This is a prospective, national, randomized, multicenter, parallel group, Phase III study that evaluates the effects of AI201901 in Allergic Rhinitis patients, where they will spray twice a day against azelastine into both nostrils during a 28-day follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
210
Twice daily inhaled AI201901 for 4 weeks
Twice daily inhaled Azelastine Hydrochloride for 4 weeks
Dokuz Eylul University
Izmir, Turkey (Türkiye)
Total Nasal Symptom Score
Achieve a statistically significant improvement in the symptoms of allergic rhinitis via Total Nasal Symptom Score (TNSS).
Time frame: 28 days
TNNSS; Total non nasal symptom score
In non-nasal symptom scores (TNNSS), AI201901 is similar compared to azelastine
Time frame: 28 days
The rhinoconjunctivitis quality of life scale (RQLQ)
The rhinoconjunctivitis quality of life scale (RQLQ) indicates that AI201901 is similar compared to azelastine
Time frame: 28 days
Odor Visual Analogue Score (VAS)
In Odor Visual Analogue Score (VAS) results, AI201901 is better than azelastine
Time frame: 28 days
Inspiratory peak flow meter (PNIF)
Inspiratory peak flow meter (PNIF) results show that AI201901 is similar compared to azelastine
Time frame: 28 days
Connecticut butanol odor threshold test
Connecticut butanol odor threshold tests show that AI201901 is similar compared to azelastine
Time frame: 28 days
Rhinoscopic Assessment Scale
Results of the Rhinoscopic Assessment Scale show that AI201901 is better than azelastine
Time frame: 28 days
Safety of AI201901
Demonstration of the safety of AI201901 by comparing the number of participants with treatment-related adverse events in each arm.
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Time frame: 28 days