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



Status:Completed
Conditions:Allergy
Therapuetic Areas:Otolaryngology
Healthy:No
Age Range:12 - Any
Updated:4/17/2018
Start Date:August 2016
End Date:January 2017

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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)

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)


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.
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