GEYSER
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
Sponsor study identifier
Secondary identifiers
OTHER · company internal
interventional
70
1 country
1
Study Start
October 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2007
Actual (reported)Study Completion
February 2008
Actual (reported)Finding out how fast azelastine nasal spray works in subjects with hay fever.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2007
Date type not reportedThis date has not been verified as actual or estimated.
November 20, 2007
Actual (reported)November 21, 2007
Actual (reported)December 2007
Actual (reported)February 2008
Actual (reported)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
Up to 6 hours
Change from baseline for individual symptoms of allergic seasonal rhinitis; overall assessment of efficacy
Effect over 6 hours
One Astelin spray per nostril plus one placebo tablet. In Cross-Over-Design with other arms.
One placebo spray per nostril plus one Loratadine 10 mg tablet. In Cross-Over-Design with other arms.
Kingston, Ontario, K7L 2V7, Canada
Tenn MW, Steacy LM, Ng CC, Ellis AK. Onset of action for loratadine tablets for the symptomatic control of seasonal allergic rhinitis in adults challenged with ragweed pollen in the Environmental Exposure Unit: a post hoc analysis of total symptom score. Allergy Asthma Clin Immunol. 2018 Jan 16;14:5. doi: 10.1186/s13223-017-0227-4. eCollection 2018.
Bayer Study Director
Bayer
70 participants (actual enrollment reported by the registry).
First Submitted
November 20, 2007
First Posted
November 21, 2007
Study Start
October 2007
Date type not reportedThis date has not been verified as actual or estimated.
One placebo spray per nostril plus one 10 mg Cetirizine tablet. In Cross-Over-Design with other arms.
One placebo spray per nostril plus one placebo tablet. In Cross-Over-Design with other arms.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
December 2007
Actual (reported)Study Completion
February 2008
Actual (reported)Last Updated
May 7, 2013
Record last verified: 2013-05
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Source: ClinicalTrials.gov.
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