A Study to Evaluate the Safety & Effectiveness of a Nasal Spray to Treat Seasonal Allergies

Inclusion Criteria:

• Male and female patients 12 years of age and older with a 2 year history of moderateto severe seasonal allergic rhinitis

• Must be in generally good health

• Must meet minimum symptom requirements, as specified in the protocol

• Must be willing and able to provide informed consent and to participate in all studyprocedures

• Positive skin test to a prevalent fall allergen

Exclusion Criteria:

• On focused Nasal Examination, the presence of any nasal mucosal erosion, nasalulceration, or nasal septal perforation at either the screening visit or randomizationvisit will disqualify the subject from the study.

• Other nasal disease(s)likely to affect deposition of intranasal medication, such assinusitis, rhinitis medicamentosa, clinically significant polyposis, or nasalstructural abnormalities.

• Nasal Surgery or sinus surgery within the previous year

• Chronic sinusitis-more than 3 episodes a year

• Planned travel outside of the study area during the study period

• The use of any investigational drug within 30 days prior to screening. Noinvestigational products are permitted for use during the conduct of the study.

• Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitalor sucralose (Splenda brand sweetener)

• Women who are pregnant or nursing

• Women of childbearing potential who are not abstinent or not practicing medicallyacceptable method of contraception

• Respiratory tract infection within 14 days prior to screening

• Respiratory tract infections requiring antibiotic treatment 14 days prior to screening

• Asthma (with the exception of mild, intermittent asthma). Subjects with mild,intermittent asthma who only require short-acting inhaled bronchodilators (not formore often tha twice a week) and who do not have nocturnal awakening as a result ofasthma are eligible for enrollment

• Significant pulmonary disease including COPD

• Clinically significant arrythmia or symptomatic cardiac conditions

• A known history of alcohol or drug abuse within the last 2 years

• Existence of any surgical or medical condition or physical laboratory findings, whichin the opinion of the investigator or sponsor's medical monitor, might significantlyalter the absorption, distribution, metabolism, or excretion of study drug; that mightsignificantly affect the subject's ability to complete this trial; or their safety inthis trial

• Clinically relevant abnormal physical findings which, in the opinion of theinvestigator, would interfere with the objectives of the study or that may precludecompliance with the study procedures.