The Purpose of this study is to evaluate the safety and efficacy of MP03-36 (0.15% azelastine hydrochloride)at dosages of 2 sprays per nostril once daily and 2 sprays per nostril twice daily in patients with seasonal allergic rhinitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
617
1644 mcg, 2 sprays per nostril twice daily AM \& PM)
822 mcg azelastine hydrochloride 0.15%, 2 sprays per nostril once daily (AM) and 0mg placebo spray 2 sprays per nostril once daily (PM)
1096 mcg, Azelastine 0.1%,2 sprays per nostril twice daily (AM \& PM)
Change from baseline in 12-hour reflective total nasal symptoms score(TNSS) for the entire 14-day study period compared to placebo
Time frame: 14 Days
Change from baseline in instantaneous total nasal symptoms score (TNSS) for the entire 14-day study period compared to placebo
Time frame: 14 Days
Change from baseline to Day 14 in Roland Quality of Life Questionnaire (RQLQ )compared to placebo
Time frame: 14 Days
Change From Baseline on Direct Visual Nasal Exams
Time frame: 14 Days
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Allergy and Asthma Associates of CA
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Colorado Allergy and Asthma Centers, PC
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Coastal Allergy and Asthma P.C.
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...and 20 more locations