Efficacy and Safety of GSP 301 Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (SAR)

Study Overview
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Brief Summary
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Study to evaluate the efficacy, safety and tolerability of GSP 301 NS compared with placebo NS and individual monotherapy formulations for the treatment of Seasonal Allergic Rhinitis (subjects 12 years of age and older)

Official Title
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A Double-Blind, Randomized, Parallel-Group Seasonal Allergic Rhinitis (SAR) Study to Evaluate the Efficacy, Safety and Tolerability of GSP 301 Nasal Spray Compared With Placebo Nasal Spray and Individual Monotherapy Formulations (Olopatadine Hydrochloride Nasal Spray and Mometasone Furoate Nasal Spray) in Adult and Adolescent Subjects (12 Years of Age and Older)

Conditions
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Seasonal Allergic Rhinitis (SAR)

Intervention / Treatment
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* Drug: GSP 301 NS
* Drug: GOM-NS
* Drug: GMM-2 NS
* Drug: GSP 301 placebo NS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and non-pregnant females who are 12 years of age and older. Documented clinical history of SAR (for at least 2 years preceding the Screening Visit [Visit 1]) with exacerbations (clinical evidence of active symptoms) for the relevant seasonal allergen during the Fall or mountain cedar allergy seasons (e.g., ragweed or mountain cedar pollen) A 12-hour rTNSS ≥8 out of a possible 12 and a congestion score ≥2 for the AM assessment at the Screening Visit (Visit 1). Exclusion Criteria: Pregnant or lactating women. History of anaphylaxis and/or other severe local reaction(s) to skin testing. History of positive test for HIV, Hepatitis B or Hepatitis C infection. Documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip. Subjects with an active pulmonary disorder or infection. Subjects with posterior subcapsular cataracts or glaucoma Plans to travel outside the known pollen area for the investigational site for 24 hours or longer during the last 7 days of the run-in period.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GSP 301 NS<br> | Drug: GSP 301 NS<br>* 2 spray in each nostril twice daily for 14 days<br>|
| Active Comparator: GOM-NS<br> | Drug: GOM-NS<br>* 2 spray in each nostril twice daily for 14 days<br>|
| Active Comparator: GMM-2 NS<br> | Drug: GMM-2 NS<br>* 2 spray in each nostril twice daily for 14 days<br>|
| Placebo Comparator: GSP 301 placebo NS<br> | Drug: GSP 301 placebo NS<br>* 2 spray in each nostril twice daily for 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score (rTNSS) | The Reflective Total Nasal Symptom Score (rTNSS) was assessed by 12-hour reflective scoring of the severity of four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching). Symptom scores ranged from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate). The rTNSS was calculated as the sum of the subject-reported severity scores for nasal symptoms, and value ranged from 0 (no signs/symptoms evident) to 12 (severe signs/symptoms that is hard to tolerate). | Baseline and day 14 |