Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Efficacy Study

Study Primary Completion Date: February 2008

Intervention(s) in this Clinical Trial

• Drug: Azelastine and placebo
  • One Astelin spray per nostril plus one placebo tablet. In Cross-Over-Design with other arms.
• Drug: Loratadine and Placebo
  • One placebo spray per nostril plus one Loratadine 10 mg tablet. In Cross-Over-Design with other arms.
• Drug: Cetirizine and Placebo
  • One placebo spray per nostril plus one 10 mg Cetirizine tablet. In Cross-Over-Design with other arms.
• Drug: Placebo and Placebo (spray and Tablet)
  • One placebo spray per nostril plus one placebo tablet. In Cross-Over-Design with other arms.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 1
• Active Comparator: Arm 2
• Active Comparator: Arm 3
• Placebo Comparator: Arm 4

Primary Measures

• Onset of action measured by change in total nasal symptom score Until "Onset of action" = until drug demonstrates and maintains a change greater than placebo compared to baseline
  • Time Frame: Up to 6 hours
    Safety Issue?: No

Secondary Measures

• Change from baseline for individual symptoms of allergic seasonal rhinitis; overall assessment of efficacy
  • Time Frame: Effect over 6 hours
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Bayer

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Information obtained from ClinicalTrials.gov on January 08, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00561717

Study ID Number: 12962

ClinicalTrials.gov Identifier: NCT00561717

Health Authority: Canada: Health Canada

Click here and search for drug information provided by the FDA

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product

Click here to find results for studies related to marketed products