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
Summary
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
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Kingston, Ontario K7L 2V7, Canada
Additional Information
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Starting date: October 2007
Last updated: May 5, 2013
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