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

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