentosa.

• A history of anaphylaxis or severe or serious reaction to skin testing.

• A known potential for hypersensitivity, allergy, or idiosyncratic reaction to thestudy drugs or excipients.

• Narrow-angle glaucoma, increased intraocular pressure, urinary retention,hypertension, severe coronary artery disease, ischemic heart disease, diabetesmellitus, hyperthyroidism, renal impairment, or prostatic hypertrophy; currenttreatment with monoamine oxidase (MAO) inhibitors.

• An upper or lower respiratory tract infection within 28 days (4 weeks) beforePriming (Visit 2) and thereafter.).

• History of a positive test for HIV, TB (not due to vaccination), and hepatitis B (not due to vaccination) or C.

• Asthma that requires medication other than occasional (<= 3 uses per week) use of aninhaled short-acting beta-2 agonist.