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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:
ClinicalTrials.gov Identifier:
NCT00561717
First Posted: November 21, 2007
Last Update Posted: May 7, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Kingston General Hospital
Information provided by:
Bayer
  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
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Change from baseline for individual symptoms of allergic seasonal rhinitis; overall assessment of efficacy [ Time Frame: Effect over 6 hours ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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) ( Other Identifier: company internal )
First Submitted: November 20, 2007
First Posted: November 21, 2007
Last Update Posted: May 7, 2013
Last Verified: May 2013

Keywords provided by Bayer:
Seasonal Allergic Rhinitis
Ragweed
Pollen
Allergy

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