Clinical Equivalence Study of Fluticasone Propionate Nasal Spray, 50 mcg/Actuation vs. Flonase in Allergic Rhinitis Patients

Inclusion Criteria:

• Male or non-pregnant, non-lactating female 12 years or age or older.
• Signed informed consent form, which meets all criteria of current FDA regulations. Forpatients under the age of majority in the state the study is being conducted (18 yearsin most states) the parent or legal guardian should sign the consent form and thechild will be required to sign a patient "assent" form that will be written in such away as to be understandable to a child.
• If female and of child-bearing potential, have a negative urine pregnancy test and isprepared to abstain from sexual intercourse or use a reliable method of contraceptionduring the study. In order for hormonal birth control to be considered a reliablemethod the patient must have been on their regimen for at least 28 days.
• Documented positive allergic skin test, performed within the previous 12 months, toone or more of the allergens in season at the time the study is being conducted.
• A minimum of two consecutive years of previous history of seasonal allergic rhinitisto the pollen/allergen in season at the time the study is being conducted.
• A score of at least 6 on the reflective Total Nasal Symptom Score (rTNSS) and aminimum score of at least 2 for "nasal congestion" and a minimum score of at least 2for one of the remaining 3 symptoms representing the 12 hours prior to the screeningvisit.
• An average composite score of at least 6 on the reflective Total Nasal Symptom Score (rTNSS) and a minimum score of at least 2 for "nasal congestion" and a minimum scoreof at least 2 for one of the remaining 3 symptoms representing the last 3 days of the 7-day lead-in period before the randomization visit and the morning of the first dayof the randomization visit.

Exclusion Criteria:

• Under 12 years of age.
• Females who are pregnant, lactating, or likely to become pregnant during the study.
• Negative or lack of documented skin allergen test (performed within the previous 12months) to at least one of the allergens in season at the time of the study is beingconducted. The results of all positive shin allergen tests should be reported.
• Patients who suffer from chronic signs and symptoms of perennial allergic rhinitis (PAR) should be excluded from the study unless the Investigator assesses that thepatient's current signs and symptoms are a clear exacerbation of Seasonal AllergicRhinitis (SAR) rather than chronic PAR.
• Patients who suffer only from perennial allergic rhinitis or seasonal allergicrhinitis to a different allergen that that in season at the time the study isconducted.
• Previous history of less than 2 years of seasonal allergic rhinitis to thepollen/allergen in season at the time the study is being conducted.
• A total score of less that 6 on the reflective Total Nasal Symptom Score (rTNSS) or ascore of less than 2 for "nasal congestion" or a score of less than 2 for all 3 of theremaining symptoms.
• History of asthma over the previous 2 years that required chronic therapy. Occasionalacute or mild exercise induced asthma will be allowable on the condition that thetreatment of the attacks is restricted to beta-agonists only.
• Patients with nasal conditions, including infectious rhinitis, rhinitis medicamentosa,or atrophic rhinitis.
• Clinically significant nasal deformity (e.g. significantly deformed septum, nasalpolyps, or ulcers) or any recent nasal surgery or trauma that has not completelyhealed.
• Sinus infection within the previous 30 days or history of re-occuring sinusinfections.
• Patient has started immunotherapy (including topical or desensitization therapy) orchanged their dose of immunotherapy within 30 days of the first dose, or is likely tohave to start immunotherapy, or change their current dose during the study.
• Treatment for oral Candidiasis within 30 days of starting the study or a currentCandidiasis infection.
• Upper respiratory tract infection within the previous 30 days.
• Patients with a history of tuberculosis.
• Patients with the presence of glaucoma, cataracts, ocular herpes simplex,conjunctivitis, or other eye infection not related to the diagnosis of SAR within 14days of enrollment.
• The patient has had recent exposure (30 days) or was at risk of being exposed tochicken pox or measles.
• Patients with any untreated fungal, bacterial, or systemic viral infections within theprevious 30 days.
• Use of any ophthalmic steroids within 14 days or nasal, inhaled, or systemic steroidswithin 30 days of the study start.
• Use of medications that significantly inhibit the cytochrome P450 subfamily enzymeCYP3A4.
• Use of intranasal or systemic second-generation anti-histamines within 10 days ofenrollment.
• Use of intranasal cromolyn within 14 days of enrollment.
• Use of intranasal or systemic first-generation anti-histamines, leukotriene receptorantagonists or other nasal decongestants within 3 days of enrollment.
• Use of any tricyclic anti-depressant within 30 days of enrollment.
• Patients with attention-deficit disorder being treated with methylphenidate containingproducts that have not been on a stable dosing regimen for at least the 30 previousdays and who cannot remain on the same dosing regimen throughout the study.
• Desensitization therapy to the seasonal allergen that is causing the patients allergicrhinitis within the previous 6 months.
• Previous SAR and/or PAR that has proven unresponsive to steroid therapy.
• Any known hypersensitivity to fluticasone, other steroids, or any of the components ofthe study nasal sprays.
• Significant history or current evidence of chronic infectious disease, systemdisorder, organ disorder, or other medical condition that in the Investigator'sopinion would place the study patient at undue risk by participating, or couldjeopardize the integrity of the study evaluations.
• Receipt of any drug as part of a research study within 30 days prior to the firstdose.
• Planned travel outside of the local area for more than 2 consecutive days or 3 days intotal, during the patient's participation in the study.
• Previous participation in this study.
• The patient has a history or non-compliance with medical regimens or treatmentprotocols in previous clinical studies.
• The patient is a member of the investigational study staff or a member of the familyof the investigational study staff.
• The patient currently smokes cigarettes, cigars, and/or pipes and is a heavy smoker (for example, on average more than 10 cigarettes per day).