Long Term Safety and Efficacy of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Perennial Allergic Rhinitis (PAR)



Status:Completed
Conditions:Allergy
Therapuetic Areas:Otolaryngology
Healthy:No
Age Range:12 - Any
Updated:9/15/2018
Start Date:April 2016
End Date:July 2017

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A Double-Blind, Randomized, Parallel-Group Study to Evaluate Long-Term Safety, Tolerability, and Efficacy of a Fixed Dose Combination GSP 301 Nasal Spray Compared With Two Placebo Nasal Spray Formulations in Subjects (Aged 12 Years and Older) With Perennial Allergic Rhinitis (PAR)

To evaluate the long term safety and efficacy of GSP 301 NS compared to 2 placebo NS
formulations for the treatment of perennial allergic rhinitis (subjects 12 years of age and
older)


Inclusion Criteria:

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

2. Documented clinical history of PAR (for at least 2 years preceding the Screening Visit
[Visit 1]) and exhibiting a documented positive skin prick test (wheal diameter at
least 3 mm greater than negative diluent control wheal) to at least 1 allergen known
to induce PAR. Documentation of a positive result within 12 months prior to the
Screening Visit (Visit 1) is acceptable.

Exclusion Criteria:

1. Pregnant or lactating women.

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

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

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

5. Subjects with an active pulmonary disorder or infection.

6. Subjects with posterior subcapsular cataracts or glaucoma
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