A Study to Evaluate the Safety and Efficacy of a Nasal Spray to Treat Seasonal Allergies

Inclusion Criteria:

• Male and female patients 12 years of age and older

• Provide written informed consent/pediatric assent. If the patient is a minor, a parentor legal guardian must give written informed consent

• Screening Visit: Have a 12-hour reflective total nasal symptoms score ( TNSS) of atleast 8 out of a possible 12 and a congestion score of 2 or 3 on Day -7

• Randomization Visit: Have a 12-hour reflective total nasal symptoms score (TNSS) (AMor PM) of at least 8 on 3 separate assessments (one of which was within 2 days of Day 1, and can include the morning of Day 1) during the Lead-in Period. In addition, an AMor PM nasal congestion score of 2 or 3 must have been recorded on 3 separateassessments (one of which was within 2 days of Day 1, and can include the morning ofDay 1).

• Must have taken at least 10 doses of study medication during the lead-in period

• Randomization Visit: An instantaneous (TNSS) of ≥ 8 before beginning the onset ofaction assessment on Day 1

• Willing and able to comply with the study requirements

• At least a 2-year history of seasonal allergic rhinitis (SAR) during the fall pollenallergy season

• The presence of IgE-mediated hypersensitivity to local fall pollen confirmed by apositive response to either skin prick or intradermal testing within the last year. Apositive response is defined as a wheal diameter of at least 3 mm larger than thecontrol for the skin prick test or at least 7 mm larger than the control for theintradermal test.

• General good health and free of any disease or concomitant treatment that couldinterfere with the interpretation of the study results as determined by theinvestigator or the sponsor's medical officer

• Patients receiving immunotherapy injections (antigen desensitization) must be on astable maintenance regimen for at least 30 days before the first study visit (adjustments to regimen following a brief period of missed injections does notpreclude participation). Patients who are on maintenance doses of sublingualimmunotherapy may be considered for the trial on a case-by-case basis after discussionwith the sponsor's medical monitor or designee.

Exclusion Criteria:

• The use of any investigational drug within 30 days prior to Day -7. No investigationalproducts are permitted for use during the conduct of this study

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

• Women who are pregnant or nursing

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

• Respiratory tract infections within two weeks prior to Day -7

• Respiratory Infections requiring oral antibiotic treatment two weeks prior to Day -7

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

• Patients with asthma (with the exception of mild, intermittent asthma)

• Patients with significant pulmonary disease

• Patients with a known history of alcohol or drug abuse

• Existence of any surgical or medical condition, which in the opinion of theinvestigator or sponsor, might significantly alter the absorption, distribution,metabolism, or excretion of study drug

• Clinically relevant abnormal physical findings within 1 week of randomization which,in the opinion of the investigator, would interfere with the objectives of the studyor that may preclude compliance with the study procedures

• Planned travel outside the study area during the study period

• Family members and employees should be excluded

• Patients who received prohibited medications within specified timepoints in theprotocol.