A Study in Subjects With Perennial Allergic Rhinitis

A Multi-Center, Randomized, Parallel-Group, Double-Blind, Efficacy and Safety Study of INS37217 Nasal Spray Versus Placebo in Subjects With Perennial Allergic Rhinitis

The purpose of this study was to determine the efficacy and safety of the study drug compared to placebo for the treatment of subjects with perennial allergic rhinitis.

Inclusion Criteria:

• Have a documented history of allergy to perennial allergens and demonstrated sensitivity by the results of prick or intradermal skin testing.
• Have a self-reported history of at least mild, intermittent rhinorrhea and nasal blockage/stuffiness due to allergies.
• Have not started or had a change in immunotherapy regimen.

Exclusion Criteria:

• Have a physical obstruction in the nose.
• Will likely have an acute increase in severity of allergic rhinitis due to seasonal aeroallergens during the trial.
• Have acute or chronic sinusitis or had previous sinus surgery resulting in a significant change in the sinus or nasal anatomy.
• Have rhinitis medicamentosa or any other acute or chronic condition that could confound evaluations of nasal symptoms.
• Have asthma of sufficient severity to require use of excluded medications.
• Have taken any medications excluded as listed in the protocol.
• Have a clinically significant acute or chronic disease or clinically significant laboratory abnormality.
• Are a current smoker, recent smoker or past smoker as defined in the protocol.