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
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, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Azelastine
Cetirizine
Loratadine
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Lipoxygenase Inhibitors
Enzyme Inhibitors
Anti-Allergic Agents
Therapeutic Uses
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on April 15, 2014