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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 (GEYSER)

This study has been completed.
Sponsor:
Collaborator:
Kingston General Hospital
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00561717
First received: November 20, 2007
Last updated: May 5, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention Phase
Seasonal Allergic Rhinitis
Drug: Azelastine and placebo
Drug: Loratadine and Placebo
Drug: Cetirizine and Placebo
Drug: Placebo and Placebo (spray and Tablet)
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 [ Time Frame: Up to 6 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline for individual symptoms of allergic seasonal rhinitis; overall assessment of efficacy [ Time Frame: Effect over 6 hours ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: October 2007
Study Completion Date: February 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Azelastine and placebo
One Astelin spray per nostril plus one placebo tablet. In Cross-Over-Design with other arms.
Active Comparator: Arm 2 Drug: Loratadine and Placebo
One placebo spray per nostril plus one Loratadine 10 mg tablet. In Cross-Over-Design with other arms.
Active Comparator: Arm 3 Drug: Cetirizine and Placebo
One placebo spray per nostril plus one 10 mg Cetirizine tablet. In Cross-Over-Design with other arms.
Placebo Comparator: Arm 4 Drug: Placebo and Placebo (spray and Tablet)
One placebo spray per nostril plus one placebo tablet. In Cross-Over-Design with other arms.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00561717

Locations
Canada, Ontario
Kingston, Ontario, Canada, K7L 2V7
Sponsors and Collaborators
Bayer
Kingston General Hospital
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Medical Affairs Therapeutic Area Head, Bayer Consumer Care Inc.
ClinicalTrials.gov Identifier: NCT00561717     History of Changes
Other Study ID Numbers: 12962, 9427-B2171-22C (CR Number)
Study First Received: November 20, 2007
Last Updated: May 5, 2013
Health Authority: Canada: Health Canada

Keywords provided by Bayer:
Seasonal Allergic Rhinitis
Ragweed
Pollen
Allergy

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Rhinitis, Allergic, Seasonal
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections
Azelastine
Cetirizine
Loratadine
Anti-Allergic Agents
Anti-Asthmatic Agents
Antipruritics
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Enzyme Inhibitors
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Lipoxygenase Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 25, 2014