An Efficacy and Safety Evaluation of Nasacort AQ in Children Ages 2-5 Years With Perennial Allergic Rhinitis

Inclusion Criteria:

• Subjects will be male or female children ages 2-5 years with a history of at least 1year of perennial allergic rhinitis (PAR) with or without seasonal allergic rhinitis (SAR) characterized by nasal stuffiness, nasal discharge, sneezing, nasal itching, andtotal eye symptoms, and verified by positive skin test or radioallergosorbent test (RAST) to perennial allergen that is present in the subject's environment (documentedhistorical testing performed during the past year will be accepted).

• Subjects (assisted by a parent/guardian/care provider) must meet an aggregate symptomscore of at least 18 (out of a possible 36) for nasal stuffiness, nasal discharge andsneezing for both the reflective (previous 24 hours) and instantaneous symptom scoresrecorded in the morning

• Subjects must not have clinically relevant disease other than allergic rhinitis orhave clinically relevant deviations from normal on a physical examination.

• Subjects must not have been recently exposed to rhinitis medications prior toscreening

• Subjects must have no history of hypersensitivity to glucocorticoids or to anyexcipients of the formulation

• Subjects undergoing cosyntropin stimulation test must have a morning (8 AM ± 1 hour)pre-stimulation serum cortisol level ≥ 5 µg/dL and 30 minutes post-stimulation serumcortisol level ≥ 18 µg/dL at screening

Exclusion Criteria: Subjects presenting with any of the following will not be included in the study:

• Asthma, requiring chronic use of inhaled or systemic corticosteroids in the previous 6months; upper respiratory tract infection or sinus infection requiring antibiotictherapy within 2 weeks prior to screening or viral upper respiratory tract infectionwithin 7 days of screening.

• Nasal polyps, deviated septum, or nasal/facial anatomic abnormalities that interferewith symptom evaluation and/or use of intranasal corticosteroids

• Treatment with more than 2 courses of systemic corticosteroids (each course notexceeding 14 days) within 1 year of screening

• Use of intranasal or ocular corticosteroids within 2 weeks of screening

• Use of oral, inhaled, or intravenous corticosteroids within 1 month of screening

• Use of intramuscular or intra-articular corticosteroids within 3 months of screening

• Use of high potency dermatological corticosteroids within 1 month of screening

• Use of oral leukotriene modifiers within 1 week of screening

• Use of nasal or oral antihistamines or oral or nasal decongestants within 3 days ofscreening

• Current or history of cataract or glaucoma

• Treatment with any investigational product or use of an investigational device within 1 month of screening

• Immunotherapy, with the exception of a stable maintenance schedule, for at least 1month prior to screening

• History of hypersensitivity to glucocorticoids or to any excipients of the formulation

• Subject is the investigator or any sub-investigator, research assistant, pharmacist,study coordinator, or other staff or relative thereof directly involved in the conductof the protocol. Any waiver of these inclusion and exclusion criteria must be approved by the investigatorand the sponsor on a case-by-case basis prior to enrolling the subject. This must bedocumented by both the sponsor and the investigator. No subject will be allowed to enroll in this study more than once.