Trial Condition(s):
Seasonal Allergic Rhinitis
A Randomized, Placebo Controlled Study to Determine the Efficacy and Speed of a Nasal Spray in Allergen Induced Seasonal Allergic Rhinitis (GEYSER)
Bayer Identifier:
12962
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Kingston General Hospital Kingston, Canada, K7L 2V7 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Crossover Assignment
Trial Arms:
4
Primary Outcome
- 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 baselineTimeframe: Up to 6 hours
Secondary Outcome
- Change from baseline for individual symptoms of allergic seasonal rhinitis; overall assessment of efficacyTimeframe: Effect over 6 hours
Additional Information
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