Efficacy and Safety of Fixed Dose Combination GSP 301 Nasal Spray (NS) 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 and safety of GSP 301 NS compared to placebo NS and to individual monotherapies (comparators) as well as the efficacy of these monotherapies (comparators) versus placebo NS over 14 days of study treatment

Official Title
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A Double-Blind, Randomized, Parallel-Group, Comparative Study to Evaluate the Efficacy, Safety and Tolerability of a Fixed Dose Combination GSP 301 Nasal Spray (NS) Compared With Placebo Nasal Spray and Individual Monotherapy Formulations (Comparators) in Subjects (Aged 12 Years and Older) With Seasonal Allergic Rhinitis (SAR)

Conditions
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Seasonal Allergic Rhinitis

Intervention / Treatment
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* Drug: GSP 301 NS
* Drug: Olopatadine HCl NS
* Drug: Mometasone furoate NS
* Drug: GSP 301 Placebo NS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 12 years and older inclusive of either sex. Documented clinical history of SAR (for at least 2 years preceding the Screening Visit [Visit 1]) with exacerbations (clinical evidence of active symptoms) during the spring allergy season (tree/grass pollen) A 12-hour reflective TNSS ≥ 8 out of a possible 12 and a congestion score of ≥ 2 for the AM assessment at the Screening Visit (Visit 1). Exclusion Criteria: Pregnant or lactating women. Plans to travel outside the known pollen area for the investigative site for > 24 hours during the last 7 days of run in period. 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

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GSP 301 NS<br> | Drug: GSP 301 NS<br>* FDC of olopatadine HCl and mometasone furoate: 2 sprays in each nostril twice daily for 14 days<br>|
| Active Comparator: Olopatadine HCl NS<br> | Drug: Olopatadine HCl NS<br>* 2 sprays in each nostril twice daily for 14 days<br>|
| Active Comparator: Mometasone furoate NS<br> | Drug: Mometasone furoate NS<br>* 2 sprays in each nostril twice daily for 14 days<br>|
| Placebo Comparator: GSP 301 Placebo NS<br> | Drug: GSP 301 Placebo NS<br>* 2 sprays 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 in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment. | Reflective Total Nasal Symptom Score (rTNSS) was calculated as the sum of 12-hour reflective scoring of the severity of four nasal symptoms (nasal congestion, rhinorrhea, nasal itching, sneezing). Subjects responded on a 4-point severity scale with scores ranging 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). | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Seasonal Allergic Rhinitis