Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray
Drug137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate
Other names: Perrigo Product
NCT Number: NCT02230696
To compare safety and efficacy of Perrigo's steroid drug product compared with an FDA approved steroid drug product in the treatment of subjects with seasonal allergic rhinitis.
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Notify Me12 year–65 year
All sexes
Interventional
Phase 3
Atlanta Allergy & Asthma Clinic, PA, Stockbridge, Georgia, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate
Other names: Perrigo Product
Placebo nasal spray
Time frame: Day 1 through Day 14
The symptoms included in the reflective Total Nasal Symptom Score (rTNSS) scale are nasal congestion/stuffy nose, nasal discharge/runny nose, sneezing, and itchy nose. Symptoms were scored on a four point scale, 0-3, for each assessment were calculated by totaling these four symptom scores for a maximum score of 12.
Time frame: Day 1 through Day 14
The symptoms included in the instantaneous Total Nasal Symptom Score (iTNSS) scale are nasal congestion/stuffy nose, nasal discharge/runny nose, sneezing, and itchy nose. Symptoms were scored on a four point scale, 0-3, for each assessment were calculated by totaling these four symptom scores for a maximum score of 12.
Time frame: Day 1, up to four hours post the first dose
This outcome measured the time to statistical significance of the reduction of signs/symptoms over a 4 hour period on Day 1 only by measuring the reduction in iTNSS scores. When the change from baseline was statistically significant, it was associated with a time to onset of the anti-histamine component of the formulation.
Subjects will record iTNSS scores for 4 hours post first randomized dose. The symptoms included in the instantaneous Total Nasal Symptom Score (iTNSS) scale are nasal congestion/stuffy nose, nasal discharge/runny nose, sneezing, and itchy nose. Symptoms were scored on a four point scale, 0-3, for each assessment were calculated by totaling these four symptom scores for a maximum score of 12.
Padagis LLC
Industry
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