To Study GSP 301 in Patients With Seasonal Allergic Rhinitis

Study Overview
=================
Brief Summary
-----------------
Study to evaluate the two different strengths and dose regimen of GSP 301 to be effective in treatment of seasonal allergic rhinitis.

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

Conditions
-----------------
Seasonal Allergic Rhinitis

Intervention / Treatment
-----------------
* Drug: GSP 301-1 NS (QD)
* Drug: GSP 301-2 NS (BID)
* Drug: GSP 301 Placebo NS
* Drug: Olopatadine HCl-1 NS (QD)
* Drug: Olopatadine HCl-2 NS (BID)
* Drug: Mometasone Furoate-1 NS (QD)
* Drug: Mometasone Furoate-2 NS (BID)


Participation Criteria
=================
Eligibility Criteria
-----------------
Key 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 study season for the mountain cedar 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). Key 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 nasal polyps of other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma (such as nasal piercing) or surgery, atopic dermatitis or rhinitis medicamentosa. 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
-----------------
Minimum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: GSP 301 Placebo NS<br> | Drug: GSP 301 Placebo NS<br>* GSP 301 placebo NS administered as 2 sprays/nostril<br>|
| Experimental: GSP 301-1 NS (QD)<br> | Drug: GSP 301-1 NS (QD)<br>* GSP 301-1 NS (665 μg olopatadine hydrochloride/50 μg mometasone furoate) administered as 2 sprays/nostril<br>|
| Experimental: GSP 301-2 NS (BID)<br> | Drug: GSP 301-2 NS (BID)<br>* GSP 301-2 NS (665 μg olopatadine hydrochloride/25 μg mometasone furoate) administered as 2 sprays/nostril<br>|
| Active Comparator: Olopatadine HCl-1 NS (QD)<br> | Drug: Olopatadine HCl-1 NS (QD)<br>* Olopatadine HCl-1 NS (665 μg) administered as 2 sprays/nostril<br>|
| Active Comparator: Olopatadine HCl-2 NS (BID)<br> | Drug: Olopatadine HCl-2 NS (BID)<br>* Olopatadine HCl-2 NS (665 μg) administered as 2 sprays/nostril<br>|
| Active Comparator: Mometasone Furoate-1 NS (QD)<br> | Drug: Mometasone Furoate-1 NS (QD)<br>* Mometasone furoate -1 NS (50 μg) administered as 2 sprays/nostril<br>|
| Active Comparator: Mometasone Furoate-2 NS (BID)<br> | Drug: Mometasone Furoate-2 NS (BID)<br>* Mometasone furoate-2 NS (25 μg) administered as 2 sprays/nostril<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in rTNSS From Baseline to End of Treatment | Subjects were asked to assess rTNSS (reflective Total Nasal Symptom Score), ie, an evaluation of symptom severity over the past 12 hours prior to the recording of the score. The TNSS was defined as the sum of the subject-reported symptom severity scores for the following four nasal symptoms, recorded by each subject in the diary: rhinorrhea, sneezing, nasal congestion, nasal itching. The total rTNSS scores for all four symptoms (i.e, the lowest possible score (0) and the highest possible score (12).) Higher score means a worse outcome. The severity scale for each symptom evaluation was defined as follows: 0 = absent (no sign/symptom evident) 1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated) 2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable) 3 = severe (sign/symptom that is hard to tolerate [i.e., causes interference with activities of daily living and/or sleeping]) | 14 days |