Safety and Tolerability of a nasal spray in patients with Chronic allergic or nonallergic rhinitis

Exclusion Criteria1

• a. The use of any investigational drug within 30 days prior to screening. No other investigational products are permitted for use during the conduct of this study.b. Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose (Splenda® brand sweetener)c. Women who are pregnant or nursing.d. Women of childbearing potential who are not abstinent and not practicing a medically acceptable method of contraception. Female patients must practice an acceptable contraceptive technique for 30 days before randomization and agree to continue its use during treatment and for 30 days after the last dose of study drug. e. Nasal disease(s) likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa or clinically significant nasal polyposis or nasal structural abnormalities.f. Patients with asthma (with the exception of mild, intermittent asthma) or other significant pulmonary disease such as Chronic Obstructive Pulmonary Disease.g. Patients with a known history of alcohol or drug abuse.h. Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor, might significantly alter the evaluation of study.i. Clinically relevant abnormal history and/or physical findings which, in the opinion of the investigator or sponsor, would interfere with the objectives of the study or that may preclude compliance with the study procedures.j. Study site staff, immediate relatives of study site staff, or other individuals who would have access to the clinical study protocol.