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

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Seasonal Allergic Rhinitis

Intervention: Azelastine and placebo (Drug); Loratadine and Placebo (Drug); Cetirizine and Placebo (Drug); Placebo and Placebo (spray and Tablet) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer


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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

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 baseline

Secondary outcome: Change from baseline for individual symptoms of allergic seasonal rhinitis; overall assessment of efficacy


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


Inclusion Criteria:

- History of seasonal allergic rhinitis to ragweed pollen for last 2 consecutive


- 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%


- Asthma that requires other than occasional use of inhaled short-acting beta-2


- 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.

Locations and Contacts

Kingston, Ontario K7L 2V7, Canada
Additional Information

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Starting date: October 2007
Last updated: May 5, 2013

Page last updated: August 23, 2015

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