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

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Collaborators: Kingston General Hospital; Kingston Health Sciences Centre
• Treatments: Azelastine; Cetirizine; Loratadine

Criteria

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.