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:

NCT00561717

EudraCT Number:

Not Available

Study Completed

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
70
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
Yes
Products
Astelin (Azelastine, BAYR9258)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Kingston General Hospital

Kingston, Canada, K7L 2V7

Status
Completed
 

Trial Design