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Sponsors and Collaborators: |
Bayer Kingston General Hospital |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00561717 |
Finding out how fast azelastine nasal spray works in subjects with hay fever.
Condition | Intervention | Phase |
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Seasonal Allergic Rhinitis |
Drug: Azelastine and placebo Drug: Loratadine and Placebo Drug: Cetirizine and Placebo Drug: Placebo and Placebo (spray and Tablet) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Efficacy Study |
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 |
Enrollment: | 60 |
Study Start Date: | October 2007 |
Study Completion Date: | February 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm 1: Experimental |
Drug: Azelastine and placebo
One Astelin spray per nostril plus one placebo tablet. In Cross-Over-Design with other arms.
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Arm 2: Active Comparator |
Drug: Loratadine and Placebo
One placebo spray per nostril plus one Loratadine 10 mg tablet. In Cross-Over-Design with other arms.
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Arm 3: Active Comparator |
Drug: Cetirizine and Placebo
One placebo spray per nostril plus one 10 mg Cetirizine tablet. In Cross-Over-Design with other arms.
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Arm 4: Placebo Comparator |
Drug: Placebo and Placebo (spray and Tablet)
One placebo spray per nostril plus one placebo tablet. In Cross-Over-Design with other arms.
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Bayer Consumer Care Inc. ( Medical Affairs Therapeutic Area Head ) |
Study ID Numbers: | 12962, 9427-B2171-22C (CR Number) |
Study First Received: | November 20, 2007 |
Last Updated: | October 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00561717 |
Health Authority: | Canada: Health Canada |
Seasonal Allergic Rhinitis Ragweed Pollen Allergy |
Otorhinolaryngologic Diseases Rhinitis Cetirizine Azelastine Histamine Naphazoline Oxymetazoline Methamphetamine Hypersensitivity Loratadine |
Respiratory Tract Diseases Respiratory Tract Infections Guaifenesin Phenylephrine Rhinitis, Allergic, Seasonal Hypersensitivity, Immediate Histamine phosphate Amphetamine Phenylpropanolamine Respiratory Hypersensitivity |
Respiratory System Agents Neurotransmitter Agents Immune System Diseases Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Asthmatic Agents Histamine Agents Enzyme Inhibitors Anti-Allergic Agents Nose Diseases Pharmacologic Actions |
Lipoxygenase Inhibitors Histamine Antagonists Autonomic Agents Therapeutic Uses Antipruritics Histamine H1 Antagonists Peripheral Nervous System Agents Histamine H1 Antagonists, Non-Sedating Dermatologic Agents Bronchodilator Agents |