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

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).