The primary objective of this study was to compare Placebo to Captisol-Enabled Budesonide + Azelastine in a single spray and two separate sprays (Budesonide + Azelastine) in patients with Seasonal Allergic Rhinitis exposed to controlled ragweed pollen.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
108
nasal spray, one spray per nostril at time 0 plus one spray Placebo
nasal spray, one spray of each per nostril at time 0
nasal spray, one spray per nostril from each of 2 bottles at time 0
Allied Research International - Cetero Research
Mississauga, Ontario, Canada
Patient-rated Total Nasal Symptom Score
Time frame: 10 mins, 20 mins, 30 mins, 40 mins, 60 mins, 90 mins, 120 mins and then every hour up to 10 hours post dose
Patient-rated Total Symptom Score
Time frame: 10 mins, 20 mins, 30 mins, 40 mins, 60 mins, 90 mins, 120 mins and then every hour up to 10 hours post dose
Patient-rated EEC-RQLQ assessment
Time frame: -0.75 hours, 2 hours, 6 hours and 10 hours post dose
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