A Randomized, Placebo Controlled Study to Determine the Efficacy and Speed of a Nasal Spray in Allergen Induced Seasonal Allergic Rhinitis

A Four-Way Double-Blind, Randomized, Placebo Controlled Study to Determine the Efficacy and Speed of Azelastine Nasal Spray and Antihistaminic Agents in Adult Subjects With Allergen Induced Seasonal Allergic Rhinitis

Finding out how fast azelastine nasal spray works in subjects with hay fever.

Inclusion Criteria:

• History of seasonal allergic rhinitis to ragweed pollen for last 2 consecutive seasons;
• Positive response to skin prick test to ragweed allergen at screening;
• Be willing to participate in the trial.

Exclusion Criteria:

• History of hypersensitivity to azelastine;
• Females who are pregnant or lactating;
• Relative chronic sinusitis or nasal structural abnormalities causing greater than 50% obstruction;
• Asthma that requires other than occasional use of inhaled short-acting beta-2 antagonist;
• Known non-responsiveness to antihistamines;
• Alcoholism or drug abuse within 2 yrs. of screening;
• Current or regular use within 6 months of any type of tobacco product;
• Evidence of any clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or malignancies within the last 5 years;
• History of a positive test to HIV, TB, hepatitis B or C.