To Study GSP 301 in Patients With Seasonal Allergic Rhinitis



Status:Completed
Conditions:Allergy
Therapuetic Areas:Otolaryngology
Healthy:No
Age Range:12 - Any
Updated:7/16/2016
Start Date:December 2014
End Date:February 2015

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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) and With Seasonal Allergic Rhinitis (SAR)

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


Key Inclusion Criteria:

1. Aged ≥12 years and older inclusive of either sex.

2. 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

3. 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:

1. Pregnant or lactating women.

2. Plans to travel outside the known pollen area for the investigative site for > 24
hours during the last 7 days of run in period.

3. 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.

4. History of anaphylaxis and/or other severe local reaction(s) to skin testing.

5. History of positive test for HIV, Hepatitis B or Hepatitis C infection.

6. Documented evidence of acute or significant chronic sinusitis or chronic purulent
postnasal drip.

7. Subjects with an active pulmonary disorder or infection.

8. Subjects with posterior subcapsular cataracts or glaucoma.
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