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

• Status: Completed
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Glenmark Specialty S.A.

Criteria

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