Clinical Equivalence of Azelastine Hydrochloride and Fluticasone Propionate, 137/50 mcg Nasal Spray to Dymista™

Inclusion Criteria:

- Male or non-pregnant, non-lactating female 12 years of age or older.

- Signed informed consent form, which meets all criteria of current FDA regulations.
For patients under the age of majority in the state the study is being conducted (18
years in most states) the parent or legal guardian should sign the consent form and
the child will be required to sign a patient "assent" form that will be written in
such a way to be understandable to a child.

- Documented positive allergic skin test, performed within the previous 12 months, to
one 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 Rhinitis
(SAR) to the pollen/allergen in season at the time the study is being conducted.

- Eligibility requirements for placebo lead-in period: A total (composite) score of at
least 6 on the reflective Total Nasal Symptom Score (rTNSS) with a minimum of at
least 2 for "nasal congestion" and a minimum score of at least 2 for one of the
remaining 3 symptoms and total (composite) score of at least 4 on the reflective
Total Ocular Symptom Score (rTOSS). These scores represent the 12 hours before the
screening visit.

- In addition to requirements above, patients should have the following at the end of
the placebo lead-in period and before randomization: 1) average composite score of at
least 6 on the rTNSS with a minimum average score of at least 2 for "nasal
congestion" and a minimum average score of at least 2 for one of the remaining 3
symptoms, and 2) average composite score of at least 4 on the rTOSS. These scores
represent the 3 days of the 7 day placebo run-in period before the Randomization
visit and the morning of the first day of 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 12
months) to at least one of the allergens in season at the time the study is being
conducted. The results of all positive skin allergen test results 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 the
patient's current signs and symptoms are a clear exacerbation of Seasonal Allergic
Rhinitis (SAR) rather than the chronic PAR.

- Patients who suffer only from PAR or SAR to a different allergen than that in season
at the time the study is conducted.

- Previous history of less than 2 years of SAR to the pollen/allergen in season at the
time the study is conducted.

- Before the placebo lead-in period, the patient has a total score of less than 6 on
the rTNSS or a score less than 2 for "nasal congestion". Any patient who meets the
minimum individual nasal symptom score requirements at the start of the placebo
lead-in period but no longer meets the requirements prior to the randomized active
treatment period of the study cannot continue in the active treatment period.

- At the end of the placebo lead-in period and before randomization, the patient has an
average composite score of less than 6 on the rTNSS and an average composite score of
less than 4 on the rTOSS.

- History of asthma over the previous 2 years that required chronic therapy. Occasional
acute or mild exercise induced asthma will be allowable on the condition that the
treatment 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 or any recent nasal surgery or trauma that has
not completely healed.

- Sinus infection within the previous 30 days or history or re-occurring sinus
infections.

- Patient has started immunotherapy or changed their dose of immunotherapy within 30
days of the first placebo lead-in dose or is likely to have to start immunotherapy,
or change their current dose during the study.

- Treatment for oral Candidiasis within 30 days of starting the study or a current oral
Candidiasis infection.

- Upper respiratory tract infection within the previous 30 days.

- Patients with a history of tuberculosis.

- Patients with presence of glaucoma, cataracts, ocular herpes simplex, conjunctivitis,
or other eye infection not related to the diagnosis of SAR within 14 days of
enrollment.

- The patient has had recent exposure (30 days) or was at risk of being exposed to
chicken pox or measles.

- Patients with any untreated fungal, bacterial, or systemic viral infections within
the previous 30 days.

- Use of any ophthalmic steroids within 14 days or nasal, inhaled, or systemic steroids
within 30 days of the study start. Super or high potency topical steroids should not
be used during the study.

- Use of medications that significantly inhibit the cytochrome P450 subfamily enzyme
CYP3A4.

- Use of intranasal or systemic second-generation anti-histamines within 10 days or
enrollment.

- Use of intranasal cromolyn within 14 days of enrollment.

- Use of intranasal or systemic first-generation anti-histamines, leukotriene receptor
antagonsits 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
containing products that have not been on a stable regimen for at least the 30
previous days and who cannot remain of the same dose throughout the study.

- Desensitization therapy to the seasonal allergen that is causing the patient's
allergic rhinitis within the previous 6 months.

- Previous SAR and/or PAR that has proven unresponsive to steroid therapy.

- Any known hypersensitivity to azelastine hydrochloride, fluticasone propionate, other
steroids, or any components of the study nasal spray.

- Significant history or current evidence of chronic infectious disease, system
disorder, organ disorder, or other medical condition that in the Investigator's
opinion would place the patient at undue risk by participating or could jeopardize
the integrity of the study evaluations.

- Receipt of any drug as part of a research study within 30 days prior to the first
placebo lead-in dose.

- Planned travel outside of the local area for more than 2 consecutive days or 3 days
in total, during the patient's participation in the study.

- Previous participation in this study.

- The patient has a history of non-compliance with medication regimens or treatment
protocols in previous clinical studies.

- The patient is a member of the investigational study staff or a member of the family
of 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).