check_circleStudy Completed
Seasonal Allergic Rhinitis
Bayer Identifier:
12962
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
A Randomized, Placebo Controlled Study to Determine the Efficacy and Speed of a Nasal Spray in Allergen Induced Seasonal Allergic Rhinitis
Trial purpose
Finding out how fast azelastine nasal spray works in subjects with hay fever.
Key Participants Requirements
Sex
BothAge
18 - 65 YearsTrial summary
Enrollment Goal
70Trial Dates
October 2007 - February 2008Phase
Phase 4Could I Receive a placebo
YesProducts
Astelin (Azelastine, BAYR9258)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Kingston General Hospital | Kingston, K7L 2V7, Canada |
Primary Outcome
- 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 baselinedate_rangeTime Frame:Up to 6 hoursenhanced_encryptionnoSafety Issue:
Secondary Outcome
- Change from baseline for individual symptoms of allergic seasonal rhinitis; overall assessment of efficacydate_rangeTime Frame:Effect over 6 hoursenhanced_encryptionnoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Crossover AssignmentTrial Arms
4